冻干后，成品色差不均

神龙奇云

药液为浅黄色，冻干后，成品色差不均匀，有的白色，有点浅黄，这是什么原因？

飞凌大圣

1、有浅黄的部分是整瓶药，还是表面，或者底部？有规律出现还是随机的？
2、该产品对温度是否敏感？升温时的最高温度是多少？
3、冻干机升温的时候，是否有受热不均匀的情况？

希望楼主提供详细一点的信息，谢谢！

beiwei5du

是工艺开发阶段，还是商业化生产中偶然的一批？？？
可不可能还有结晶程度或者晶型的原因？？？

Cake Color

Lyophilized drug product should ideally exhibit a uniform cake color36 (generally white to off-white). However, in some cases colored cakes may be observed, for example, in case of a colored active pharmaceutical ingredient (Fig. 22). The authors are not aware of any systematic study assessing the impact of a non-uniform color on product quality. Effects such as cryo-concentration and crystallization may lead to a slightly different color in different sections of the dried cake, potentially due to non-uniform distribution of the drug substance, the extent of crystallization, or the crystallization of different polymorphs.37 In the opinion of the authors, sufficient product quality data should be generated to support the acceptability of a non-uniform color in order to classify it as cosmetic only. A change in color after lyophilization or during storage needs to be considered with care, because it may be attributed to a Maillard reaction (e.g., sucrose, maltose, lactose),11,38 oxidation of protein (e.g., related to tryptophan),39,40 or oxidation of excipients (e.g., histidine),41 which may impact CQAs and, hence, may warrant rejection of such product.

选自：Lyophilized Drug Product Cake Appearance: What Is Acceptable?

神龙奇云

谢谢！老师

yc20160802

供参考
https://www.ouryao.com/thread-441217-1-1.html

神龙奇云

yc20160802 发表于 2018-4-23 10:09
供参考
https://www.ouryao.com/thread-441217-1-1.html

谢谢！老师

2944891842

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小金库

谢谢大家分享。