Discussion on the validity period determination method of commercial ready-to-use TSA medium
10.19778/j.chp.2024.03.012
- VernacularTitle:商品化的预制TSA培养基有效期确定方法的探讨
- Author:
Wenyue KOU
1
;
Yuru JIANG
;
Luyao HAO
;
Yuyi TANG
;
Xueyun ZHOU
;
Xiujuan ZHU
;
Zhen QIAN
;
Ge JIN
;
Jiaojiao WANG
Author Information
1. 北京生物制品研究所有限责任公司,北京 100176
- Keywords:
commercial;
TSA medium;
appearance;
pH;
medium suitability;
sterility
- From:
Drug Standards of China
2024;25(3):289-295
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the quality and stability of commercial ready-to-use tryptone soya agar(TSA)after storing at 2-25 ℃ for different storage duration under dark condition in order to discuss a determination method of validity period for medium.Methods:Three consecutive batches of ready-to-use TSA medium from two manufac-turers were selected and stored at 2-25 ℃ under dark conditions for 30,90 and 180 days,respectively.The appearance,pH,medium suitability and sterility of the medium were tested.Results:The results of appearance,pH,suitability and sterility of TSA medium from two manufacturers for each batch under different storage duration all met the requirements of the Chinese Pharmacopoeia 2020 Volume IV on the quality control of medium.Conclusion:The TSA medium from two manufacturers all met the requirements when stored for 180 days at 2-25 ℃ under dark condition,indicating that the validity period of TSA medium from two manufacturers can reach 180 days.