Procaine hydrochloride
Item specifics
- Appearance
- white crystalline powder
Review
Description
CERTIFICATE OF ANALYSIS
Product Name: ProcaineHydrochloride
MFG Date: July 10, 2019 Analysis Date: July 11, 2019
Retest Date: July 10, 2020
ANALYSIS AS PER USP 34 STANDARD.
Items of Test | Specifications | Result of Test |
Appearance | A white or almost white crystalline powder or colorless crystals | Conforms |
Identification | IR: infrared absorption spectrophotometer accord with the procaine hydrochloride CRS Chemistry reaction: Appears a positive reaction Chlorides reaction: it gives reaction of chlorides | Conforms
Conforms Conforms |
Melting point | 153 | 155.7 |
Chromatographic purity | Any impurity: ≤0.5% Total impurities ≤1.0% | Conforms Conforms |
Residue on ignition | ≤ 0.15% | 0.01% |
Loss on drying | ≤ 1.0% | 0.07% |
Heavy metals | ≤20ppm | <20ppm |
Assay | 99.0%-101.0% | 99.93% |
Acidity | ≤0.5ml NaOH(0.02mol/ml) | 0.20ml |
Residual solvents | Ethanol ≤5000ppm Dimethylbenzene | 147ppm Not detected |
Bacterial endotoxins | ≤0.6EU/mg | Conforms |
Microbial limited | Meets the specifications | Conforms |
Sterility | N/A | N/A |