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純水檢驗問題

#1
UCCU 發表於 2020 / 07 / 30
想詢問就USP(1231),執行純水檢驗用之培養基Plate Count Agar,效能試驗(8.5.3)有提到可用綠膿桿菌(ATCC902)、枯草桿菌(ATCC6633),倘用m-HPC agar 或 R2A agar,是否也要用綠膿桿菌(ATCC902)、枯草桿菌(ATCC6633)檢驗? 那檢驗條件溫度時間應為何?
管理員回覆


您好,
USP沒有建議R2A 培養基試驗菌種,參考歐洲藥典European Pharmacopeia的生長促進試驗。檢驗條件溫度時間:35°C; 24 hrs. ; aerobic and 20-25 °C; 72 hrs.; aerobic.
Inoculum 35°C / 24h (Escherichia coli ATCC 8739 (WDCM 00012)) 10 - 100
Inoculum 35°C / 24h (Pseudomonas aeruginosa ATCC 9027 (WDCM 00026)) 10 - 100
Inoculum 35°C / 24h (Staphylococcus aureus ATCC 6538 (WDCM 00032)) 10 - 100
Inoculum 35°C / 24h (Bacillus subtilis ATCC 6633 (WDCM 00003)) 10 - 100
Colony count 35°C/24 h (Escherichia coli ATCC 8739 (WDCM 00012))  
Colony count 35°C/24 h (Pseudomonas aeruginosa ATCC 9027 (WDCM 00026))  
Colony count 35°C/24 h (Staphylococcus aureus ATCC 6538 (WDCM 00032))  
Colony count 35°C/24 h (Bacillus subtilis ATCC 6633 (WDCM 00003))  
Recovery rate 35 °C/24 h (Escherichia coli ATCC 8739 (WDCM 00012)) ≥ 70 %
Recovery rate 35 °C/24 h (Pseudomonas aeruginosa ATCC 9027 (WDCM 00026)) ≥ 70 %
Recovery rate 35 °C/24 h (Staphylococcus aureus ATCC 6538 (WDCM 00032)) ≥ 70 %
Recovery rate 35 °C/24 h (Bacillus subtilis ATCC 6633 (WDCM 00003)) ≥ 70 %
Inoculum 20-25°C / 72h (Escherichia coli ATCC 8739 (WDCM 00012)) 10 - 100
Inoculum 20-25°C / 72h (Pseudomonas aeruginosa ATCC 9027 (WDCM 00026)) 10 - 100
Inoculum 20-25°C / 72h (Staphylococcus aureus ATCC 6538 (WDCM 00032)) 10 - 100
Inoculum 20-25°C / 72h (Bacillus subtilis ATCC 6633 (WDCM 00003)) 10 - 100
Colony count 20-25°C/72 h (Escherichia coli ATCC 8739 (WDCM 00012))  
Colony count 20-25°C/72 h (Pseudomonas aeruginosa ATCC 9027 (WDCM 00026))  
Colony count 20-25°C/72 h (Staphylococcus aureus ATCC 6538 (WDCM 00032))  
Colony count 20-25°C/72 h (Bacillus subtilis ATCC 6633 (WDCM 00003))  
Recovery rate 20-25 °C/72 h (Escherichia coli ATCC 8739 (WDCM 00012)) ≥ 70 %
Recovery rate 20-25 °C/72 h (Pseudomonas aeruginosa ATCC 9027 (WDCM 00026)) ≥ 70 %
Recovery rate 20-25 °C/72 h (Staphylococcus aureus ATCC 6538 (WDCM 00032)) ≥ 70 %
Recovery rate 20-25 °C/72 h (Bacillus subtilis ATCC 6633 (WDCM 00003)) ≥ 70 %
檢驗條件溫度時間35°C; 24 hrs.;aerobic and 20-25 °C; 72 hrs.; aerobic.

 
From TPDA
2020/8/12

 

 

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