{
 "中国药典 稳定性 加速试验 长期试验 30℃ 65% 40℃ 75% 原料药 通则": [
  {
   "title": "药物稳定性研究的思考_摩熵医药",
   "url": "https://www.pharnexcloud.com/zixun/sd_4179",
   "description": "中国药典2015年版四部通则9001《原料药物与制剂稳定性试验指导原则》规定：加速试验要求3批样品，按市售包装进行考察，在温度40℃±2℃，相对湿度75%±5%条件放置6个月，所用设备应能控制温度±2℃、相对湿度±5%，并能对真实温度与湿度进行监测，在第1、2、3、6 个月末分别取样一次，按稳定性重点考察项目检测。长期试验也要求3批样品，按市售包装进行考察，在温度25℃±2℃，相对湿度60%±10%条件放置12个月，或在温度30℃±2℃，相对湿度65%±5%条件放置12个月，在第3、6、9、12、18、24、36月末分别取样一次，按稳定性重点考察项目检测。24个月以后每年一次，考察时间一般会比有效期时间长。仿制药注册申报中稳定性考察往往需要与参比制剂进行对比，例如加速6月，长期6、12、24、36月等时间点的对比，具体要求需结合品种特点和企业规定进行。\n\n以片剂为例，加速和长期试验的各个时间点的检测项目举例如下：\n\n表4. 加速试验各时间点的检测项目\n\n表5. 长期试验各时间点的检测项目 [...] 表5. 长期试验各时间点的检测项目\n\n对于不同气候区域、不同剂型、不同贮藏条件（如温度）、特殊包材的原料药和制剂的稳定性考察，可以参考中国药典2015年版四部通则9001《原料药物与制剂稳定性试验指导原则》、2015年版CFDA《化学药物（原料药和制剂）稳定性研究技术指导原则（修订）》中规定的条件进行设计。此外，文献中列出的设计思路也可以借鉴，如表6所示的完全研究设计。值得说明的是，虽然指导原则规定“当加速试验6个月中任何时间点的质量发生了显著变化，则应进行中间条件试验”，但在实际中通常是加速、中间条件、长期试验同时放样进行考察的。\n\n表6. 常用稳定性试验完全研究设计\n\n除了上述列举的每个点都进行考察的完全研究设计外，还有简化研究设计（包括括号法和矩阵法）。由于在国内申报时这种方法并不常用，因此仅将其基本设计思路列表如下。\n\n表7. 括号法设计模式\n\n表8. 矩阵法设计模式 [...] 3、稳定性试验的设计\n\nCFDA化学药品新注册分类申报资料要求（试行）（80号令）中规定在申报时，加速和长期条件结果列表中应详细提供稳定性考察的相关资料，包括样品的全检报告复印件、加速与长期试验开始日期、留样时样品放置的具体地点及恒温柜编号、各时间点质量考察用样品的具体数量等（示例见表3）。这些规定设计和整理资料时应注意。\n\n表3. 加速试验结果（以片剂为例）\n\n具体稳定性考察中，一般在全检合格时间点后即可以开始放样、每个稳定性时间点的放样量一般为理论单倍检验量的2-3倍，微生物限度一般与单倍检验量相同。实际取样时间应该与放样时计算的理论时间点一致，如遇特殊情况可以适当提前或延迟几天，需在取样记录里备注上原因。\n\n有的单位规定取样时间1个月加速不允许提前和推迟取样，两个月允许±1天，三个月允许±1周，六个月允许±2周，一年后允许±四周。但这种情况原则上是应该严格控制的，例如三个月以上的允许±3天，且在实验记录或申报资料中应进行说明提前或推迟取样的原因，但具体问题还需要结合各个公司的制度去分析。样品取出后理化项一般要求应在3天内检测完毕，温湿度敏感的检测时间应更短。",
   "position": 1
  },
  {
   "title": "中国药典2020年版稳定性试验指导原则（发行稿见更新）（​9001 原料药物与制剂稳定性试验指导原则）",
   "url": "https://www.lanbeishi.com/%E4%B8%AD%E5%9B%BD%E8%8D%AF%E5%85%B82020%E7%89%88%E7%A8%B3%E5%AE%9A%E6%80%A7%E8%AF%95%E9%AA%8C%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99%E5%BE%81%E6%B1%82%E6%84%8F%E8%A7%81%E7%A8%BF_n87",
   "description": "(二)加速试验\n\n此项试验是在加速条件下进行。其目的是通过加速药物的化学或物理变化，探讨药物的稳定性，为制剂设计、包装、运输、贮存提供必要的资料。供试品要求 3 批，按市售包装，在温度 40℃±2℃、相对湿度 75%±5%的条件下放置 6 个月。所用设备应能控制温度±2℃、相对湿度±5% ，并能对真实温度与湿度进行监测。在试验期间第 1 个月、2 个月、3 个月、6 个月末分别取样一次，按稳定性重点考察项目检测。在上述条件下，如 6 个月内供试品经检测不符合制订的质量标准，则应在中间条件下即在温度 30℃± 2℃、相对湿度 65%±5% 的情况下（可用 Na2CrO4 饱和溶液，30℃，相对湿度 64.8%）进行加速试验，时间至少 12 个月，应包括所有的考察项目，检测至少包含初始和末次的4个时间点（如 0、6、9、12 月）。加速试验，建议采用隔水式电热恒温培养箱(20〜60℃)。箱内放置具有一定相对湿度饱和盐溶液的干燥器，设备应能控制所需温度，且设备内各部分温度应该均匀，并适合长期使用。也可采用恒湿恒温箱或其他适宜设备。 [...] （二）加速试验\n\n此项试验是在加速条件下进行，其目的是通过加速药物制剂的化学或物理变化，探讨药物制剂的稳定性，为处方设计、工艺改进、质量研究、包装改进、运输、贮存提供必要的资料。供试品要求 3 批，按市售包装，在温度 40℃±2℃、相对湿度 75%±5% 的条件下放置 6 个月。所用设备应能控制温度±2℃、相对湿度±5%，并能对真实温度与湿度进行监测。在试验期间第 1 个月、2 个月、3个月、6 个月末分别取样一次，按稳定性重点考察项目检测。在上述条件下，如 6 个月内供试品经检测不符合制订的质量标准，则应在中间条件下即在温度 30℃ ±2℃、相对湿度 65%±5%的情况下进行加速试验，时间至少 12 个月，应包括所有的考察项目，检测至少包含初始和末次的 4 个时间点（如 0、6、9、12 月）。\n\n溶液剂、混悬剂、乳剂、注射液等含有水性介质的制剂可不要求相对湿度。试验所用设备与原料药物相同。\n\n对温度特别敏感的药物制剂，预计只能在冰箱(4〜8℃)内保存使用，此类药物制剂的加速试验，可在温度 25℃±2℃，相对湿度 60% ±10%的条件下进行，时间为 6 个月。 [...] 对拟冷冻贮藏的药物，长期试验可在温度-20℃±5℃的条件下至少放置 12个月。\n\n长期试验采用的温度为 25℃±2℃、相对湿度为 60%±10%，或温度 30℃±2℃、相对湿度 65%±5%，是根据国际气候带制定的。国际气候带见下表。\n\n温带主要有英国、北欧、加拿大、俄罗斯；亚热带有美国、日本、西欧（葡萄牙——希腊）；干热带有伊朗、伊拉克、苏丹；湿热带有巴西、加纳、印度尼西亚、尼加拉瓜、菲律宾。中国总体来说属亚热带，部分地区属湿热带，故长期试验采用温度为 25℃±2℃、相对湿度为 60%±10%，或温度 30℃±2℃、相对湿度65%±5%，与美、日、欧国际协调委员会（ICH）采用条件基本是一致的。\n\n原料药物进行加速试验与长期试验所用包装应采用模拟小桶，但所用材料与封装条件应与大桶一致。\n\n二、药物制剂\n\n药物制剂稳定性研究，首先应查阅原料药物稳定性有关资料，特别了解温度、湿度、光线对原料药物稳定性的影响，并在处方筛选与工艺设计过程中，根据主药与辅料性质，参考原料药物的试验方法，进行影响因素试验、加速试验与长期试验， 符合一定条件可以应用括号法和矩阵法简化试验方案。",
   "position": 2
  },
  {
   "title": "中国药典2020年版四部通则9001关于药物与制剂稳定性试验指导原则_新闻资讯_行业动态_鑫富达医药包装",
   "url": "https://m.xfdyb.com/show-2002.html",
   "description": "(二)加速试验\n\n此项试验是在加速条件下进行，其目的是通过加速药物制剂的化学或物理变化，探讨药物制剂的稳定性，为处方设计、工艺改进.质量研究、包装改进、运输、贮存提供必要的资料。供试品在温度40℃+2℃、相对湿度75%+5%的条件下放置6个月。所用设备应能控制温度+2，相对湿度+5%，并能对真实温度与湿度进行监测。在至少包括初始和未次等的3个时间点(如0、3、6月)取样，按稳定性考察项目检测。如在25℃+2℃、相对湿度60%±5%,条件下进行长期试验,当加速试验6个月中任何时间点的质量发生了显著变化，则应进行中间条件试验。中间条件为30℃+2℃、相对湿度65%+5%，建议的考察时间为12个月，应包括所有的稳定性重点考察项目，检测至少包括初始和末次等的4个时间点(如0、6、9、12月)。溶液剂、混县剂、乳剂、注射液等含有水性介质的制剂可不要求相对湿度，试验所用设备与原料药物相同，\n\n对温度特别敏感的药物制剂，预计只能在冰箱(5℃+3'℃)内保存使用，此类药物制剂的加速试验，可在温度25℃+2℃、相对湿度60%+5%的条件下进行，时间为6个月。 [...] （三）长期试验\n\n长期试验是在接近药品的实际贮存条件下进行，其目的是为制订药品的有效期提供依据。供试品在温度25℃+2℃℃、相对湿度60%+5%的条件下放置12个月，或在温度30℃+2℃、相对湿度65%+5%的条件下放置12个月。至于上述两种条件选择哪一种由研究者确定。每3个月取样一次，分别于0个月、3个月、6个月、9个月、12个月取样，按稳定性重点考察项目进行检测。12个月以后，仍需继续考察的，分别于18个月、24个月、36个月取样进行检测。将结果与0个月比较以确定药品的有效期。由于实测数据的分散性，一股应按95%可信限进行统计分析，得出合理的有效期。如3批统计分析结果差别较小，则取其平均值为有效期限。若差别较大，则取其最短的为有效期。数据表明很稳定的药品，不作统计分析。\n\n对温度特别敏感的药品，长期试验可在温度5℃+3℃的条件下放置12个月，按上述时间要求进行检测，12个月以后，仍需按规定继续考察，制订在低温贮存条件下的有效期。\n\n对拟冷冻贮藏的制剂，长期试验可在温度-20℃+5℃的条件下至少放置12个月，货架期应根据长期试验放置条件下实际时间的数据而定。 [...] 对拟冷冻贮藏的制剂，应对一批样品在5℃+3℃或25°+2℃条件下放置适当的时间进行试验，以了解短期偏离标签贮藏条件(如运输或搬运时)对制剂的影响。\n\n乳剂、混县剂、软膏剂、乳喜剂、糊剂、凝胶剂、眼营剂、栓剂、气剂、泡腾片及泡腾颗粒宜直接采用温度30℃±2℃、相对湿度65%+5%的条件进行试验，其他要求与上述相同。\n\n对于包装在半透性容器中的药物制剂，例如低密度聚乙烯制备的输液袋、塑料安甑、眼用制剂容器等,则应在温度40℃±2℃、相双湿度25%+5%的条件(可用CH:COOK·1.5H,O饱和溶液)进行试验。\n\n（三）长期试验",
   "position": 3
  },
  {
   "title": "中药制剂稳定性研究技术指导原则（试行）",
   "url": "https://www.zjitcm.com/info/details/29/794.html",
   "description": "加速试验一般在40℃±2℃、RH75％±5％条件下进行试验，考察时间为6个月，检测至少包括初始、中间和末次等3个时间点（如：0、3、6月）。根据研发经验，预计加速试验可能会出现明显变化，则应当在试验设计中考虑增加检测时间点。如果在25℃±2℃、RH60%±5%条件下进行长期试验，当加速试验过程中质量发生了明显变化，则应当进行中间条件试验（30℃±2℃、RH65%±5%）。\n\n膏药、胶剂、乳剂、混悬剂、软膏剂、乳膏剂、糊剂、凝胶剂、眼膏剂、栓剂、气雾剂、泡腾片及泡腾颗粒宜直接采用30℃±2℃、RH65%±5%的条件进行试验。\n\n拟冷藏贮藏（5℃±3℃）的制剂的加速试验可在25℃±2℃、RH60％±5％条件下进行，时间为6个月。如果加速试验3个月以内发生明显变化，则不必进行6个月的试验。\n\n对拟冷冻贮藏（-20℃±5℃）的制剂，应当对一批样品在5℃±3℃或25℃±2℃条件下放置适当的时间进行试验，以了解短期偏离标签贮藏条件（如运输或搬运时）对其的影响。\n\n对有特殊温湿度要求的制剂，可制定其他试验温度、湿度。\n\n（三）长期试验 [...] （三）长期试验\n\n长期试验是在接近制剂实际贮藏条件下进行的稳定性试验，为确定制剂的包装、贮藏条件及有效期提供依据。\n\n供试品放置条件通常为25℃±2℃、RH60％±5％或30℃±2℃、RH 65%±5%，考察时间点应当能预测制剂的稳定性情况。一般分别于 0、3、6、9、12、18月取样进行检测，仍需继续考察的，根据产品特性，可分别于24月、36月等取样进行检测。\n\n对有特殊温湿度要求的制剂，可制定其他试验温度、湿度。\n\n四、研究要求与结果评价\n\n（一）研究要求\n\n稳定性研究的内容应当根据注册申请的分类以及药品的具体情况，围绕稳定性研究的目的进行设计和开展工作。原料药物与制剂一同申报的，应当同时提供原料药物的稳定性研究资料。\n\n1.申请临床试验\n\n对于申请临床试验的中药制剂，应当提供符合临床研究要求的稳定性研究资料，初步确定适宜的包装材料和容器、贮藏条件，保证临床试验期间所用样品质量稳定。一般情况下，应当提供影响因素试验、3批样品不少于6个月的加速试验及长期试验资料。\n\n2.申请上市许可 [...] 对于包装在半透性容器（例如低密度聚乙烯、聚丙烯等制备的输液袋、塑料安瓿、眼用制剂容器等）中的中药制剂，其加速试验应当在 40℃±2℃、RH25%±5%的条件下进行试验，长期试验可选择在 25℃±2℃、RH40%±5%或 30℃±2℃、RH35%±5%的条件下进行试验。对采用半透性容器包装的水溶性制剂，在上述稳定性试验中，除评估该制剂的物理、化学、生物学稳定性外，还应当评估其潜在的失水性等相关指标，具体研究参照相关技术指导原则。对于非水或溶剂型基质的药物，可建立其他可比的方法进行试验，并应说明所建方法的合理性。\n\n3.有效期的确定\n\n有效期应当根据加速试验和长期试验的结果分析确定，一般情况下，以长期试验结果为依据，可取长期试验结果与0月数据相比无明显变化的最长时间点为有效期。\n\n（三）稳定性研究承诺及药品上市后的稳定性考察\n\n对于上市许可申请，当申报注册的3个商业规模批次样品的长期稳定性数据已涵盖拟定的有效期时，则认为无需进行批准后的稳定性承诺。当递交的资料包含了至少3个商业规模批次样品的稳定性试验数据，但长期稳定性数据尚未至拟定的有效期，则应当承诺继续进行研究直到拟定的有效期。",
   "position": 4
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  {
   "title": "2015版药典化学药物（原料药和制剂）稳定性研究技术指导 ...",
   "url": "https://www.alit.com.cn/industrydynamics/info_itemid_254.html",
   "description": "长期试验的放置条件通常为25℃±2℃/60%RH±5%RH或30℃±2℃/65%RH±5%RH，考察时间点应能确定原料药的稳定性情况；如建议的有效期（复检期）为12个月以上，检测",
   "position": 5
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  {
   "title": "化学药物稳定性研究技术指导原则",
