Description

Clarithromycin Impurity Q (10 Mg) (n-Oxide Clarithromycin) is a specified impurity of the macrolide antibiotic Clarithromycin, identified by CAS NO 118074-07-0. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this oxidative degradation product. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Clarithromycin Impurity Q in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Clarithromycin.
• Stability Studies & Forced Degradation: Used as a marker to study the oxidative degradation pathways and shelf-life stability of Clarithromycin formulations under various stress conditions.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure impurity levels in commercial Clarithromycin batches comply with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities as required by ICH guidelines.
• Research on Degradation Mechanisms: Facilitates academic and industrial research into the chemical behavior, formation, and control of Clarithromycin impurities.

Basic Information

Product Name	Clarithromycin Impurity Q (10 Mg) (n-Oxide Clarithromycin)
CAS No.	118074-07-0
Molecular Formula	C38H69NO14
Molecular Weight	763.96 g/mol
Synonyms	Clarithromycin N-Oxide; 6-O-Methylerythromycin N-Oxide; Clarithromycin Impurity E (EP); Clarithromycin Related Compound Q; Clarithromycin EP Impurity Q; (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 N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Clarithromycin Impurity Q is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results for identity, purity, and related substances. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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