Tetracaine hydrochloride

Categories	Pharmaceutical Excipients&APIS
Appearance	white crystalline powder
Terms of Payment	L/C, D/A, Western Union, T/T, Paypal
Update Time	May 1,2025

Detail Information

CERTIFICATEOF ANALYSIS

Name: Tetracaine HCL BatchNumber: 20191108

Batch Size: 88kg Packing Size: 25kg/drum

Certificate No.:20191108 MFG Date: November 8, 2019

Date of Release: November 10, 2019 Expiry Date: November 7, 2020

ANALYSIS AS PER EP Standard.

Items of Test	Specifications	Result of Test
Appearance	White to almost white,slightly hygroscopic,crystalline powder	white,slightly hygroscopic,crystalline powder
Solubility	Freely soluble in water, soluble in ethanol(96%)	Conforms
IR	Spectrum of the sample should conform with that of reference	Conforms
Identification	Conforms to standard	Conforms
Chloride	Conforms to standard	Conforms
Appearance of solution	Solution should be clear and colourless	Clear and colourless
Ph value	4.5-6.5	5.62
Melting point	About 148℃	Conforms
Heavy metal	≤10ppm	Conforms
Sulphated ash	≤0.1%	0.04%
Loss on drying	≤1.0%	0.04%
Assay	99.0%-101.0%	99.86%
4-aminobenzoic acid	≤0.05%	Not detected
4-(butylamino) benzoic acid	≤0.10%	0.03%
Methyl 4-(butylamino) benzoate	≤0.10%	Not detected
Any other unspeicified impurity	≤0.10%	0.06%
Total impurities	≤0.50%	0.16%

Conclusion: it conforms tothe standard EP.