   "url": "https://baike.baidu.com/item/%E5%8C%96%E5%AD%A6%E8%8D%AF%E7%89%A9%E7%A8%B3%E5%AE%9A%E6%80%A7%E7%A0%94%E7%A9%B6%E6%8A%80%E6%9C%AF%E6%8C%87%E5%AF%BC%E5%8E%9F%E5%88%99/17006120",
   "description": "在对采用不可透过性包装的含有水性介质的制剂，如溶液剂、混悬剂、乳剂、注射液等的稳定性研究中可不要求相对湿度。对采用半通透性的容器包装的药物制剂，如塑料软袋装注射液、塑料瓶装滴眼液、滴鼻液等，加速试验应在 40℃±2℃、RH20%±5%的条件下进行。\n\n乳剂、混悬剂、软膏剂、糊剂、凝胶剂、眼膏剂、栓剂、气雾剂、泡腾片及泡腾颗粒等制剂宜直接采用 30℃±2℃、RH65%±5%的条件进行试验。\n\n对温度敏感药物（需在冰箱中 4-8℃冷藏保存）的加速试验可在 25℃±2℃、RH60%±5%条件下同法进行。需要冷冻保存的药品可不进行加速试验。\n\n长期试验\n\n长期试验是在上市药品规定的贮存条件下进行，目的是考察药品在运输、保存、使用过程中的稳定性，能直接地反映药品稳定性特征，是确定有效期和贮存条件的最终依据。\n\n取三批样品在 25℃±2℃、RH60%±10%条件进行试验，取样时间点在第一年一般为每 3 个月末一次，第二年每 6 个月末一次，以后每年末一次。 [...] 以上为影响因素稳定性研究的一般要求。根据药品的性质必要时可以设计其他试验，如考察 pH 值、氧、低温、冻融等因素对药品稳定性的影响。对于需要溶解或者稀释后使用的药品，如注射用无菌粉末、溶液片剂等，还应考察临床使用条件下的稳定性。\n\n加速试验\n\n加速试验是在超常条件下进行的，目的是通过加快市售包装中药品的化学或物理变化速度来考察药品稳定性，对药品在运输、保存过程中可能会遇到的短暂的超常条件下的稳定性进行模拟考察，并初步预测样品在规定的贮存条件下的长期稳定性。\n\n加速试验一般取拟上市包装的三批样品进行，建议在比长期试验放置温度至少高 15℃的条件下进行。一般可选择 40℃±2℃、RH75%±5%条件下进行 6 个月试验。在试验期间第 0、1、2、3、6 个月末取样检测考察指标。如在 6 个月内供试品经检测不符合质量标准要求或发生显著变化，则应在中间条件 30℃±2℃、RH65%±5%同法进行 6 个月试验。 [...] ①记录温度；②平均热力学温度\n\n在这四种气候带中，对于药品的质量保证而言，条件最苛刻的是第四种气候带，即高温又高湿的环境。中国总体来说属于亚热带，推荐长期试\n\n验采用温度湿度条件为：25℃±2℃，60%RH±10%RH，与 ICH 所采用的条件基本一致。\n\n### 低温和冻融试验\n\n对于易发生相分离、黏度减小、沉淀或聚集的药品需通过低温或冻融试验来验证其运输或使用过程中的稳定性，作为影响因素试验的一部分。具体方法如下：\n\n（1）低温试验应包括三次循环，每次循环应在2～8℃条件下2天，然后在40℃加速条件下考察2天，取样检测。\n\n（2）冻融试验应包括三次循环，每次循环应在-10～-20℃条件下 2 天，然后在 40℃加速条件下考察 2 天，取样检测。\n\n### 研究报告\n\n一般地，稳定性研究部分的申报资料应包括以下内容：\n\n1、供试药品的品名、规格、剂型、批号、生产者、原料药的来源、生产日期和试验开始时间。并应明确给出稳定性考察中各个批次药品的批产量。\n\n2、各稳定性试验的条件，如温度、光照强度、相对湿度、容器等。应明确包装/密封系统的性状，如包材类型、形状和颜色等。",
   "position": 6
  }
 ],
 "中国药典 9001 原料药物与制剂稳定性试验指导原则": [],
 "lyophilized PCR Ct shift acceptance criteria stability": [],
 "freeze dried PCR bead lyobead contract manufacturing CDMO": [
  {
   "title": "LyoBead – ZYMETAS",
   "url": "https://zymetas.com/cdmo/lyobead",
   "description": "Zymetas CDMO offers IVD solutions for LyoBead production that include a bead dispenser, sealable tray, and freeze dryer. The combination provides all the necessary parts to quickly implement using LyoBeads.\n\nSteps for LyoBead Production:\n\nBead Formation => Transfer => Freeze Drying => Storage [...] ZYMETAS\n\n###### ZYMETAS\n\nA proven pioneer and partner to the diagnostics industry\n\nWe are an CDMO-driven company constantly developing new technologies and unique biomarkers with high clinical value. Read more.\n\nLyoBead Production Systems for Freeze Drying\n\n### Pioneers of IVD Solutions for Lyophilized Beads [...] Advantages of LyoBeads\n\nAdvantages of The Vacuum Sealable Tray\n\nWhat are LyoBeads also called?\n\nThere are several other terms for LyoBeads:\n\nZYMETAS\n\n# ZYMETAS\n\nThe best choice in CDMO for IVD materials and expertise.\n\nZymetas designs and develops smart molecular detection assays, in collaboration with different partners. Our strength lies in the qPCR and point-of-care assays with main focus on the detection of pathogens and their antibiotic resistance.\n\n##### Assay R&D\n\n##### ContactS",
   "position": 1
  },
  {
   "title": "Diagnostics Manufacturing",
   "url": "https://btllc.solutions/diagnostics-manufacturing",
   "description": "Biopharma Technology LLC offers contract freeze-drying services for lyocakes. Lyocakes are flat, circular freeze-dried reagents generally dried in situ into a",
   "position": 2
  },
  {
   "title": "LyoBead Production Systems",
   "url": "https://www.millrocktech.com/lyobead",
   "description": "Turn-key lyophilized bead production from Millrock: BeadLab dispenser, sealable tray, and freeze dryer for diagnostic reagents, PCR assays, and enzymes.",
   "position": 3
  },
  {
   "title": "How are lyo beads manufactured?",
   "url": "https://www.biofortuna.com/how-are-lyo-beads-manufactured",
   "description": "Lyo beads are durable spheres of freeze-dried material formed from accurately measured and dispensed volumes of customisable formulation.",
   "position": 4
  },
  {
   "title": "Lyobeads Contract Development",
   "url": "https://www.evikdiagnostics.com/development",
   "description": "Partner with Evik Diagnostics for your lyophilized bead assay development. Our team delivers creative solutions for your most demanding project",
   "position": 5
  },
  {
   "title": "Why use lyobeads technology for diagnostics production?",
   "url": "https://www.youtube.com/watch?v=KT8BOpQANJs",
   "description": "Using lyobead technology rather than conventional freeze drying methods has many benefits for fast turnaround projects such as diagnostics.",
   "position": 6
  }
 ],
 "trehalose Tg' collapse temperature sucrose mannitol freeze drying values": [
  {
   "title": "Detection of Collapse and Crystallization of Saccharide, Protein, and Mannitol Formulations by Optical Fibers in Lyophilization",
   "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5790775",
   "description": "at 1°C/min. For both sucrose and trehalose solutions, the Tg' shifted to higher values with increasing heating rates in DSC. In contrast, the T OFS peak did not shift between 0.5 and 2.5°C/min (Table 2). The highest DSC heating rate of 10°C/min could not be applied in the OFS setup in the freeze-dryer. In subsequent experiments, 1°C/min was used as default. [...] First, it was to be proven whether the T OFS peak at around −30°C resulted from the glass transition and was not an artifact. Therefore, several excipients with different Tg' values were investigated. The two commonly used disaccharides sucrose and trehalose both showed Tg' and T OFS values of around −32 to −28°C (Figure 3). Stachyose, a rarely used tetrasaccharid, showed a Tg' value of −23.8 ± 0.2°C and a T OFS peak at −23.8 ± 0.4°C. Due to the shift of both, the Tg' value and the T OFS peak, [...] Typical parameters of amorphous matrices, as formed by the most frequently used saccharides for stabilization of proteins, sucrose and trehalose, are the collapse temperature (Tc) and the glass transition temperature (Tg') of the freeze-concentrated solution (Meister and Gieseler, 2009; Pansare and Patel, 2016). They characterize temperatures at which the mobility of the system greatly increases, either at the drying front (Tc) or in the frozen state (Tg'). Tc is typically determined by",
   "position": 1
  },
  {
   "title": "Full article: Effects of drying methods on physical properties and morphology of trehalose/mannitol mixtures",
   "url": "https://www.tandfonline.com/doi/full/10.1080/07373937.2022.2103564",
