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培養基效能試驗

#1
Joe 發表於 2021 / 03 / 15
請問USP<62>的選擇性培養基,其培養基效能試驗,是否與前一批次相比也有factor 2的標準
管理員回覆

您好,

根據USP <62> TEST FOR GROWTH-PROMOTING PROPERTIES, SOLID MEDIA
Perform Surface-Spread Method (see Plate-Count Methods under Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 〈61〉), inoculating each plate with a small number (not more than 100 cfu) of the appropriate microorganism. Incubate at the specified temperature for not more than the shortest period of time specified in the test. Growth of the microorganism comparable to that previously obtained with a previously tested and approved batch of medium occurs.
USP<61>Growth Promotion of Media
For solid media, growth obtained must not differ by a factor greater than 2 from the calculated value for a standardized inoculum. For a freshly prepared inoculum, growth of the microorganisms comparable to that previously obtained with a previously tested and approved batch of medium occurs. Liquid media are suitable if clearly visible growth of the microorganisms comparable to that previously obtained with a previously tested and approved batch of medium occurs.。
所以factor of 2 (50-200%)是針對購買的標準菌株。但如果在實驗室自己新鮮配置的菌株,則與前一合格批的檢測結果比對,如果是相當的(comparable),則通過試驗。所以USP<62>的選擇性培養基,其培養基效能試驗,與前一批次沒有factor 2的要求。


From TPDA
2021/5/18
 
 

 

 

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