Description

Clarithromycin Impurity G is a specified impurity and degradation product of the macrolide antibiotic Clarithromycin. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Clarithromycin API and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clarithromycin Active Pharmaceutical Ingredient (API) and formulations.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Aids in studying the degradation pathways and chemical stability of Clarithromycin.

Basic Information

Product Name	Clarithromycin Impurity G
CAS No.	127182-44-9
Molecular Formula	C38H69NO13
Molecular Weight	747.96 g/mol
Synonyms	6-O-Methylerythromycin A; Clarithromycin Related Compound G; Clarithromycin EP Impurity G; Clarithromycin USP Impurity G; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione
EINECS	Contact for details

Quality Control

Our Clarithromycin Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances. The quality standards are aligned with current pharmacopeial requirements (USP/EP) and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.