   "description": "Tg’ of the frozen systems has also been determined using DSC. The results are shown in Table 5 and displayed a falling trend from −39 °C for neat trehalose to −54 °C for neat mannitol. Litterature data on Tg’ trehalose-water varies between −40 and −30 °C,[Citation 20] whilst litterature values on Tg’ mannitol-water varies between −27 and −35 °C.[Citation 12,Citation 18] This article presents Tg’-value of mannitol-water system at −54 °C, see supporting information S4.\n\n## Discussion [...] ranged from 36 to 90 °C, whilst Tg2 demonstrated values in the spectrum of 82–110 °C. Spray dried mixtures only exhibited Tg1 values. The mannitol melting enthalpy values (ΔH m) typically increased with more mannitol in the mixtures. Typically, DSC thermograms of mannitol showed one sharp and narrow peak in the range of 135–167 °C. Some of the thermograms demonstrated two peaks alternatively hinted two peaks, mainly freeze-dried, and annealed freeze-dried 50/50 and 25/75, whilst other showed [...] The study is focused on a combination of trehalose and mannitol. Dry trehalose has a high Tg, different measurements range between 100 and 130 °C,[Citation 22] here is a Tg of dry trehalose of 117 °C, from Drake et al[Citation 23] used as a representative value of the literature. The Tg of dry mannitol is lower, a Tg of 13 °C has been reported.[Citation 18]",
   "position": 2
  },
  {
   "title": "Crystallization of Trehalose in Frozen Solutions and its Phase Behavior during Drying",
   "url": "https://www.academia.edu/32719942/Crystallization_of_Trehalose_in_Frozen_Solutions_and_its_Phase_Behavior_during_Drying",
   "description": "The effects of trehalose and sucrose on the rate of ice crystal growth in ice cream during accelerated shelf-life were compared. Experimental and theoretical freezing curves were shown to be in good agreement. Glass transition temperatures (T g) of maximally freeze concentrated trehalose and sucrose solutions (40% w ⁄ w) were found to be)39.5°C and)47°C respectively. For ice cream mixes, the T g value increased from)46.4°C for the 100% sucrose-based mix to)42.0°C for the 100% trehalose [...] recovery were determined in the final heating scan. Frozen unannealed trehalose solutions were characterized by two glass transition events. At a heating rate of 2 • C/min, the observed Tg 1 and Tg 2 were ∼−45 and −31 • C, respectively. Annealing resulted in an increase in the lower transition temperature, Tg 1 , while the higher transition temperature, Tg 2 , was unaffected. Enthalpic recovery due to annealing was associated only with Tg 2. Annealing at −36 • C resulted in the highest value of [...] of trehalose in the presence of (i) a crystallizing (mannitol), (ii) a non-crystallizing (sucrose) solute and (iii) a combination of mannitol and a model protein (lactose dehydrogenase, catalase, or lysozyme) was evaluated. By performing the entire freeze-drying cycle in the sample chamber of the XRD, the phase behavior of trehalose and mannitol were simultaneously monitored. Results When an aqueous solution containing trehalose (4% w/v) and mannitol (2% w/v) was cooled to −40°C at 0.5°C/min,",
   "position": 3
  },
  {
   "title": "Lyoprotective Effects of Mannitol and Lactose Compared to ...",
   "url": "https://www.mdpi.com/1999-4923/13/8/1164/review_report",
   "description": "Tg values of additives (manitol, Te = -2o. T ́g = -28oC; sucrose, T ́g= -30o C; trehalose, T ́g = -28oC … immediately did melt-collapsed at room temperature.",
   "position": 4
  },
  {
   "title": "Glass transition temperatures of amorphous, freeze-dried...",
   "url": "https://www.researchgate.net/figure/Glass-transition-temperatures-of-amorphous-freeze-dried-sucrose-trehalose-mixtures-at_fig7_249017475",
   "description": "Based on previously reported data, these values are about 8 or 9 °C less than what was expected for those sugars ( ∼ 115 °C for trehalose and 70 °C for sucrose",
   "position": 5
  },
  {
   "title": "Freeze-Drying Protein Formulations above their Collapse ...",
   "url": "https://www.americanpharmaceuticalreview.com/Featured-Articles/37021-Freeze-Drying-Protein-Formulations-above-their-Collapse-Temperatures-Possible-Issues-and-Concerns",
   "description": "pores where the crystals of pure ice had been. The traditional approach to the design of a lyo cycle is to maintain this completely or partially amorphous phase in a glassy state during primary drying which involves keeping the temperature of the newly freeze-dried material below Tg’, the glass-rubber transition temperature of the amorphous phase which still contains about 20% water. For sucrose-based formulations Tg’ is -34°C to -25°C depending on the protein content  Above this temperature [...] In two other studies, however, some decrease in long term stability was observed. One study found some decrease in the antigenic activity of toxins was observed six months after undergoing an aggressive freeze-drying cycle whether stored at 5° or 25°C . Another study  found a decrease in stability of collapsed sucrose-glycine cakes relative to uncollapsed cakes but the collapsed cakes all had elevated moisture levels. A decrease in stability was seen in all cakes with elevated moisture whether [...] However, it has been demonstrated that there can be a situation, referred to as microcollapse, in which the basic pore structure of the dry layer remains intact even though the product temperature is well above Tg’ during primary drying and the amorphous phase is subject to some viscous flow. If there is loss of the pore structure, that would then be referred to as “macrocollapse” . There are two basic ways of controlling the degree of collapse:",
   "position": 6
  }
 ],
 "冻干 试剂 残留水分 卡尔费休 限度 3%": [
  {
   "title": "冻干粉含水量检测：基于德国默克（Merck）卡尔费休试剂的方法",
   "url": "http://m.secomam.net/apollo/jsshow-490907.html",
   "description": "选择建议：冻干粉含水量通常极低（常用范围0.1%~5%），若含水量＜1%，优先选用库仑法试剂，精度可达ppm级；若含水量＞1%或样品量充足，可选用容量法试剂。",
   "position": 1
  },
  {
   "title": "卡氏水分仪在冻干粉针剂水分控制与FDA合规性解读",
   "url": "http://www.klfxyq.com/Article-4487689.html",
   "description": "冻干粉针剂残留水分是影响产品货架质量与海外申报合规的核心指标，卡尔- 费休库仑法凭借微量检测能力，适配冻干制剂低水分检测场景。KLS201 微量水分测定",
   "position": 2
  },
  {
   "title": "冻干微球试剂的水分检测-卡尔费休水分测定仪联用卡氏加热炉",
   "url": "https://zhuanlan.zhihu.com/p/615694237",
   "description": "微球冻干试剂是一种常见的诊断试剂，但是样品水分检测却比较麻烦，用卡尔费休法之间检测，样品在有机溶剂中溶解性不好，测出来没有重现性，用传统的烘",
   "position": 3
  },
  {
   "title": "卡尔·费歇尔试剂",
   "url": "https://www.sigmaaldrich.com/HK/zh/products/analytical-chemistry/analytical-reagents/karl-fischer-reagents",
   "description": "容积法卡尔·费歇尔滴定法通过向样品中加入含碘滴定剂，可精确测定水分含量。样品需溶解于适当的溶剂中，以彻底释放水分。该方法可测定0.01% 至100% 的水分含量，并能快速",
   "position": 4
  },
  {
   "title": "水分测定——卡尔费休滴定法VS近红外光谱法 | Metrohm",
   "url": "https://www.metrohm.com/zh_cn/discover/blog/20-21/moisture-analysis---karl-fischer-titration--nirs--or-both-.html",
