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喜樹(shù)堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
CERTIFICATE OF ANALYSIS
Product Name
Domperidone
Batch No.
230602
Manu. Date
2023.06.02
Anal. Date
Test Basis
EP7.0
Factory lot number
20230602
ITEMS
SPECIFICATIONS
RESULTS
Appearance
White or almost white powder
White powder
Solubility
Practically insoluble in water, soluble in dimethyl formamide, slightly soluble in alcohol and in methanol
Complies
Identification
A)M.P.
244-248℃
244-246℃
B)TLC Method
Shall comply
C)Non Nitrogen Substituted Barbiturate
Appearance of the solution
Related substance
By HPLC, individual impurity≤0.25%
0.051%,0.058%,0.201%
Total impurity≤0.5%
0.312%
Heavy metals
Not more than 20ppm
Loss on drying
≤0.50%
0.13%
Residue on ignition
≤0.1%
0.06%
Assay
99.0% -101.0%
99.75%
Conclusion
Conform to EP7.0/USP35
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