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CERTIFICATE OF ANALYSIS
Product |
Prednisolone Base |
Report Date |
Feb.25,2014 |
Batch No |
20200202 |
Quantity |
100KGS |
Manufacturing Date |
Feb.18,2020 |
Expiry Date |
Feb, 2025 |
Item |
BP2010 Specification |
Testing Result |
Appearance |
White or almost white crystalline powder |
White powder |
Specific Optical Rotation |
+96°-+102° |
+100.5° |
Identification |
A: IR;B: TLC |
Positive |
Related Substances |
Any impurity≤1.0% 0.50%≤Only one impurity≤1.0% Total impurity ≤2.0% |
0.58% Meets The Requirements 0.84% |
Loss on drying |
≤ 1.00% |
0.44% |
Assay |
97.0%-103.0% |
99.48 % |
Conclusion |
The above product conforms to the specification of BP2010 |