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喜樹堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
PRODUCT
PREDNISONE
DATE OF SAMPLING
JUL.4.2020
BATCH NUMBER
20200705
DATE OF REPORT
JUL.13.2020
BATCH SIZE
114.28KG
RETEST DATE
JUN.2025
CRITERIA USP42
NAME OF THE TEST
SPECIFICATION
RESULTS
APPEARANCE
WHITE TO PRACTICALLY WHITE,CRYSTALLINE POWDER
WHITE CRYSTALLINE POWDER
IDENTIFICATION
IR
CONFORM
CHEMISTRY REACTION
ASSAY
97.0%-102.0%
98.2%
RESIDUE ON IGNITION
NEGLIGIBLE
ORGANIC IMPURITIES
ANY INDIVIDUAL IMPURITY≤1.5%
TOTAL≤2.0%
THE MAX:0.40%
TOTAL:1.3%
OPTICAL ROTATION
+167°-+175°
+170°
WATER
≤1.0%
0.1%
CONCLUSION:CONFORMS TO USP42
RESIDUAL SOLVENTS
METHANOL≤3000PPM
ACETONE≤5000PPM
CHLOROFORM≤60PPM
NOT DETECTED
1228PPM
MICRONIZED
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