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CERTIFICATE OF ANALYSIS
Product Name |
Procaine hydrochloride |
Batch No. |
230103 |
Quantity |
100 KG |
MFG. Date |
Jan. 03,2023 |
Exp. Date |
Jan. 03,,2026 |
Specification |
Usp 36 |
ITEMS |
SPECIFICATIONS |
RESULTS |
|
Characters |
White crystalline powder |
Conform |
|
Identification |
A,B,C.it happears positive reaction |
Conform |
|
Melting rang |
(153~158℃) |
155.0℃ |
|
Heavy metals |
≤0.002% |
<5ppm |
|
Acidity |
5.0~6.5 (≤0.02NNaOH0.5ml) |
5.50/0.3ml |
|
Chromatographic purity |
Secondary spots≤0.5%,sum≤1.0% |
Conforms |
|
Loss on drying |
≤1.0% |
0.06% |
|
Residue on ignition |
≤0.15% |
0.03% |
|
Assay (C13H20N2O2﹣HCl) |
99.0~101.0% |
99.78% |
|
Bacterial endotoxins |
≤0.6EU/mg |
<0.6EU/mg |
|
Conclusion |
The sample is Procaine Hydrochloride and meets the specification of usp36 |