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东康源高纯泼尼松原粉53-03-2质量标准受多所学校科研机构认可
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PRODUCT |
PREDNISONE |
DATE OF SAMPLING |
JUL.4.2020 |
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BATCH NUMBER |
20200705 |
DATE OF REPORT |
JUL.13.2020 |
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BATCH SIZE |
114.28KG |
RETEST DATE |
JUN.2025 |
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CRITERIA USP42 |
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NAME OF THE TEST |
SPECIFICATION |
RESULTS |
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APPEARANCE |
WHITE TO PRACTICALLY WHITE,CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
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IDENTIFICATION |
IR |
CONFORM |
CONFORM |
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CHEMISTRY REACTION |
CONFORM |
CONFORM |
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ASSAY |
97.0%-102.0% |
98.2% |
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RESIDUE ON IGNITION |
NEGLIGIBLE |
NEGLIGIBLE |
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ORGANIC IMPURITIES |
ANY INDIVIDUAL IMPURITY≤1.5% TOTAL≤2.0% |
THE MAX:0.40% TOTAL:1.3% |
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OPTICAL ROTATION |
+167°-+175° |
+170° |
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WATER |
≤1.0% |
0.1% |
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CONCLUSION:CONFORMS TO USP42 |
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RESIDUAL SOLVENTS |
METHANOL≤3000PPM ACETONE≤5000PPM CHLOROFORM≤60PPM |
NOT DETECTED 1228PPM NOT DETECTED |
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MICRONIZED |
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