Procaine hydrochloride

Categories	Pharmaceutical Excipients&APIS
Appearance	white crystalline powder
Terms of Payment	L/C, D/A, Western Union, T/T, Paypal
Update Time	Apr 27,2024

Detail Information

CERTIFICATE OF ANALYSIS

Product Name: ProcaineHydrochloride BatchSize: 25KGS/drum

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	153-158℃	155.7-156.1℃
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

Conclusion: It meets the USP 34 standard.