   "description": "重定向消息\n\n瑞士万通公司Logo\n\n 400-604-0088\n 获取报价\n zh\n\n# 水分测定——卡尔费休滴定法VS近红外光谱法\n\nWater content, moisture analysis, and moisture quantification with Karl Fischer titration and near-infrared spectroscopy.\n\n#### 除了pH值的测定、称量和酸碱滴定外，水分测定也是世界各地实验室中经常测定的项目之一。水分测定几乎对每个行业都很重要，例如：润滑油、食品、饲料和制药。\n\n图 1.   蜘蛛网上的水滴\n\n对于润滑油来说，了解水分含量是非常重要的，因为过量的水分会加速机器的磨损。对于食品和饲料，水分含量须控制在一个很小的范围内，这样食品吃起来才不会干或不新鲜，也不会因为滋生细菌和真菌而导致腐败。对于药品，要密切监测固体剂型（片剂）和冻干产品中的水分含量，相关法规规定其含水量需低于2%。\n\n图 2.   容量法卡尔费休滴定中手动进样\n\n### 卡尔费休滴定法 [...] 具体流程如图5所示。\n\n图 5. 使用近红外光谱法进行水分分析的工作流程\n\n创建校准集需要使用近红外光谱法和卡尔费休滴定法共同测定大约30-50个样品，并把卡尔费休滴定法测得结果值与近红外光谱相关联。接下来的步骤是模型开发和验证（图5中的步骤2和3），这对于水分分析非常简单。水是一种很强的近红外吸收剂，其峰值总是在1900-2000nm（合频）和1400-1550nm（一次倍频）。如下图6所示。\n\n图6. 保湿霜的近红外光谱，显示在1400-1550nm和1900-2000nm处与H2O相关的吸收\n\n在建立和验证完预测模型后，近红外光谱即可用于该物质的常规水分测定。水分含量的测定结果将在1分钟内获得，无需任何样品前处理，也无需使用任何化学品。此外，分析人员不必是化学专业人士，因为他们只需在仪器上放置样品，然后按开始键。\n\n通过下载我们下列免费应用报告，您可获得关于近红外光谱测定聚酰胺、己内酰胺、冻干产品、肥料、润滑油和乙醇/烃类混合物中水分的更多信息。\n\nAN-NIR-060：聚酰胺\n\nAN-NIR-077：己内酰胺\n\nAN-NIR-078：冻干产品\n\nAN-NIR-079：肥料 [...] ### 卡尔费休滴定法\n\n卡尔费休滴定水分测定法早在20世纪30年代就被引入，时至今日仍然是十分可靠的水分测定方法之一。它是一种快速且专一的方法，这意味着测定的只有水。卡尔费休滴定是基于以下两个氧化还原反应。\n\n在步骤一反应中，甲醇和二氧化硫反应生成相应的酯。在碘的加入下，酯在耗水反应中被氧化成硫酸盐。当水耗尽时，反应就结束了。\n\n图 3.   使用瑞士万通874卡氏加热炉样品处理器全自动进行卡尔费休滴定\n\n尔费休滴定可用于测定各种类型样品（液体、固体、浆料、甚至气体）中的水含量。对于水含量在0.1%-100%的样品，可以使用容量法卡尔费休滴定；而对于水含量在0.001%-1%的样品，推荐使用库仑法卡尔费休滴定。\n\n根据样品类型、水分含量以及在卡尔费休试剂中的溶解度，样品可以直接添加到滴定杯或先用合适的溶剂溶解后再添加。合适的溶剂是指不与卡尔费休试剂反应的溶剂，因此可以排除醛和酮。如果样品溶解在溶剂中，还需要用纯溶剂进行空白校正。测量时，使用注射器和针头将样品直接注入滴定杯中（图2）。终点由极化的双铂针电极进行检测，并由此直接计算出水含量。",
   "position": 5
  },
  {
   "title": "卡尔费休滴定法——水分分析",
   "url": "https://sgsystemsglobal.com/zh-CN/%E8%AF%8D%E6%B1%87%E8%A1%A8/%E5%8D%A1%E5%B0%94%E8%B4%B9%E4%BC%91%E6%BB%B4%E5%AE%9A%E6%B3%95%E6%B0%B4%E5%88%86%E5%88%86%E6%9E%90",
   "description": "主要有两种测定方式。容量法卡尔费休滴定法（KF）使用已知浓度的碘试剂滴定微克至毫克级的水分含量（约0.1%–100%水分，1–100 mg H₂O ）。库仑法卡尔费休滴定法通过电化学方法原位生成碘，适用于低浓度水分测定（通常为1 µg–10 mg，在合适的基质中可低至个位数ppm）。各种附件——例如带顶空转移功能的烘箱式卡尔费休滴定仪、油模块、均质器和自动进样器——可将卡尔费休滴定法的应用范围从粉末和颗粒扩展到粘稠糖浆、聚合物、冻干饼和疏水性基质。当按照ALCOA+规范执行并具备审计追踪功能时，卡尔费休滴定法便成为一个高通量、可随时接受检验的水分测定平台。\n\n> “如果说干燥失重法告诉你水分蒸发了，那么卡尔·费舍尔法就能准确地告诉你水分的含量——快速、有选择性且可靠。”\n\nTL; DR： KF 使用碘-SO2 化学与水发生化学计量反应。选择 容积 对于更高的负载和 库仑法 检测微量水分。控制泄漏、漂移和试剂因素；使用炉卡尔费休去除水分，避免基质干扰。锁定方法 文件控制，验证准确性/精密度/稳健性，并将读数直接捕获到 基础代谢率/错配修复缺陷 使用校准的设备和 双重验证 进行编辑。 [...] 容量法卡尔·费休滴定法。滴定管分配已知浓度的含碘滴定剂（例如，2–5 mg H₂O / mL）。该方法适用于含水量为 0.1%–100% 的样品，固体样品量约为 10–200 mg，液体样品量约为 0.1–5 mL。关键变量包括滴定剂因子（以水标准溶液进行标准化）、样品溶解或萃取完全度、漂移扣除以及终点稳定性。容量法尤其适用于含水量高的样品，例如水合盐、糖浆、湿颗粒、植物提取物等，而库仑法在这些情况下会达到饱和。\n\n库仑法卡尔费休法 (KF)。碘在阳极电化学生成；通过的电荷量与水的摩尔数直接相关（法拉第定律）。使用灵敏的样品池和隔膜或无隔膜设计，库仑法可以定量分析 1 µg 至数毫克的水，在控制背景干扰的情况下，可实现个位数 ppm 的测量精度。它是小瓶、安瓿瓶、聚合物、冻干材料和高纯度溶剂分析的首选方法。将样品池预处理至低漂移（<5–10 µg/min）并防止泄漏是实现精确痕量分析的关键。 [...] 回收率明显为负值或结果偏低。根本原因：溶解不完全、基质中残留水分、烘箱温度过低。解决方法：更换溶剂混合物、提高烘箱温度（已验证）、延长保温时间、将样品粉碎或用合适的溶剂预润湿。\n\n正偏差（过高）。根本原因：羰基化合物/胺类干扰、氧化剂/还原剂、乙醇/湿溶剂、称量过程中空气中的水分。解决方法：使用抗酮试剂、衍生化溶剂、改进烘箱转移、加快取样速度、加强环境控制。\n\n失控因素。根本原因：操作规范不规范、注射器错发、温度影响。解决方法：重新培训微量添加操作、校准注射器、平衡标准溶液、使用带有可追溯证书的密封安瓿瓶。\n\n仪器间结果不一致。根本原因：不同的样品池类型/溶剂、不一致的烘箱程序、校准间隙。解决方法：统一方法、使用共享标准品进行交叉验证、协调维护计划，并在质量管理体系 ( QMS ) 下开展对比研究。\n\n## 9）这与V5如何契合",
   "position": 6
  }
 ],
 "lyophilized diagnostic reagent residual moisture specification WHO": [
  {
   "title": "Residual Moisture Testing Methods for Lyophilized Drug Products",
   "url": "https://www.pharmtech.com/view/residual-moisture-testing-methods-lyophilized-drug-products",
   "description": "Lyophilization is a way to preserve products that are unstable in the presence of water. Removing the water from the product decreases the potential for degradation by hydrolysis and, therefore, improves the product’s shelf life. Residual moisture content is a CQA of lyophilized finished products. According to the International Council for Harmonization (ICH) Q6A guidance, the water content of a finished product should have a test procedure and a specification when appropriate (1). [...] Karl Fischer titration method.Karl Fischer titration is one of the most widely used analytical methods for residual moisture determination for lyophilized products (7,8). The method is suitable for a variety of dry products and, depending upon the amount of moisture to be measured, has multiple options for the best applicable method. Direct volumetric dispensing of the reagent is suitable for materials that have a relatively high level of residual moisture content in the range of 25–250 mg of [...] of 25–250 mg of water present in the sample. Lyophilized products typically have a low level of residual moisture content; a more sensitive method is warranted.",
   "position": 1
  },
  {
   "title": "Residual Moisture Testing for Lyophilized Drugs | Leukocare",
   "url": "https://www.leukocare.com/blog/residual-moisture-testing-for-lyophilized-drugs",
   "description": "For most lyophilized biologics, the target residual moisture level is between 1% and 3%. This is not a universal rule.\n\n Too much moisture: Can accelerate hydrolysis and lead to aggregation, compromising product safety and efficacy.[12, 4, 9]\n Too little moisture (over-drying): Can also be bad, potentially denaturing the protein by removing the essential water molecules required for structural integrity, leading to aggregation and loss of activity.[12, 4, 9] [...] The output is not just a stable product; it is a comprehensive, IND-ready data package. This includes a robust formulation, a validated and efficient lyophilization process, and a clear scientific justification for your residual moisture specification. This level of process understanding provides confidence for regulatory submissions and cuts down on questions from health authorities. After switching to a predictive formulation platform, one of our partners stabilized their lead AAV candidate [...] Residual moisture is a key quality attribute (CQA) for lyophilized products, directly influencing their physical and chemical stability. It acts as a plasticizer, lowering the glass transition temperature (Tg) of the formulation. When storage temperature exceeds the Tg, molecular mobility increases, accelerating degradation pathways like aggregation and deamidation.[13, 14, 7]",
   "position": 2
  },
  {
   "title": "Determining the residual moisture in lyophilized protein ...",
   "url": "https://www.researchgate.net/publication/21563906_Determining_the_residual_moisture_in_lyophilized_protein_pharmaceuticals",
   "description": "Studies indicate that an optimal residual moisture content range of 2% to 3% is ideal for lyophilized mAbs, as excessive drying can negatively affect protein",
   "position": 3
  },
  {
   "title": "Residual Moisture Content in Lyophilized Drugs",
   "url": "https://www.lyophilizationworld.com/post/residual-moisture-content-in-lyophilized-drugs",
