PHR1421

Chlorhexidine

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Chlorhexidine, 1,1′-Hexamethylenebis[5-(4-chlorophenyl)biguanide]
• Linear Formula: [-(CH₂)₃NHC(=NH)NHC(=NH)NHC₆H₄Cl]₂
• CAS Number: 55-56-1
• Molecular Weight: 505.45
• Beilstein/REAXYS Number: 2826432
• EC Number: 200-238-7
• MDL number: MFCD00009673
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823391
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. C1510000; traceable to USP 1111001
• API family: chlorhexidine
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 134-136 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: Clc1ccc(NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)Nc2ccc(Cl)cc2)cc1
• InChI: 1S/C22H30Cl2N10/c23-15-5-9-17(10-6-15)31-21(27)33-19(25)29-13-3-1-2-4-14-30-20(26)34-22(28)32-18-11-7-16(24)8-12-18/h5-12H,1-4,13-14H2,(H5,25,27,29,31,33)(H5,26,28,30,32,34)
• InChI key: GHXZTYHSJHQHIJ-UHFFFAOYSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Chlorhexidine, the most popular antiseptic of biguanides, acts as a potential antimicrobial agent against several gram-positive and a few gram-negative bacteria. It is prescribed as a medicine for the prevention and treatment of the redness, swelling, and bleeding gums associated with gingivitis in humans. It may also be used as a general-purpose disinfectant for cleansing wounds, skin, instrument, and equipment in veterinary applications. Other applications of chlorhexidine include its use as the component of shampoos, ointments, skin and wound cleansers etc.[1]

Application

Chlorhexidine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.[2][3][1][4]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3899 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS05,GHS09
• signalword: Danger
• hcodes: H318,H410
• pcodes: P273 - P280 - P305 + P351 + P338 - P391 - P501
• Hazard Classifications: Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable