Product Portfolio with regulatory compliance

Lidocaine Hydrochloride

Bulk Active : Lidocaine Hydrochloride
Pharmacologic Activity : Local Anaesthetic
CAS No : 6108-05-0
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)

TEST USP 36 BP 2013/EP 7.4
DESCRIPTION White ,odorless, crystalline powder ,having a slightly bitter taste. White or almost white, crystalline powder
SOLUBILITY Very soluble in water and in alcohol; soluble in chloroform; insoluble in ether. Very soluble in water, freely soluble
in ethanol (96%).

Test A:Melting point

Test B: I. R

Test C:

Test D:

Test E:

75°C to 77°C


Infrared absorption spectrophotometry to compare with spectrum obtained with Lidocaine Hcl reference standard


Responds to test for chlorides.

The retention time of the major peak of the sample solution corresponds to that of the standard solution as obtained in the Assay solution of Lidocaine Hydrochloride

74°C to 79°C, determined without previous drying.

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

A green color should be produced.

Confirms to test for chlorides

Appearance of solution ----- Solution S is clear and colorless
pH ----- 4.0-5.5
Related Substance by HPLC
impurity A unspecified impurities
total impurities
----- NMT 0.01 %
for each impurity, NMT 0.10 %
NMT 0.5 %
Heavy metals NMT 20ppm Less than 5 ppm
Water 5.5- 7.0 % w/w 5.5- 7.0 % w/w
Sulphated Ash ----- NMT 0.1%
Residue on ignition
NMT 0.1%
Sulphates NMT 0.1% -----
Assay Between 97.50% to 102.5%
calculated on anhydrous basis
Between 99.0% to 101.0%
calculated on anhydrous basis