Chlorhexidine Gluconate Solution

Chlorhexidine gluconate (CHG), is a disinfectant and antiseptic that is used for skin disinfection before surgery and to sterilize surgical instruments. It is used as a liquid or powder for several pharmaceutical and industrial purpose.

Properties and General Specifications of Chlorhexidine Gluconate solution or Chlorhexidine Digluconate solution:
Appearance: Colorless to faint yellow liquid.
pH: 5.5 to 7
Turbidity: Clear.
Assay: 20% in water.
Chloroaniline: Not more than 0.25 % (with reference to Chlorhexidine digluconate at a nominal concentration of 200 g/l).
Related substance: Not more than 3%
Relative density: 1.06 to 1.07
Solubility: Chlorhexidine Gluconate is miscible with water, with not more than 3 parts of acetone and with not more than 5 parts of ethanol (96 per cent).

Specifications of Chlorhexidine Gluconate Solution USP Grade:
C22H30Cl2N10-2C6H12O7 --- 897.77
2,4,11,13-Tetraazatetradecanediimidamide, N, N′′-bis(4-chlorophenyl)-3,12-diimino-, di-Dgluconate.
1,1′-Hexamethylenebis[5-(p-chlorophenyl)biguanide] di-D-gluconate [CAS 18472-51-0].

Chlorhexidine Gluconate Solution is an aqueous solution of chlorhexidine gluconate. It contains not less than 19.0 percent and not more than 21.0 percent of C22H30Cl2N10·2C6H12O7 (w/v).
Packaging and storage: Preserve in tight containers, protected from light, at controlled room temperature.

Identification:
A: Infrared Absorption: To pass the test.
Recrystallize this solution and dry the crystals at 105 for 1 hour.
B: The crystals obtained in Identification test A melt between 132C and 136C.
C: To 0.05 mL of Solution add 5 mL of a solution of cetyltrimethylammonium bromide (1 in 100), 1 mL of 10 N sodium hydroxide, and 1 mL of bromine: a deep red color is produced.
D: Chromatographic test: To pass the test.
Specific gravity: between 1.06 and 1.07.
pH: between 5.5 and 7.0, when diluted 1 in 20 with water.
Related compounds: To pass the test.
Limit of p-chloroaniline: To pass the test.

Specifications of Chlorhexidine Gluconate Solution BP Ph Eur Grade:
C34H54Cl2N10O14 --- 898 --- CAS 18472-51-0
Action and use: Antiseptic.

DEFINITION
Aqueous solution of 1,1′-(hexane-1,6-diyl)bis[5-(4-chlorophenyl)biguanide] di-d-gluconate.
Content: 190 g/L to 210 g/L.

CHARACTERS
Appearance: Almost colourless or pale-yellowish liquid.
Solubility: Miscible with water, with not more than 3 parts of acetone and with not more than 5 parts of ethanol (96 per cent).

IDENTIFICATION
First identification: A, B
Second identification: B, C, D
A. Infrared absorption spectrophotometry.
B. Thin-layer chromatography. To pass the test.
Results: The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.
C. To 1 mL add 40 mL of water, cool in iced water, make alkaline to titan yellow paper by adding dropwise, and with stirring, strong sodium hydroxide solution and add 1 mL in excess. Filter and wash the precipitate with water until the washings are free from alkali and recrystallise from ethanol (70 per cent V/V). Dry at 100C-105C. The residue melts at 132C to 136C.
D. To 0.05 mL add 5 mL of a 10 g/L solution of cetrimide, 1 mL of strong sodium hydroxide solution and 1 mL of bromine water; a deep red colour is produced.

TESTS
Relative density: 1.06 to 1.07.
pH: 5.5 to 7.0.
Dilute 5.0 mL to 100 mL with carbon dioxide-free water.
Impurity P (chloroaniline): Maximum 500 ppm, calculated with reference to chlorhexidine digluconate solution.
Related substances: To pass the test.

ASSAY
Determine the density of the preparation to be examined. Transfer 1.00 g to a 250 mL beaker and add 50 mL of anhydrous acetic acid. Titrate with 0.1 M perchloric acid, determining the end point potentiometrically.
1 mL of 0.1 M perchloric acid is equivalent to 22.44 mg of C34H54Cl2N10O14.

STORAGE
Protected from light.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.