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CERTIFICATE OF ANALYSIS
Product: |
Prednisolone Base |
Report Date |
Mar.01,2020 |
Batch No.: |
20200301 |
Quantity |
200KGS |
Manufacturing Date |
Mar.01,2020 |
Expiry Date |
Mar. 2023 |
Item |
BP2010 Specification |
Testing Result |
Appearance |
White or almost white crystalline powder |
White powder
|
Specific Optical Rotation |
+96°-+102° |
+97.8° |
Identification |
A: IR;B: TLC |
Positive |
Related Substances |
Any impurity≤1.0% |
0.47% |
0.50%≤Only one impurity≤1.0% |
Meets The Requirements
|
|
Total impurity ≤2.0% |
0.80 % |
|
Loss on drying |
≤ 1.00% |
0.12% |
Assay |
97.0%-103.0% |
99.20 % |
Conclusion: The above product conforms to the specification of BP2010