Chlorhexidine Gluconate Manufacturer in India

Chlorhexidine Gluconate (CHG) 20% (USP/EP/BP/IP)

  • CHG 20% is a commonly used disinfectant approved by FDA more than 40 years ago
  • Prescription mouthwash
  • Surgical preparation for skin
  • Antibacterial soap and skin cleanser

SALIENT FEATURES:

  • Manufactured in a dedicated facility in a humidity-controlled environment
  • US DMF approved, routinely inspected by US FDA
  • Stock maintained globally
  • Manufactured throughout the year offering supply security

Uses +

Definition of Antiseptic (Anti-Infective Agents, Local)
Substances used on humans and animals that destroy harmful microorganisms or inhibit their activity.

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

REGULATORY STATUS +

API (Ph. Eur.)

CEP (Certificate of suitability of monographs of the European Pharmacopoeia) issued R1-CEP 2006-171-REV 02
EU-GMP (Good Manufacturing Practice)
DMF (Drug Master File) issued 2006 No.21946
Biocidal use (Art 95)

RN Laboratories is allowed to sell chlorhexidine digluconate as a biocidal active under Art 95 through an approved letter of access to the original dossier of Evonik/Medichem for the following product types:
Product type 1: Human hygiene biocidal products
Product type 2: Private area and health are disinfectants
Product type 3: Veterinary hygiene biocidal products
Cosmetic

Chlorhexidine digluconate is registered under REACH No. 01-2119946568-22-0005
Chlorhexidine digluconate is registered in the CosIng (Cosmetic Ingredient Database).
This means that it can be used in cosmetics as a preservative with a maximum concentration of 0.3%.

CHEMICAL DETAILS +

Description: Local Anti-infectives, Miscellaneous

IUPAC Name: (1E)-2-[6-[[amino-[(E)-[amino-(4-chloroanilino)methylidene]amino]methylidene]amino]hexyl]-1-[amino-(4-chloroanilino)methylidene]guanidine;(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid

Synonyms: Chlorhexidine Digluconate

Molecular Formula: C22H30Cl2N10•2C6H12O7

Molecular Mass: 897.762 g/mol

CAS Number: 18472-51-0