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欧洲药典EUP2005CH 2.6.13 细菌含量测试
2.6.13. Test for specified micro-organisms EUROPEAN PHARMACOPOEIA 5.0Table 2.6.12.-1. – Most-probable-number values of bacteriaThree tubes at each level of dilutionNumber of positive tubes Category*0.1 g 0.01 g 0.001 gMPNpergram 1 295 per centconfidencelimits0 0 0 < 3 – –0 1 0 3 x < 1 171 0 0 3 x 1 211 0 1 7 x 2 271 1 0 7 x 2 281 2 0 11 x 4 352 0 0 9 x 2 382 0 1 14 x 5 482 1 0 15 x 5 502 1 1 20 x 8 612 2 0 21 x 8 633 0 0 23 x 7 1293 0 1 38 x 10 1803 1 0 43 x 20 2103 1 1 75 x 20 2803 2 0 93 x 30 3903 2 1 150 x 50 5103 2 2 210 x 80 6403 3 0 240 x 100 14003 3 1 460 x 200 24003 3 2 1100 x 300 48003 3 3 > 1100 – –Category 1: Normal results, obtained in 95 per cent of the cases.Category 2: Less likely results, obtained in only 4 per cent of cases. Theseare not to be used for important decisions. Results that are even less likelythan those of category 2 are not mentioned and are always unacceptable.EFFECTIVENESS OF CULTURE MEDIA AND VALIDITYOF THE COUNTING METHODGrow the bacterial test strains separately in containerscontaining a suitable liquid medium (such as brothmedium A) at 30 °C to 35 °C for 18 h to 24 h. Grow thefungal test strains separately on a suitable agar medium(such as medium C without antibiotics) at 20 °C to 25 °C for48 h for Candida albicans and at 20 °C to 25 °C for 7 daysfor Aspergillus niger.Staphylococcus aureus such as ATCC 6538 (NCIMB 9518,CIP 4.83)Escherichia coli such as ATCC 8739 (NCIMB 8545,CIP 53.126)Bacillus subtilis such as ATCC 6633 (NCIMB 8054,CIP 52.62)Candida albicans such as ATCC 10231 (NCPF 3179,IP 48.72)Aspergillus niger such as ATCC 16404 (IMI 149007,IP 1431.83)Use buffered sodium chloride-peptone solution pH 7.0to make reference suspensions containing about100 colony-forming units per millilitre. Use the suspensionof each of the micro-organisms separately as a controlof the counting methods, in the presence and absence ofthe product to be examined. When testing the membranefiltration method or the plate-count method, a count of anyof the test organisms differing by not more than a factor offive from the calculated value from the inoculum is to beobtained. When testing the most-probable-number methodthe calculated value from the inoculum is to be within the95 per cent confidence limits of the results obtained. Totest the sterility of the medium and of the diluent and theaseptic performance of the test, carry out the method usingsterile sodium chloride-peptone solution pH 7.0 as the testpreparation. There must be no growth of micro-organisms.INTERPRETATION OF THE RESULTSThe bacterial count will be considered to be equal to theaverage number of colony-forming units found on agarmedium B. The fungal count will be considered to be equalto the average number of colony-forming units on agarmedium C. The total viable aerobic count is the sum of thebacterial count and the fungal count as described above. Ifthere is evidence that the same types of micro-organismsgrow on both media this may be corrected. If the countis carried out by the most-probable-number method thecalculated value is the bacterial count. |
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