   "description": "Residual moisture is a critical parameter for stability of the API in lyophilized drug products, and well-known quality attribute (CQA) of lyophilized drug. The amount of residual moisture content is related to the stability of the formulation over the shelflife of the product. The traditional methods that are used to measure residual moisture are generally destructive and low throughput. As a result, there is a significant interest in non-destructive testing of residual moisture as part of [...] To determine the residual moisture content then is critical and a number of methods have been used including:\n\n1. Karl Fischer Titration\n2. Thermogravimetric Analysis\n3. Near Infra-red Spectroscopy\n4. Headspace Moisture Analysis [...] 2. Thermogravimetric analysis is widely used to determine the weight loss associated with the heating event to drive off the residual moisture. This method measures not only the water but also any other volatiles that are produced as a result of heating. Therefore, the composition of the lyophilized material must be well understood for this method to be used to accurately measure the residual water content. This method also suffers from potential artifacts due to environmental moisture and is",
   "position": 4
  },
  {
   "title": "Analytical Options for the Measurement of Residual Moisture Content in Lyophilized Biological Materials  | American Pharmaceutical Review - The Review of American Pharmaceutical Business & Technology",
   "url": "https://www.americanpharmaceuticalreview.com/Featured-Articles/116129-Analytical-Options-for-the-Measurement-of-Residual-Moisture-Content-in-Lyophilized-Biological-Materials",
   "description": "Lyophilized excipient in vials were opened to atmospheric air and allowed to equilibrate for different time lengths to increase the residual moisture content. The restoppered vials were then held and assayed by NIR and when stable over time moisture was confirmed in typical vials by coulometric Karl Fischer. This approach has been used recently at NIBSC to determine the moisture content in live virus reference materials under development as working standards for clinical diagnostictesting [...] One crucial area of quality control for such biological products then is the measurement of the residual water content of the lyophilized material [4,5,6]. As higher moisture content often correlates with poorer stability, this has resulted in recommendations for low residual moisture content of 0.5-3% w/w  and moisture induced instability is particularly an issue when preparing primary biological reference materials as these must maintain their potency for the life of the standard  although [...] With the increasing number of preparations which have a low dry weight of non-volatile materials (of 10mg/ml filled or less) the impact of dry weight on moisture content determination has been evaluated. A series of two model freeze dried compounds (trehalose and human serum albumin) were prepared and residual moisture determined for dry weights from 50mg/ml to 1mg/ml. The apparent residual moisture rose exponentially below 10 mg and this may be an indication of the limit of detection of the",
   "position": 5
  },
  {
   "title": "LIGHTHOUSE | Moisture Determination",
   "url": "https://lighthouseinstruments.com/applications/moisture-determination",
   "description": "Controlling residual moisture is key in ensuring the quality and shelf life of lyophilized drugs, sterile powders, and solid dosage forms. Inspect 100% of your products using non-destructive headspace moisture analysis, to give you full data-driven insight into process efficiency and consistency.\n\n### LIGHTHOUSE headspace moisture analysis enables [...] Prevent product degradation caused by moisture\n Can your drying process be more efficient?\n Make sure only high-quality product is released to the market\n\nLIGHTHOUSE Headspace Moisture Pressure Analyzer for lyophilized products\n\n### We help you select the best primary package [...] Traditional residual moisture analysis methods are destructive, slow, and unable to measure unbound or reactive water directly. LIGHTHOUSE offers fast, non-destructive headspace moisture analysis that measures reactive water directly, providing accurate, reliable, and more relevant data.\n\nDiscover our non-destructive moisture analyzer\n\n### Topics on this page",
   "position": 6
  }
 ],
 "铝箔袋 干燥剂 湿度指示卡 冻干试剂 包装 常温运输 验证": [
  {
   "title": "干燥剂_湿度卡_脱氧保鲜_复合包装袋_食品用纹路袋",
   "url": "https://www.topcod.com.cn/product/%E5%8C%85%E8%A3%85%E8%A2%8B%E7%B3%BB%E5%88%97-43",
   "description": "佛山市顺德区特普高实业有限公司专业生产各类干燥剂,车灯干燥剂,货柜干燥剂,食品保鲜袋,湿度卡,铝箔袋,屏蔽袋,药品干燥剂,无钴无卤湿度卡,干燥剂包装纸等防潮防锈相关",
   "position": 1
  },
  {
   "title": "工业用铝箔袋基础知识",
   "url": "https://www.betpak.com.cn/news-5/7.html",
   "description": "铝箔袋包装通常指的是铝塑复合真空包装袋，此类产品适用于大型精密机械设备、化学原料、医药中间体的防潮、避光、真空包装。多采用四层结构，具有良好的隔水、隔氧功能。不 ...Read more",
   "position": 2
  },
  {
   "title": "江苏亨瑞生物医药科技有限公司重组人源化胶原蛋白生产 ...",
   "url": "http://www.taizhou.gov.cn/cms_files/filemanager/1558491259/attach/202311/2191df4b801d4331adeec21f1d6bea9c.pdf?fileName=%E6%B1%9F%E8%8B%8F%E4%BA%A8%E7%91%9E%E7%94%9F%E7%89%A9%E5%8C%BB%E8%8D%AF%E7%A7%91%E6%8A%80%E6%9C%89%E9%99%90%E5%85%AC%E5%8F%B8%E9%87%8D%E7%BB%84%E4%BA%BA%E6%BA%90%E5%8C%96%E8%83%B6%E5%8E%9F%E8%9B%8B%E7%99%BD%E7%94%9F%E4%BA%A7%E9%A1%B9%E7%9B%AE%E7%8E%AF%E8%AF%84%E6%8A%A5%E5%91%8A%E5%85%A8%E6%9C%AC%E5%85%AC%E7%A4%BA%E7%89%88.pdf",
   "description": "甘 油、卡波姆均聚物B 型、三乙醇胺、纯化水和水刺无纺布组成，封装在铝箔袋 中，为敷贴型式，产品经钴60 辐照灭菌，无菌形式提供，用于非慢性创面（如 浅表性创面、小创口、擦伤、Ⅰ度或浅Ⅱ度的烧烫伤创面、激光/光子/果酸焕肤/ 江苏亨瑞生物医药科技有限公司重组人源化胶原蛋白生产项目环境影响报告书 2 微整形术后创面）的护理，为创面愈合提供微环境。重组人源化胶原蛋白冻干粉 和重组人源化胶原蛋白预充针适用于面部真皮组织填充以纠正额部动力性皱纹 （包括眉间纹、额头纹和鱼尾纹）。 目前， 重组胶原蛋白已越来越多地受到人们的重视。 相关机构预计， 到2027 年，我国重组胶原蛋白市场规模将达到1083 亿元，其市场前景十分广阔。 根据江苏亨瑞生物医药科技有限公司战略发展规划和市场需求， 江苏亨瑞生 物医药科技有限公司经泰州医药高新技术产业开发区管理委员会备案同意 （备案 号：泰高新发改备〔2021〕117 号），拟投资5000 万元在泰州医药高新技术产 业园区秀水路20 号六期标准厂房区22 幢标准厂房租用三层和四层标准厂房建筑 面积共计4499.04 m2，采购主要仪器设备126 [...] 万瓶 项目 一阶 段正 常运 行 2 排污许可登记，登记号：91321291MA209203X1001Z，有效期限至2026 年1 月19 日 人体胶原蛋白是人体体内物质，分为I 型、Ⅱ型、III 型、IV 型等等，美妆 或者美容护理相关的胶原是III 型胶原蛋白，它主要分布在婴儿皮肤、子宫壁、 血管壁等地方， 能增加皮肤弹性和促进皮肤修复再生， 会随着人的年龄增长流失。 重组人源胶原蛋白是由DNA 重组技术制备的人胶原蛋白特定型别基因编码的全 长或部分氨基酸序列片段， 或是含人胶原蛋白功能片段的组合； 它是采用大肠杆 菌表达系统，利用生物发酵技术实现可规模化生产的一种胶原蛋白，具有与人 100%同源，水溶性强、生物活性高、透皮吸收率高等特点。 重组人源化胶原蛋白创面凝胶由重组Ⅲ型人源化胶原蛋白、 甘油、卡波姆C 型、三乙醇胺、纯化水组成，为凝胶型式，一次性使用，产品经钴60 辐照灭菌， 无菌形式提供， 用于吸收创面渗出液或向创面排出水分， 用于手术后缝合创面等 非慢性创面的覆盖。 重组胶原蛋白创面敷贴由重组Ⅲ型人源化胶原蛋白原液、 甘 油、卡波姆均聚物B [...] m2，采购主要仪器设备126 台（套）建设重组人源化胶原蛋白 生产项目。项目建成后，形成年产重组人源化胶原蛋白冻干粉600 万支、重组人 源化胶原蛋白预充针600 万支、 重组人源化胶原蛋白敷料400 万片、 重组人源化 胶原蛋白凝胶400 万瓶的生产能力。 1.2 项目特点 根据建设单位提供相关资料分析，项目主要特点如下： 1、 项目为改扩建项目， 建设地点位于医药产业园区六期标准厂房区22 幢标 准厂房三层和四层，为建设单位预留区域，项目不新增用地。同时项目原辅料仓 库、危废暂存间等依托现有设施，但废气处理设施等为新建，污水处理装置建成 后本项目及现有项目综合废水均进该污水处理装置进行处理。 2、项目生产的产品为二类和三类医疗器械，但项目涉及重组人源化胶原蛋 白原液生产，原液生产属于生物制品范畴，因此项目生产车间根据GMP 要求设 置不同的功能区、洁净度，各区域和功能间以洁净走廊相连，严格按人流物流分 开原则进行设计；所在车间完全符合GMP 要求，达到国内先进水平。 3、项目生产分为重组人源化胶原蛋白原液和成品生产两部分。原液生产主 要是采用大肠杆菌表达系统，",
   "position": 3
  },
  {
   "title": "药品生产验证指南 | PDF",
   "url": "https://www.scribd.com/document/747774043/%E8%8D%AF%E5%93%81%E7%94%9F%E4%BA%A7%E9%AA%8C%E8%AF%81%E6%8C%87%E5%8D%97",
   "description": "Scribd\n\n# 药品生产验证指南\n\n药品生产验证指南\n\n## Uploaded by\n\n# 药品生产验证指南\n\n# 药品生产验证指南\n\n药品生产验证指南\n\n## Uploaded by\n\n## Share this document\n\n## Footer menu\n\n## About\n\n## Support\n\n## Legal\n\n## Social\n\n## Get our free apps\n\nScribd - Download on the App Store\nScribd - Get it on Google Play\n\n## About\n\n## Legal\n\n## Support\n\n## Social\n\n## Get our free apps\n\nScribd - Download on the App Store\nScribd - Get it on Google Play",
