Description

Clarithromycin Impurity Ep G is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antibiotic clarithromycin by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and quality control laboratories. The precise characterization of such impurities is fundamental to meeting stringent pharmacopeial standards for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clarithromycin Impurity Ep G in clarithromycin API and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure clarithromycin meets specifications set by pharmacopeias like USP, EP, and ICH guidelines (specifically ICH Q3A/B).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control over the manufacturing process.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during synthesis, helping to refine manufacturing processes to minimize its generation.

Basic Information

Item	Detail
Product Name	Clarithromycin Impurity Ep G
CAS No.	107216-09-1
Molecular Formula	C38H69NO13
Molecular Weight	747.96 g/mol
Synonyms	6-O-Methylerythromycin E; Clarithromycin EP Impurity G; Clarithromycin Related Compound 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

Every batch of Clarithromycin Impurity Ep G is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability and purity.

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, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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