原料药的外观可以不列入注册质量标准中吗?
注册申报
2023-10-09 09:40 就抠呗     
YD111 2024-01-10 14:00

不可以,中国药典2020年版二部凡例明确指出了,楼上各位老师也解答得很详细。另外有个问题:是什么样的情况才会提出原料药的外观不列入质量标准这个问题呢,盼题主分享~

4个回答

不可以

具体见《中国药典》凡例,《中国药典》2020年版二部凡例

九、品种正文内容根据品种和剂型的不同,按顺序可分别列有:(1)品名(包括中文名、汉语拼音与英文名);(2)有机药物的结构式;(3)分子式与分子量;
(4)来源或有机药物的化学名称;(5)含量或效价规定;(6)处方;(7)制法;(8)性状;(9)鉴别;(10)检查;(11)含量或效价测定;(12)类别;(13)规格;
(14)贮藏;(15)制剂;(16)标注;(17)杂质信息等。
原料药与制剂中已知杂质的名称与结构式等信息一般均在原料药正文中列出,相应制剂正文直接引用。复方制剂中活性成分相互作用产生的杂质,一般列在该品种正文项下。
十五、性状项下记载药品的外观、臭、味、溶解度以及物理常数等。
  (1)外观性状是对药品的色泽和外表感观的规定,其中臭与味指药品本身所固有的,可供制剂开发时参考。
  (2)溶解度是药品的一种物理性质。各品种项下选用的部分溶剂及其在该溶剂中的溶解性能,可供精制或制备溶液时参考;对在特定溶剂中的溶解性能需作质量控制时,在该品种检查项下另作具体规定。药品的近似溶解度以下列名词术语表示:
  极易溶解       系指溶质1g(ml)能在溶剂不到1ml中溶解;
  易溶              系指溶质1g(ml)能在溶剂1~不到10ml中溶解;
  溶解              系指溶质1g(ml)能在溶剂10~不到30ml中溶解;
  略溶              系指溶质1g(ml)能在溶剂30~不到100ml中溶解;
  微溶	          系指溶质1g(ml)能在溶剂100~不到1000ml中溶解;
  极微溶解       系指溶质1g(ml)能在溶剂1000~不到10000ml中溶解;
  几乎不溶或不溶   系指溶质1g(ml)在溶剂10000ml中不能完全溶解。
  试验法:除另有规定外,称取研成细粉的供试品或量取液体供试品,于25℃士2℃一定容量的溶剂中,每隔5分钟强力振摇30秒钟;观察30分钟内的溶解情况,如无目视可见
的溶质颗粒或液滴时,即视为完全溶解。
  (3)物理常数包括相对密度、馏程、熔点、凝点、比旋度、折光率、黏度、吸收系数、碘值、皂化值和酸值等;其测定结果不仅对药品具有鉴别意义,也可反映药品的纯度,
是评价药品质量的主要指标之一。
2023-10-10 16:30 红秀     

应当是需要列入的,在中国药典二部通则中【十五、性状项下记载药品的外观、臭、味、溶解度以及物理常数等。 (1)外观性状是对药品的色泽和外表感观的规定,其中臭与味指药品本身所固有的,可供制剂开发时参考。】,原料是需要有性状项的,外观又属于性状项下。

并且外观的变化一定程度上预示着产品存在某种的改变(物理或者化学性质),是最直观的检项,检验也不复杂,建议不要省去。

——如有错误,请指正。

2023-10-09 11:04 贰雯丶     
识林-白桦 2023-10-16 10:34

可在识林网站查看,详见中国药典二部通则

不能。

参照20版药典二部凡例:三、药品标准由品种正文及其引用的凡例、通用技术要求共同构成。本版药典收载的凡例、通则/生物制品通则、总论的要求对未载入本版药典的其他药品标准具同等效力。 十五、性状项下记载药品的外观、臭、味、溶解度以及物理常数等。(1)外观性状是对药品的色泽和外表感观的规定,其中臭与味指药品本身所固有的,可供制剂开发时参考。

2023-10-09 13:50 用户b0qx     

关于质量标注的建立,可以参考ICHQ6A,性状是通用性测试,适用于所有的原料药,需要列入标准。


ICH Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products:

3.2 Universal Tests / Criteria

Implementation of the recommendations in the following section should take into account the ICH Guidelines “Text on Validation of Analytical Procedures” and “Validation of Analytical Procedures: Methodology”.
3.2.1 New Drug Substances
The following tests and acceptance criteria are considered generally applicable to all new drug substances.
a) Description: a qualitative statement about the state (e.g. solid, liquid) and color of the new drug substance. If any of these characteristics change during storage, this change should be investigated and appropriate action taken.
b) Identification: identification testing should optimally be able to discriminate between compounds of closely related structure which are likely to be present. Identification tests should be specific for the new drug substance, e.g., infrared spectroscopy. Identification solely by a single chromatographic retention time, for example, is not regarded as being specific. However, the use of two chromatographic procedures, where the separation is based on different principles or a combination of tests into a single procedure, such as HPLC/UV diode array, HPLC/MS, or GC/MS is generally acceptable. If the new drug substance is a salt, identification testing should be specific for the individual ions. An identification test that is specific for the salt itself should suffice.
New drug substances which are optically active may also need specific identification testing or performance of a chiral assay. Please refer to 3.3.1.d) in this Guideline for further discussion of this topic.
c) Assay: A specific, stability-indicating procedure should be included to determine the content of the new drug substance. In many cases it is possible to employ the same procedure (e.g., HPLC) for both assay of the new drug substance and quantitation of impurities.
In cases where use of a non-specific assay is justified, other supporting analytical procedures should be used to achieve overall specificity. For example, where titration is adopted to assay the drug substance, the combination of the assay and a suitable test for impurities should be used.
d) Impurities: Organic and inorganic impurities and residual solvents are included in this category. Refer to the ICH Guidelines Impurities in New Drug Substances and Residual Solvents in Pharmaceuticals for detailed information.
Decision tree #1 addresses the extrapolation of meaningful limits on impurities from the body of data generated during development. At the time of filing it is unlikely that sufficient data will be available to assess process consistency. Therefore it is considered inappropriate to establish acceptance criteria which tightly encompass the batch data at the time of filing. (see section 2.5)

2023-10-09 14:20 匿名