   "position": 4
  },
  {
   "title": "產品型號(714)",
   "url": "https://www.metrohm.com/zh_tw/search.html?start=2200&rows=10&cat=product",
   "description": "止汗剂中铝和锆的测定. 止汗剂中铝和锆的测定. 本应用报告介绍了一种补充方法，可在样品制备（消化）后，使用光学传感器和二甲酚橙指示剂在一个烧杯中连续测定这两种金属 ...Read more",
   "position": 5
  },
  {
   "title": "分析试剂、特种化学品、实验耗材、安全防护、仪器设备",
   "url": "https://www.tansoole.com/upload/detail/01/24KY_AA20_01021442.html",
   "description": "探索编号：. 01021442 · 原始编号：. 3547534A · 分子式：. (CF 3SO 3) 3Dy · MDL号：. MFCD00209583 · CAS号：. 139177-62-1 · 品牌：. Adamas · 分子量：. 609.71 · 等级：. RG.Read more",
   "position": 6
  }
 ],
 "Argonaut BioDot lyophilization beads IVD contract manufacturing": [
  {
   "title": "IVD Contract Manufacturing",
   "url": "https://www.youtube.com/watch?v=6VQyactd-uc",
   "description": "Argonaut is a world-class leader in lyophilization technology. Featuring cake, powder and beads. We also have the world's smallest",
   "position": 1
  },
  {
   "title": "Argonaut Manufacturing Services, Inc. | MTEC",
   "url": "https://mtec-sc.org/life-sciences/argonaut-manufacturing-services-inc",
   "description": "Argonaut Manufacturing Services is a full-service contract manufacturing organization (CMO) dedicated to providing high-quality, innovative, and efficient manufacturing solutions for the pharmaceutical, life sciences, diagnostics, and IVD industries. With decades of industry experience, state-of-the-art facilities, and a focus on quality and regulatory compliance, Argonaut supports clients from early development through commercial production, offering services such as aseptic fill & finish, [...] Feasibility studies, excipient selection, optimization and production-scale lyophilization for vials, powders, beads and small-format reagent dots with packaging and distribution support; excludes pharmaceutical injectable lyophilization for drug substance.\n\n### Life Sciences & IVD Manufacturing\n\nEnd-to-end manufacturing for POCT, IVD and RUO kits including formulation, cartridge/tube/chip filling, kitting, packaging, sterilization coordination and custom QC/QA for global distribution. [...] ## Expertise Areas\n\n Aseptic fill and finish for clinical and commercial drug products\n Formulation and single-use formulation systems for clinical/commercial doses\n Lyophilization and development of unit-dose reagent formats\n IVD, POCT and life-science kit manufacturing and kitting",
   "position": 2
  },
  {
   "title": "Transforming Diagnostic Device Development with LyoDots",
   "url": "https://www.argonautms.com/blog/diagnostic-device-development-lyodots",
   "description": "LyoDots are based on proprietary Argonaut lyophilization technologies and are provided as a lyophilization service. ... Contract Manufacturing Done Right.",
   "position": 3
  },
  {
   "title": "Akoya & Argonaut Expand Partnership for IVD Development | Contract Pharma",
   "url": "https://www.contractpharma.com/breaking-news/akoya-argonaut-expand-partnership-for-ivd-development",
   "description": "# Akoya & Argonaut Expand Partnership for IVD Development\n\nAkoya selects Argonaut as its IVD manufacturing partner.\n\nJanuary 28, 2025\n\nJanuary 28, 2025\n\nAuthor Image\n\nBy: Charlie Sternberg\n\nArgonaut Manufacturing Services, a contract development and manufacturing organization serving the biopharma and life sciences industries, has been selected as the manufacturing partner for Akoya Biosciences Inc.’s IVD assays currently in development. [...] Argonaut Manufacturing Services, a contract development and manufacturing organization serving the biopharma and life sciences industries, has been selected as the manufacturing partner for Akoya Biosciences Inc.’s IVD assays currently in development. [...] “Our spatial phenotyping technology and PhenoImager platform are demonstrating robust diagnostic capabilities for patient selection,” commented Brian McKelligon, CEO of Akoya. “Our partnership with Argonaut is centered around delivering high-quality IVD products to our clients, manufactured under strict cGMP and ISO 13485:2016 requirements. Argonaut’s deep expertise and reliable systems make them an invaluable partner as we scale to meet the demand of the market.”",
   "position": 4
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  {
   "title": "Life Sciences & IVD Contract Manufacturing Service",
   "url": "https://www.argonautms.com/ivd-manufacturing",
   "description": "After evaluating these factors, if you find that outsourcing manufacturing of your IVD, POCT or RUO product offers significant advantages in terms of cost savings, flexibility, risk mitigation, and faster time to market, it may be the right choice for your company. Partnering with a reputable CDMO like Argonaut can provide the support and expertise you need to successfully manufacture your biotech products while allowing your company to focus on its core competencies. [...] While transferring a product already in production to a CDMO can present challenges, such as tech transfer complexities and potential manufacturing disruptions, the benefits can outweigh the drawbacks. By carefully considering the reasons for transferring life science or IVD manufacturing and selecting a reputable CDMO like Argonaut, companies can gain additional capacity, cost optimization, and access to specialized expertise while focusing on their core competencies. [...] Plan for contingencies: Develop contingency plans for potential risks, such as supply chain disruptions, production delays, or regulatory changes. This can help you respond more effectively to unexpected challenges and minimize their impact.\n\nBy following these steps and working closely with a reputable CDMO like Argonaut, you can establish a successful partnership that supports your life science or IVD manufacturing needs and helps your company achieve its strategic objectives.",
   "position": 5
  },
  {
   "title": "Argonaut Manufacturing Services - PharmaSource",
   "url": "https://pharmasource.global/directory/argonaut-manufacturing-services",
   "description": "Argonaut specialises in aseptic fill/finish, in-vitro diagnostic (IVD) manufacturing, and life science product development. Their services include reagent and diagnostic manufacturing, drug product aseptic fill and finish, lyophilized reagents, assay simplification, and complete supply chain management. Argonaut ensures high regulatory compliance and offers flexible, responsive solutions, with a robust quality management system. [...] ### Description\n\nArgonaut Manufacturing Services is a leading contract manufacturing organisation (CMO) providing comprehensive solutions for the biopharma and life sciences industries. [...] Argonaut’s experienced team supports the evolving needs of emerging and established markets, cementing their position as a trusted partner in the global CMO landscape.\n\n### Capabilities\n\n### Contact Information\n\n### Related Listings\n\nforma-logo-light\n\n## Forma Life Sciences\n\n691dfac4a72e6094a6162f67_Monobiologics logo transparent-2\n\n## MonoBiologics\n\nimages\n\n## Healthy life pharma\n\n### AI + Digital Maturity in Contract Manufacturing 2026",
