本帖最后由 beiwei5du 于 2018-1-13 20:04 编辑
了解一下这个，是使用基于1/1000日剂量的转换公式，使用ADI（毕竟溶剂不可能有TDD），但是我觉得使用这个方式主要针对于不易挥发的溶剂吧，毕竟对于易挥发的溶剂，是否可以参照https://www.ouryao.com/forum.php?mod=viewthread&tid=318326&highlight=viracept，主要层面是在于保证能彻底做到挥发干净吧。 Dear Mr. Karan Shah, For your information even 99% IPA will leave some residue behind on equipment surfaces. I have to agree with kingjw1, isopropyl alcohol is a Class 3 solvent. As per ICH Q3C Guideline – “Impurities: Guideline for Residual Solvents,” Class 3 solvents are considered as solvents with low toxic potential and such solvents have Permitted daily exposure (PDE) of 50 mg or more per day. Before going into detail of how to test and sample IPA residues, first you need to develop an acceptance criterion (i.e. how much amount of IPA is considered acceptable to be carried over to next product). For which you may use the following formula: CV acceptance criterion = (ADI x Batch size of next product x Swab area) / (Maximum daily dose of next product x Product contact surface area) The above formula is the modification of formula used for Dose criterion, where (0.001*Minimum daily dose) is replaced by ADI (acceptable daily intake) value. The formula mentioned above is only for swab samples, you can modify it to derive limits for rinse samples. The ADI value for Isopropanol is 2.4 mg/kg bw/day (reference:
http://www.efsa.europa.eu/en/scdocs/doc/202.pdf16
) i.e. 2.4 x 70 = 168 mg/person (70 kg is the body weight for a normal person you may change it as per your country’s regulations). Determine the acceptance criterion by using ADI = 168 mg/person in the formula mentioned earlier. You may collect swab or rinse sample from the equipment surfaces and analyze the collected samples using Gas Chromatography to determine the content of IPA. Compare the results with the acceptance criteria to derive a conclusion. Thanks. Ovais
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发表于 2016-9-17 15:50:56
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