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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
Vincristine Sulphate USP
Batch number
20220816
Manufacture date
2022.08.28
Batch size
200g
Test date
2022.09.10
quantity
188.96g
Report date
2022.09.20
Reference
USP
Retest date
2024.08.27
Items
Specification
Result
characters
Appearance
White or slightly yellowish.powder very hygroscopic.
White powder
Solubility
Freely soluble in water,soluble in methanol,slightly soluble in alcohol.
Conforms
Identification
A .infrared absorption
The IR spectrum of the substance to be examined corresponds to that of the Ph.Eur.reference spectrum of vincristine sulphate.
B.Reaction of sulphate
Positive for sulphate
Positive
Tests
pH
3.5~4.5(1.0mg/ml in water)
4.5
Related substances
Other individual impurities:≤1.0%
0.41%
Total inpurity:≤4.0%
1.9%
Residual organic solvent
Methanol:≤3000ppm
64ppm
Ethanol :≤5000ppm
2597ppm
Chloroform:≤600ppm
182ppm
Chloroform:≤60ppm
48ppm
Tetrahydrofuran:≤720ppm
5ppm
Loss on drying
≤12.0%
6.4%
Bacterial endotoxins
≤20EU/mg
Microbial limit
Total viable acrobic count (acrobic bacteria plus fungi):≤100CFU/g
10CFU/g
Psendomonas aeruginosa:Absence/g
Absence/g
Staphylococcus aurens:Absence/g
Enterobacteria:Absence/g
Assay
95.0%~104.0%(calculated with reference to the dried substance.)
98.0%
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