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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
CERTIFICATE OF ANALYSIS
PRODUCT:
Methylprednisolone Acetate
ANALYSIS DATE:
2020-9-5
BATCH NO:
2009001
DATE OF MANUFACTURING:
2020-9-1
RETEST DATE:
2023-8-31
QUANTITY:
10KG
Packing
/
DATE OF
REEVALUATION:
DATE OF EXPIRY:
STANDARD:
USP40
ITEM AND RESULT
Item
Test based on
specification
Result
Appearance
White or almost white
Crystalline powder
white crystalline powder
Identification
A.IR
B.UV
Complies
Specific rotation
+97°~+105°
+100.57°
Loss on drying
≤1.0%
0.12%
Chromatographic purity
Single impurity≤1.0%
0.58%
Total impurities≤2.0%
0.84%
Particle size(um)
90%≤20um
Assay
97.0%~103.0%
98.97%
Conclusion
Complies USP40 standard
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