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Disinfectant and AntisepticsChlorhexidine Base

General Info :

CAS Number Molecular Formula Molecular Weight
55-56-1 C22H30Cl2N10 505.46 gm/mol

Sales Specification :

Avichlorhex - B (Chlorhexidine Base)

Parameter Avichlorhex - B Specification Reference
Description White or almost white powder In-house
Solubility It dissolves in hot n-Butanol and Mineral acid; Very slightly soluble in Methanol; Practically in soluble in water In-house
Identification
A) IR A) IR spectrum of the test sample should be concordant with that of Chlorhexidine working standard EP
B) Melting Range B) Between 132°C -136°C EP
C) Color test C) A deep red color produced In-House
Loss on drying Not More Than 1.0 % w/w EP
Sulphated Ash Not More Than 0.1 % w/w EP
P-Chloroaniline Not More Than 500 ppm EP
Assay 98 % to 102 % on dried basis In-house
Related Substance (by HPLC)
Chlorhexidine oxazinone analog Not more than 0.2 % USP
Specified unidentified impurity-1 Not more than 0.2 % USP
Chlorhexidine Amine Not more than 0.3 % USP
Chlorhexidine guanidine Not more than 1.0 % USP
Chlorhexidine urea Not more than 0.2 % USP
p-Chlorophenyl urea Not more than 0.2 % USP
Chlorhexidine nitrile Not more than 0.4 % USP
Chlorhexidine dimer Not more than 0.5 % USP
o- Chlorhexidine and specified unidentified impurity-2 Not more than 0.4 % USP
Chlorhexidine glucityl triazine Not more than 0.4 % USP
Oxochlorhexidine Not more than 0.4 % USP
Any individual Unspecified imp. Not more than 0.10 % USP
Total impurities Not more than 1.5 % USP
Additional Test
Residual Solvents
1) Methanol
2) n-Butanol
3) Benzene

NMT 3000 ppm
NMT 5000 ppm
NMT 2 ppm

IH

Market Applications :

  • Chlorhexidine is used in disinfectants (disinfection of the skin and hands), cosmetics (additive to creams, toothpaste, deodorants, and antiperspirants), and pharmaceutical products (preservative in eye drops, active substance in wound dressings and antiseptic mouthwashes).

Disinfectant and AntisepticsChlorhexidine Digluconate

Sales Specification :

Avichlorhex- G (Chlorhexidine Digluconate)

Parameter Avichlorhex- G Specification (USP) Avichlorhex- G Specification (EP) Avichlorhex- G Specification (IP) Avichlorhex- G Specification (BP)
Description Almost colourless or pale yellowish liquid. Almost colourless or pale yellowish liquid. Almost colourless or pale yellowish liquid. Almost colourless or pale yellowish liquid.
Solubility in water Miscible. Miscible. Miscible. Miscible.
Identification
A)I.R. IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard IR spectrum of the test sample should be concordant with that of Chlorhexidine Digluconate working standard
B) Relative Density 1.06 – 1.07 1.06 – 1.07 1.06 – 1.07 1.06 – 1.07
C) pH (5% v/v Solution) 5.5 to 7.0. 5.5 to 7.0. 5.5 to 7.0. 5.5 to 7.0.
Loss on drying Maximum 1.0 % w/w. Maximum 1.0 % w/w Maximum 1.0 % w/w Maximum 1.0 % w/w
Sulphated Ash Maximum 0.1 % w/w Maximum 0.1 % w/w Maximum 0.1 % w/w Maximum 0.1 % w/w
Related substance NMT 3% NMT 3% NMT 3% NMT 3%
Chlorhexidine oxazinone analogue NMT 0.2% As per EP As per IP As per BP
Impurity N NMT 1.0%
Specified unidentified impurity 1 NMT 0.2% Impurity H NMT 0.50%
Chlorhexidine amine NMT 0.3% Impurity A NMT 0.40%
Chlorhexidine guanidine NMT 1.0% Impurity J NMT 0.40%
Chlorhexidine urea NMT 02% Impurity K NMT 0.40%
ρ-Clorophenyl urea NMT 0.2% Sum of Impurities I&O NMT 0.40%
Chlorhexidine nitrile NMT 0.4% Impurity G NMT 0.30%
ο-Chlorhexidine and specified unidentified impurity 2 NMT 0.2% Impurity B NMT 0.20%
Chlorhexidine glucityl triazine NMT 0.2% Impurity F NMT 0.20%
Oxochlorhexidine NMT 0.2% Impurity L NMT 0.20%
Any individual unspecified impurity NMT 0.2% Impurity Q NMT 0.20%
Unspecified
Impurities NMT 0.10%
Limit of p-Chloroaniline NMT 500 ppm NMT 100 ppm
Total impurities NMT 3.0% Total impurities NMT 3.0% Total impurities NMT 3.0% Total impurities NMT 3.0% Total impurities NMT 3.0%
Assay (by potentiometrically) Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate) Chlorhexidine Digluconate solution is an aqueous solution which contains NLT 190 g/L and NMT 210 g/L 1,1’-Hexamethylene-[5-(4-Chlorophenyl)-Biguanide]di(D-Digluconate)

