Chlorhexidine Base & Chlorhexidine Gluconate Solution USP BP Ph Eur Manufacturers Exporters

Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturers of Chlorhexidine Base & Chlorhexidine Gluconate Solution, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc.

Aadhunik Industries and/or associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified. We offer crystals granules in precise micron or mesh size as per buyers needs. We offer very high purity standards as per specifications required.

Specifications of Chlorhexidine Base:
Description: White Powder
Melting point: 132- 136C
LOD: NMT 0.5%
Sulphated ash: NMT 0.1%
PCA Content: NMT 100ppm
ASSAY by HPLC: 98-102%.

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).

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.

CAS Number 55-56-1 & 18472-51-0, Chlorhexidine Base & Chlorhexidine Gluconate Solution manufacturers suppliers exporters at:

manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.