   "position": 6
  }
 ],
 "lyophilized master mix patent US PCR bead": [
  {
   "title": "FS RT-qPCR Master Mix (Lyophilized Beads)",
   "url": "https://www.hzymesbiotech.com/pcr-master-mix/fs-rt-qpcr-master-mix-lyophilized-beads",
   "description": "FS RT-qPCR Master Mix (Lyophilized beads) is a RT-qPCR reagent specifically designed for RNA, suitable for single or multiplex quantitative PCR detection using",
   "position": 1
  },
  {
   "title": "MS qPCR Master Mix (Lyophilized Beads) from Hzymes ...",
   "url": "https://www.biocompare.com/25138-Assay-Kit/23471751-MS-qPCR-Master-Mix-Lyophilized-Beads",
   "description": "Lyophilized bead-format qPCR master mix for convenient storage and consistent performance. Time~50 min (qPCR) Range100 to 106 copies",
   "position": 2
  },
  {
   "title": "New England Biolabs® Launches LyoPrime Luna® RT-qPCR Master Mix, the First Lyophilized Product Since its Acquisition of Fluorogenics™",
   "url": "https://www.neb.com/en-us/about-neb/news-and-press-releases/new-england-biolabs-launches-lyoprime-luna-rt-qpcr-master-mix-the-first-lyophilized-product-since-its-acquisition-of-fluorogenics",
   "description": "IPSWICH, Mass., (February 09, 2022) — Today, New England Biolabs (NEB®) announced the release of its first lyophilized product manufactured by Fluorogenics: the LyoPrime Luna Probe One-Step RT-qPCR Mix with UDG. This lyophilized master mix exhibits the same versatile features and strong performance of the previously released liquid 4X mix and enables sensitive, linear real-time detection of target RNA sequences now in a room temperature-stable format. [...] Nicole Nichols, Associate Director, Applications and Product Development. [...] to RNA workflows, and dUTP to reduce carryover contamination risk between reactions.",
   "position": 3
  },
  {
   "title": "Lyophilized Ready-to-Use and Load PCR Master Mix",
   "url": "https://www.kerafast.com/productgroup/321/lyophilized-ready-to-use-and-load-pcr-master-mix",
   "description": "This high sensitivity, ready-to-use and load PCR mix is available in a lyophilized form for room temperature storage and transportation.",
   "position": 4
  },
  {
   "title": "PCR Beads Lyophilised Master Mix - Safety Data Sheet",
   "url": "https://patents.google.com/patent/WO2024018284A1/en",
   "description": "The product contains no substances which are considered to be hazardous to health at their given concentration.",
   "position": 5
  },
  {
   "title": "Lyophilized Ready-to-Use Mix for the Real-Time ...",
   "url": "https://www.researchgate.net/publication/351639275_Lyophilized_Ready-to-Use_Mix_for_the_Real-Time_Polymerase_Chain_Reaction_Diagnosis",
   "description": "Advances in lyophilization technology have enabled the development of PCR reagents in a stabilized, freeze-dried (lyophilized) format, such as cakes or beads (",
   "position": 6
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 "诺唯赞 冻干 荧光定量 PCR 试剂盒 Vazyme 冻干球": [
  {
   "title": "GO-Lyo U+ One Step RT-qPCR Probe Kit - 冻干试剂 - 诺唯赞",
   "url": "https://bio.vazyme.com/product/936.html",
   "description": "法荧光定量・ 荧光微球・ 价格 ¥ 3720. Kit是一款含有冻干赋形剂,适用于检测RNA模板的无甘油一步法RT-qPCR试剂,可搭配合适的冻干工艺进行冻干。",
   "position": 1
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   "title": "诺唯赞-生命科学-分子生物学_核酸提取_细胞生物学_蛋白生物学_高通量_分子诊断_生物耗材",
   "url": "https://bio.vazyme.com",
   "description": "DNA建库系列   RNA建库系列   多重扩增系列   表观遗传系列   单细胞系列   三代建库系列   杂交捕获系列   DNA&RNA共建库系列   磁珠系列   定量系列   接头系列   环化&转化试剂   自动化移液工作站   NGS自动化\n\n  PCR   逆转录   qPCR   一步法RT-qPCR   一步法RT-PCR   冻干试剂   等温扩增   PCR仪\n\n  自动化核酸提取仪   自动化移液工作站   动物疫病诊断   实时荧光定量PCR仪   化学发光设备\n\n  核酸提取系列   DNA建库系列   RNA建库系列   多重扩增系列   DNA&RNA共建库系列\n\n  分子实验耗材   设备配套耗材   细胞培养耗材\n\n  分子原料   免疫原料   细胞蛋白原料   生物微球   哺乳动物表达系统\n\n  标志物检测试剂盒   化学发光设备   化学发光设备耗材\n\n  高保真PCR   快速PCR   普通PCR   高产量PCR   长片段PCR   热启动PCR   直接扩增PCR   PCR相关 [...] - 逆转录\n  - qPCR\n  - 一步法RT-qPCR\n  - 一步法RT-PCR\n  - 冻干试剂\n  - 等温扩增\n  - PCR仪\n  - 自动化核酸提取仪\n  - 自动化移液工作站\n  - 动物疫病诊断\n  - 实时荧光定量PCR仪\n  - 化学发光设备\n  - 核酸提取系列\n  - DNA建库系列\n  - RNA建库系列\n  - 多重扩增系列\n  - DNA&RNA共建库系列\n  - 分子实验耗材\n  - 设备配套耗材\n  - 细胞培养耗材\n  - 分子原料\n  - 免疫原料\n  - 细胞蛋白原料\n  - 生物微球\n  - 哺乳动物表达系统\n  - 标志物检测试剂盒\n  - 化学发光设备\n  - 化学发光设备耗材 [...] 上新 | 新一代全能型片段化酶建库试剂盒：多维度耐受革新，数据更均一！\n\nREAD MORE\n\n中国流式抗体的可靠新选择：为您的实验保驾护航\n\nREAD MORE\n\n解决方案 | 从增殖到凋亡：如何打造肿瘤表型检测完美数据链？\n\n解决方案 | 从增殖到凋亡：如何打造肿瘤表型检测完美数据链？\n\nREAD MORE\n\n南京诺唯赞生物科技股份有限公司\n\n友情链接：诺唯赞海外  |  诺唯赞医疗  |  生物医药\n\n 联系我们\n\n电话\n\n电话：400-600-9335\n\n邮箱\n\n销售咨询 sales@vazyme.com\n\n邮箱\n\n技术支持 support@vazyme.com\n\n邮箱\n\n市场推广 marketing@vazyme.com\n\n3D虚拟展馆\n\n抖音官媒\n\n微博\n\n哔哩哔哩\n\n产品中心\n\n资源支持\n\n解决方案\n\n新闻资讯\n\n技术平台\n\n关于我们\n\nCopyright © 南京诺唯赞生物科技股份有限公司\n\n网站建设：中企动力  南京",
   "position": 2
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  {
   "title": "产品中心-细胞生物学_南京诺唯赞生物科技股份有限公司",
   "url": "https://bio.vazyme.com/products_2.html",
   "description": "- 逆转录\n  - qPCR\n  - 一步法RT-qPCR\n  - 一步法RT-PCR\n  - 冻干试剂\n  - 等温扩增\n  - PCR仪\n  - 自动化核酸提取仪\n  - 自动化移液工作站\n  - 动物疫病诊断\n  - 实时荧光定量PCR仪\n  - 化学发光设备\n  - 核酸提取系列\n  - DNA建库系列\n  - RNA建库系列\n  - 多重扩增系列\n  - DNA&RNA共建库系列\n  - 分子实验耗材\n  - 设备配套耗材\n  - 细胞培养耗材\n  - 分子原料\n  - 免疫原料\n  - 细胞蛋白原料\n  - 生物微球\n  - 哺乳动物表达系统\n  - 标志物检测试剂盒\n  - 化学发光设备\n  - 化学发光设备耗材 [...] DNA建库系列   RNA建库系列   多重扩增系列   表观遗传系列   单细胞系列   三代建库系列   杂交捕获系列   DNA&RNA共建库系列   磁珠系列   定量系列   接头系列   环化&转化试剂   自动化移液工作站   NGS自动化\n\n  PCR   逆转录   qPCR   一步法RT-qPCR   一步法RT-PCR   冻干试剂   等温扩增   PCR仪\n\n  自动化核酸提取仪   自动化移液工作站   动物疫病诊断   实时荧光定量PCR仪   化学发光设备\n\n  核酸提取系列   DNA建库系列   RNA建库系列   多重扩增系列   DNA&RNA共建库系列\n\n  分子实验耗材   设备配套耗材   细胞培养耗材\n\n  分子原料   免疫原料   细胞蛋白原料   生物微球   哺乳动物表达系统\n\n  标志物检测试剂盒   化学发光设备   化学发光设备耗材\n\n  高保真PCR   快速PCR   普通PCR   高产量PCR   长片段PCR   热启动PCR   直接扩增PCR   PCR相关 [...] Gelred无毒核酸染料   DNA Marker   电泳缓冲液\n\n  快速克隆   快速定点突变   T4 DNA连接酶   限制性内切酶   TA克隆/平末端克隆载体   化学感受态细胞\n\n  逆转录预混液（qPCR专用）   通用型逆转录试剂（PCR/qPCR）   逆转录单酶   miRNA逆转录专用试剂盒   5’RACE & 3’RACE扩增   病原多重检测专用逆转录   单细胞预扩增\n\n  染料法荧光定量专用预混液   探针法荧光定量专用预混液   miRNA荧光定量专用试剂   宿主细胞残留核酸检测   实时荧光定量PCR仪   KASP基因分型\n\n  柱式法提取   磁珠法手动提取   磁珠法自动化提取\n\n  沉淀法提取   柱式法提取   磁珠法自动化提取\n\n  柱式法提取   磁珠法手动提取   磁珠法自动化提取\n\n  酶类   清除剂   样本保存液   样本裂解液\n\n  T细胞分选   B细胞分选\n\n  胎牛血清   平衡缓冲液   新生牛血清\n\n  支原体检测   支原体清除\n\n  PEI转染试剂   脂质体转染试剂   LNP转染试剂",
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  {
   "title": "qPCR-产品中心-南京诺唯赞生物科技股份有限公司",
   "url": "https://bio.vazyme.com/products_27/45.html",
   "description": "南京诺唯赞生物科技股份有限公司・ 实时荧光定量PCR仪化学发光设备miRNA荧光定量专用试剂・ 冻干试剂等温扩增PCR仪",