Market Applications :



Topical use

  • Surgical scrub and antiseptic hand rinse for healthcare personnel.
  • Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients.

Oral use

  • Oral rinse: 0.12% Antibacterial dental rinse for gingivitis treatment
  • Periodontal chip: Adjunctive therapy to reduce pocket depth in patients with periodontitis.

Veterinary use

  • Effective protection against Mastitis by cows.
  • Used in the general dairy hygiene of milk producing animals.
  • Typical concentration as antiseptic is 0.5 – 4% of Chlorhexidine Di Gluconate.

Disinfectant and AntisepticsChlorhexidine Diacetate

General Info :

CAS Number Molecular Formula Molecular Weight
56-40-6 C22H30Cl2N10·2(C2H4O2) 625.5 gm/mol

Sales Specification :

Avichlorhex - A (Chlorhexidine Diacetate)

Parameter Avichlorhex - A Specification
Appearance A white to off white powder
Identification
By I.R. The IR spectrum complies with the IR spectrum of reference standard of chlorhexidine Diacetate
Melting Point 153.0°C to 157.0°C
Residue on ignition Not more than 0.15%
Related Substances p-chloroaniline Total Impurities NMT 200 ppm
NMT 3%
Loss on drying Not more than 3.50%
Assay (On dried basis) Not less than 98.0% and not more than 101.0%
Residual Solvent (By GC) Methanoln-Butanol NMT 3000 ppm
NMT 3000 ppm

Market Applications :

Disinfectant

  • General Disinfection of equipment, surfaces and textiles

Veterinary uses

  • Chlorhexidine Acetate is also used for many veterinary applications in certain geographical areas instead of Chlorhexidine Di Gluconate

Others

  • Chlorhexidine Acetate is used to manufacture antacid tablets.

Disinfectant and AntisepticsChlorhexidine Dihydrochloride

General Info :

CAS No Molecular Formula Molecular Weight
1308292-89-8 C22H32Cl4N10 468.81 gm/mol

Sales Specification :

Avichlorhex - H (Chlorhexidine Dihydrochloride)

Parameter Avichlorhex - H Specification
Appearance White or almost white crystalline powder
Solubility Sparingly soluble in water and in propylene glycol, very slightly soluble in ethanol (96 per cent).
Identification by IR The IR spectrum complies with the IR spectrum of reference standard of chlorhexidine Diacetate.
Melting Point 255-259 0C
Related Substances p-chloroaniline Total Impurities NMT 200 ppm
NMT 2.5%
Assay (On dried basis) Not less than 98.0% and not more than 101.0%.
Residual Solvent (By GC) Methanol n-Butanol NMT 3000 ppm
NMT 3000 ppm

Market Applications :

Antiseptic

  • Chlorhexidine hydrochloride is used typically in combination with other API’s as sore throat tablets

Disinfectant

  • Chlorhexidine hydrochloride is used as disinfectant for peripherally inserted central catheters (PICC’s) or central venous catheters (CVC’s)

Preservative

  • In the cosmetic field Chlorhexidine hydrochloride is used as a preservative in creams, ointments and gels.


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