PHR1412

Chloramphenicol

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Chloramphenicol, D-(-)-threo-2,2-Dichloro-N-[β-hydroxy-α−(hydroxymethyl)-β-(4-nitrophenyl)ethyl]acetamide, D-(-)-threo-2-Dichloroacetamido-1-(4-nitrophenyl)-1,3-propanediol, D-threo-2,2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-4-nitrophenethyl]acetamide
• EC Number: 200-287-4
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 854; traceable to Ph. Eur. C1200000; traceable to USP 1107004
• API family: chloramphenicol
• CofA: current certificate can be downloaded
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C

Description

General description

Chloramphenicol is a synthetic antibiotic, isolated from strains of Streptomyces venezuelae. It is widely used against gram-positive and gram-negative bacteria, and is used mainly for ophthalmic and veterinary purposes

Application

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.

Biochem/physiol Actions

Mode of Action:Chloramphenicol inhibits bacterial protein synthesis by blocking the peptidyl transferase step by binding to the 50S ribosomal subunit and preventing attachment of aminoacyl tRNA to the ribosome. It also inhibits mitochondrial and chloroplast protein synthesis and ribosomal formation of (p)ppGpp, de-pressing rRNA transcription

Mode of Resistance:Use of chloramphenicol acetyltransferase will acetylate the product and inactivate it.

Antimicrobial Spectrum: This is a broad spectrum antibiotic against gram-positive and gram-negative bacteria, and is used mainly for ophthalmic and veterinary purposes.

Suitability

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

Preparation Note

Stock solutions can be prepared directly in the vial at any recommended concentration. A solution at 50 mg/mL in ethanol yields a clear, very faint, yellow solution. Degradation of chloramphenicol in aqueous solution is catalyzed by general acids and bases. This rate of degradation is independent of the ionic strength and pH.

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 LRAA2476 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08,GHS05
• Signal Word: Danger
• Hazard Statements: H318,H351,H361fd
• Precautionary Statements: P202 - P280 - P305 + P351 + P338 - P308 + P313 - P405 - P501
• Hazard Classifications: Carc. 2 - Eye Dam. 1 - Repr. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable