CERTIFICATE OF ANALYSIS
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PRODUCT: PREDNICARBATE
BATCH NO.: 20181003 DATE OF MFG.: OCT.23,2018
DATE OF ISSUE: OCT.23, 2018 REPORT NO．： 2018102309
APPEARANCE: WHITE OR ALMOST WHITE POWDER
TESTING ITEM SPECIFICATIONS RESULTS
IDENTIFICATION
1)IR POSITIVE POSITIVE
2)TLC POSTIVIE POSITIVE
LOSS ON DRYING 0.5%MAX 0.12%
OPTICAL ROTATION +60°~+66° +64.17°
RELATED SUBSTANCES(HPLC)
IMPURITY B 0.2%MAX 0.017%
IMPURITY C 0.5%MAX 0.200%
IMPURITY D 0.2%MAX 0.038%
IMPURITY E 0.3%MAX 0.108%
IMPURITY F 0.8%MAX 0.103%
EACH IMPURITY 0.1%MAX 0.039%
TOTAL IMPURITY 2.0%MAX 0.427%
ASSAY 97.0%~102.0% 99.44%
RESIDUAL SOLVENT
IPA 5000PPM MAX N.D
N-HEXANE 290PPM MAX 58 PPM
EA 5000PPM MAX 372 PPM
CHLOROFORM 60PPM MAX N.D
ACETIC ACID 5000PP MAX N.D
PYRIDINE 200PPM MAX N.D
STORAGE CONDITION: PRESEVE IN HERMETICALLY SEALED CONTAINERS,
PROTECED FROM LIGHT, STORED IN A COOL AND DRY PLACE.
关键字： Prednicarbate;泼尼卡松;73771-04-7;泼尼卡酯原料药;
从事生物工程产品器械研发和销售，进出口植物提取物，医药原料药