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听众
性别保密
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发表于 2018-4-17 09:55:14
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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.
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