Customization: | Available |
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Varieties: | Infectious Disease Prevention Medicine |
Component: | Microorganism |
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TEST ITEMS |
SPECIFICATIONS |
TEST RESULTS |
Characters |
White to slight yellow powder, odorless and hygroscopic. In solution it is dextrorotatory. Free of foreign particles. |
Meet test |
Identification |
A;B;C The Positive reaction |
Complies |
Solubility |
Freely soluble in water,very slightly in alcohol,insoluble and inether |
Meet test |
Ph |
5.0 - 7.5 |
6.6 |
Loss on drying |
≤ 8.0% |
4.7% |
Assay |
Anhydrous potency≥600ug/mg |
678ug/mg |
Microbiological testing |
a)Microbial count: ≤ 10FCU/g at 25 ° C |
< 10CFU/g |
b) Microbial count: ≤ 10CFU/g at 35 ° C |
< 10CFU/g |
|
b)No.of fungi and mould: ≤ 50CFU/g |
Absence |
|
c)Pathogenic bacteria Staphylococcus Aureus:Absence/g Pseudomonas Aeruginosa:Absence/g E.Coli:Absence/g |
Absence |
|
Absence |
||
Absence |
||
CONCLUSION: COMPLY WITH USP.35 |