Procaine hydrochloride

Procaine hydrochloride

Item specifics

Appearance
white crystalline powder

Product review

Description

                                 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.