Product Portfolio with regulatory compliance

Lidocaine

Bulk Active : Lidocaine
MOLECULAR FORMULA : C14H22N2O
MOLECULAR WEIGHT : 234.3
Pharmacologic Activity : Local Anaesthetic
CAS No : 137-58-6
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)

TEST USP 36 BP 2013/EP 7.4
     
CHARACTERS White or slightly yellow, crystalline powder.
Has a characteristic odor and is stable in air
White or almost white, crystalline powder
     
SOLUBILITY Very soluble in alcohol and in chloroform; freely soluble in benzene and in ether ; Practically insoluble in water Dissolves in oils. practically insoluble in water, very soluble in ethanol 96% and in methylene chloride.
     

IDENTIFICATION
Test A: I R



Test B:
Melting point


Test C:





Infrared absorption spectrophotometry to compare with the spectrum obtained with lidocaine CRS.

-----



The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay



Infrared absorption spectrophotometry to compare with the spectrum obtained with lidocaine CRS.

66°C to 70°C. determined without
previous drying


A green color should be produced.

It complies with the water test

     
Related Substance by HPLC
impurity A unspecified impurities
total impurities
----- NMT 0.01 %
for each impurity, NMT 0.10 %

NMT 0.5 %
     
Chlorides NMT 35 ppm NMT 35ppm
     
Sulphates NMT 0.1% NNMT 0.1%
     
Water ----- NMT 1.0% % w/w
     
Residue on ignition NMT 0.1% -----
     
Heavy metals Less than 20 ppm -----
     
Sulphated Ash
-----
NMT 0.1%
     
Assay Between 97.5% to 102.50% Between 99.0% to 101.0%
calculated on anhydrous basis