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对胶体磷[~(32)P]酸铬注射液的无菌检查和核纯度检查方法进行研究,以对其无菌检查方法进行验证并建立核纯度检查方法。结果表明,可采用直接接种法,接种0.2 mL供试品至7.5 mL培养基管进行该产品的无菌检查;在核纯度检查方面,对放射性吸收套进行设计加工,改变了主核素和杂质核素测量比,用高纯锗γ谱仪测量出γ杂质的活度,用活度计测量出~(32)P活度,根据~(32)P和杂质核素的活度计算~(32)P核纯度。检查方法经验证准确可靠、简单易行,为产品的质量控制提供保证。
The colloidal phosphorus [~ (32) P] acid chromate injection of sterility and nuclear purity test methods to study its sterility test methods to verify and establish nuclear purity test method. The results showed that the direct inoculation method can be used to inoculate 0.2 mL of test sample to 7.5 mL medium tube for sterility test of the product; in the aspect of nuclear purity inspection, the radiation absorbing sleeve is designed and processed to change the main nuclide and impurities (32) P activity was measured by the activity meter and the activity of ~ (32) P and impurity nuclide was calculated as 32) P nuclear purity. The inspection method is verified to be accurate and reliable, simple and easy to provide assurance for the quality control of the product.