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CERTIFICATE OF ANALYSIS
|
Product Name |
Praziquantel |
Batch No. |
20220309 |
|
Batch Quantity |
100KG |
Net Weight |
25KG/drum |
|
MFG. Date |
Mar.09，2022 |
Exp. Date |
Mar.08，2024 |
|
Analysis Date |
Mar.10，2022 |
Report Date |
Mar.10，2022 |
|
Pharmacopoeial Standard |
USP32 |
||
|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
|
Characters |
White or practically white crystalline powder |
complies |
|
|
Solubility |
Very slight soluble in water，freely soluble in alcohol and in chloroform |
complies |
|
|
Identification |
IR：Corresponding to Praziquantel CRS |
Positive |
|
|
Melting Range |
136℃~142℃ |
138.6℃~140.2℃ |
|
|
Heavy metals |
Not more than 0.002% |
＜0.002% |
|
|
Phosphate |
Not more than 0.005% |
＜0.05% |
|
|
Loss on drying |
Not more than 0.5% |
0.12% |
|
|
Residue on ignition |
Not more than 0.1% |
0.03% |
|
|
Related Substances |
Relate compound A：not more than 0.2% Relate compound B：not more than 0.2% Relate compound C：not more than 0.2% |
A：0.05% B：0.08% C：Not detectable |
|
|
Assay |
98.5%~101.0% （dried basis） |
99.80% |
|
|
Residual Solvents |
Limit of chloroform：NMT 60ppm Limit of acetone:：NMT 500ppm |
NMT 60ppm NMT 500ppm |
|
|
Conclusion |
Conform with USP32 |
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