Chlorhexidine digluconate 20%


Chlorhexidine bigluconate 20% (chlorhexidine gluconate, chlorhexidine digluconate) solution produced according to USP/BP/EP requirements at GMP certified facility.

This aqueous solution is widely used across the medical, dental, veterinary, cosmetic and dairy industries in the formulation of a broad variety of products, both as a preservative and as an active pharmaceutical ingredient. Chlorhexidine derivatives are is used in more than 50 different pharmaceuticals and medical applications. It provides a broad-spectrum efficacy and substantivity on the skin with low irritation. Chlorhexidine has a strong affinity for binding to skin and mucous membranes and thereby provides prolonged activity. 

Chlorhexidine digluconate solution 20% is supplied in 200 kg drums
5 kg drums are also available by request



SPECIFICATION


Product name:

 

Chlorhexidine gluconate (digluconate) 20% solution

 

Nr

Item

Limits

Reference

1

Appearance

 

Almost colorless or pale yellow clear liquid

 

USP/EP/BP

2

Solubility

 

Miscible with glacial acetic acid and water, miscible three times by its volume with acetone, and five times with dehydrated alcohol, further addition of alcohol or acetone yields a white precipitation

 

USP

 

Miscible with water, with no more than 3 parts of acetoin, and with no more than 5 parts of ethanol (96%)

 

EP/BP

3

Identification tests

A (IR)

 

The IR spectrum from the sample should correspond to reference standard

 

USP/EP/BP

B (TLC)

 

The principal spot obtained from the test solution in similar color, size and Rf value to that obtained from the reference standard solution

 

USP/EP/BP

C (Melting point)

Between 132 °C and 136 °C

USP/EP/BP

D (Analytical test)

A deep red colour should be produced

USP/EP/BP

4

Specific gravity

Between 1.06 and 1.07

USP/EP/BP

5

pH(5% v/v)

Between 5.5 and 7.0

USP/EP/BP

6

Related substance

NMT 3.0%

USP/EP/BP

7

p-Chloraniline

Less than 500 ppm

USP

Less than 50 pp,

In-house statndard

Complies test

EP/BP

8

Assay

NLT 19.0% and NMT 21% of chlorhexidine bigluconate

USP

NLT 190 g/L and NMT 210 g/L of chlorhexidine bigluconate

EP/BP