Hebei Provincial Standard of the People's Republic of China
Latest
DB13/T 292-1996
Scope
In the formulation of this standard, the sampling method for penicillin residues in the environment and equipment after site clearance is equivalent to the "Guidelines for Preventing Cross-Contamination" compiled by the GMP Committee of the Japan Industrial Association, and other parts are not equivalent to the "Food and Drug Administration" of the United States Food and Drug Administration. and Penicillin Contamination in Drugs" and the relevant content of the United States Federal Regulations. This standard is proposed by the Hebei Provincial Pharmaceutical Administration. This standard was drafted by: North China Pharmaceutical Co., Ltd. The main drafters of this standard: Yan Xiya, Su Qin, Li Lingmei, Liu Chunyan, Sun Wei. This standard specifies the test method for the determination of trace amounts of penicillin by microbiological methods. This standard is applicable to the determination of trace amounts of penicillin in finished products, the environment after site clearance, equipment and air. The minimum detection volume is 0.0008u/ml.