Description

Clarthromycin Ep Impurity B CAS NO 299409-85-1 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 purity, safety, and efficacy of clarithromycin, a widely used macrolide antibiotic, by serving as a known impurity marker. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and regulatory compliance. The accurate identification and quantification of this impurity are fundamental to meeting stringent pharmacopoeial standards for drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in clarithromycin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure clarithromycin products comply with pharmacopoeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in clarithromycin under various stress conditions (heat, light, humidity).
• 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 chemists in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Clarthromycin Ep Impurity B
CAS No.	299409-85-1
Molecular Formula	C38H69NO13
Molecular Weight	747.96 g/mol
Synonyms	Clarithromycin EP Impurity B; Clarithromycin Impurity B; 6-O-Methylerythromycin 9-(E)-O-(2-methoxyethoxy)methyloxime; (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 9-(E)-(O-(2-Methoxyethyl)methyloxime); Clarithromycin Related Compound B
EINECS	Contact for details

Quality Control

Our Clarthromycin Ep Impurity B is manufactured under strict quality systems to ensure it meets the exacting requirements for use as a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. The material is suitable for use in methods compliant with USP, EP, ICH, and other international regulatory guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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