   "position": 4
  },
  {
   "title": "分子生物学-qPCR系列_南京诺唯赞生物科技股份有限公司",
   "url": "https://bio.vazyme.com/products_64.html",
   "description": "- 逆转录\n  - qPCR\n  - 一步法RT-qPCR\n  - 一步法RT-PCR\n  - 冻干试剂\n  - 等温扩增\n  - PCR仪\n  - 自动化核酸提取仪\n  - 自动化移液工作站\n  - 动物疫病诊断\n  - 实时荧光定量PCR仪\n  - 化学发光设备\n  - 核酸提取系列\n  - DNA建库系列\n  - RNA建库系列\n  - 多重扩增系列\n  - DNA&RNA共建库系列\n  - 分子实验耗材\n  - 设备配套耗材\n  - 细胞培养耗材\n  - 分子原料\n  - 免疫原料\n  - 细胞蛋白原料\n  - 生物微球\n  - 哺乳动物表达系统\n  - 标志物检测试剂盒\n  - 化学发光设备\n  - 化学发光设备耗材 [...] DNA建库系列   RNA建库系列   多重扩增系列   表观遗传系列   单细胞系列   三代建库系列   杂交捕获系列   DNA&RNA共建库系列   磁珠系列   定量系列   接头系列   环化&转化试剂   自动化移液工作站   NGS自动化\n\n  PCR   逆转录   qPCR   一步法RT-qPCR   一步法RT-PCR   冻干试剂   等温扩增   PCR仪\n\n  自动化核酸提取仪   自动化移液工作站   动物疫病诊断   实时荧光定量PCR仪   化学发光设备\n\n  核酸提取系列   DNA建库系列   RNA建库系列   多重扩增系列   DNA&RNA共建库系列\n\n  分子实验耗材   设备配套耗材   细胞培养耗材\n\n  分子原料   免疫原料   细胞蛋白原料   生物微球   哺乳动物表达系统\n\n  标志物检测试剂盒   化学发光设备   化学发光设备耗材\n\n  高保真PCR   快速PCR   普通PCR   高产量PCR   长片段PCR   热启动PCR   直接扩增PCR   PCR相关 [...] 南京诺唯赞生物科技股份有限公司\n\n友情链接：诺唯赞海外  |  诺唯赞医疗  |  生物医药\n\n 联系我们\n\n电话\n\n电话：400-600-9335\n\n邮箱\n\n销售咨询 sales@vazyme.com\n\n邮箱\n\n技术支持 support@vazyme.com\n\n邮箱\n\n市场推广 marketing@vazyme.com\n\n3D虚拟展馆\n\n抖音官媒\n\n微博\n\n哔哩哔哩\n\n产品中心\n\n资源支持\n\n解决方案\n\n新闻资讯\n\n技术平台\n\n关于我们\n\nCopyright © 南京诺唯赞生物科技股份有限公司\n\n网站建设：中企动力  南京",
   "position": 5
  },
  {
   "title": "设备配套耗材_南京诺唯赞生物科技股份有限公司",
   "url": "https://bio.vazyme.com/products_21.html",
   "description": "诺唯赞是一家围绕酶、抗原、抗体等功能性蛋白及高分子有机材料进行技术研发・ 实时荧光定量PCR仪 ・ 实时荧光定量PCR仪",
   "position": 6
  }
 ],
 "air-dryable oven drying PCR master mix humidity indicator desiccant packaging": [
  {
   "title": "Air-Dryable™ qPCR and RT-qPCR Mixes Master Mixes",
   "url": "https://www.meridianbioscience.com/lifescience/products/molecular/air-dryable-qpcr-mix-4x",
   "description": "Meridian's unique air-dryable qPCR mixes are designed for developing ambient temperature stable, multiplex molecular diagnostic tests.",
   "position": 1
  },
  {
   "title": "Lyophilisable and Air-Dryable Mixes",
   "url": "https://pcrbio.com/usa/products/lyophilisable-and-air-dryable",
   "description": "Lyo-ready and Air-dryable qPCR and RT-qPCR reagents. Cutting edge qPCR performance with the option to dry down reaction mixes by lyophilisation or air-drying.",
   "position": 2
  },
  {
   "title": "Lab Desiccants and Drying Agents | Fisher Scientific",
   "url": "https://www.fishersci.com/us/en/browse/90218014/lab-desiccants-and-drying-agents",
   "description": "Some desiccants contain an indicator or additive that produces a color change with moisture absorption. The indicator allows the user to see when the desiccant has absorbed its maximum amount of moisture and needs to be replaced or regenerated.\n\nSome desiccants can be reused many times simply by heating them in an oven to allow moisture to evaporate. For indicating desiccants, one can also easily tell when the desiccant is again ready to use by the change back to the original color. [...] In the lab, desiccants are commonly used in desiccators and desiccator cabinets, with in-line air and gas drying columns, in absorption bulbs, U-tubes, glove boxes, sealed chambers, and wherever a dry environment is required. They are also used during transport, for storage, and maintaining materials and products ─ everything from clothing to electronics.\n\nThe moisture may come from a variety of sources: [...] Humidity Sponge™ Dessicant Window Type, Fisherbrand™\n\n### Humidity Sponge™ Dessicant Window Type, Fisherbrand™\n\nMeet all drying requirements with these humidity sponges. Fisherbrand™ Dessicant Window Type Humidity Sponges™ are non-toxic and Class M3.5 cleanroom-compatible.\n\n|  |  |\n --- |\n| CAS | 1302-78-9 |\n\n### About Us\n\n### Programs and Services\n\n### Customer Support\n\n### Connect with Us\n\nFisher Scientific - part of Thermo Fisher Scientific",
   "position": 3
  },
  {
   "title": "Desiccants USA",
   "url": "https://www.impakcorporation.com/desiccants",
   "description": "fan of 30% - 80% humidity indicating cards  \n Humidity Indicator Cards\n\nMolecular Sieve desiccant  \n Molecular Sieve Desiccant\n\nDesiccant Paper in waterproof camera for condensation  \n Desiccant Paper\n\nsilver mylarfoil pouch standing in a void  \n Desiccant Bags\n\nstring of largr container desiccant pouches with blue plastic hang hook  \n Cargo Container Desiccants\n\nindicating dricap style desiccant clear capsules  \n Desiccant Capsules [...] Refine Search\n\n Custom Desiccants / Sorbents\n All About Desiccants\n Anti-Fog Camera Silica Gel Paper\n MoisturePak™ 62% Humidity Control\n Bulk Desiccants\n Caps and Vials\n Cargo Container Desiccant\n Compression Molded\n Desiccant Bags\n Desiccant Capsules\n Desiccant Packets\n Desiccant Paper\n DriBox™ - Reusable Moisture Control\n High Temperature Desiccant\n Humidity Indicator Cards\n Liquid Absorbers\n\nthree .5g indicating silica gel desiccant packets\n\nQuick View [...] - do not attempt to dry/bake desiccant pouches! We also carry a 5lb (80 unit) clay desiccant bag that can be placed in an oven.",
   "position": 4
  },
  {
   "title": "A Step-By-Step Tutorial On How To Dry A Desiccant Bag",
   "url": "https://www.roycopackaging.com/blogs/news/a-step-by-step-tutorial-on-how-to-dry-a-desiccant-bag",
   "description": "These handy packets keep your goodies dry by sucking up water from the air. you need an oven. Next up is an oven thermometer. Don't let",
   "position": 5
  },
  {
   "title": "Drying rechargeable desiccant beads - User Mods - Bambu Lab Community Forum",
   "url": "https://forum.bambulab.com/t/drying-rechargeable-desiccant-beads/120521",
   "description": "There are not “cobalt fumes”.  \nCobalt can be absorbed through skin or inhaled in the industry (metal working, mining, …) where there are tiny cobalt particles suspended in the air.  \nSilicagel that uses cobalt as humidity indicator should not be in contact with any food preparing hardware or similar.\n\nOnly toxic as fumes, leaves no residue!!\n\nPowered by Discourse, best viewed with JavaScript enabled [...] For starters use two large enough and HEAT resistant jars, glasses, what is required for your amounts.  \nPre-heat them by rinsing with boiling water or placing in the oven at about 60-80 degrees Celsius - this will prevent moisture from condensating later which makes the beads stick to the walls… [...] Is that food safe? I’m purposefully avoiding taking any filament into the kitchen to avoid microplastics and fumes. (If the silica gel doesn’t off-gas and only releases steam, I could see that being food safe.)\n\nThe instruction should be on the bag. Here’s what’s on mine, but read yours because the desiccants can be different.\n\nDryNDry_1\n\nDryNDry\\_1768×1024 230 KB\n\n  \n\nDryNDry_2\n\nDryNDry\\_21024×768 245 KB\n\nDryNDry_1\nDryNDry_2",
   "position": 6
  }
 ]
}