Description

Clarithromycin Impurity H is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Clarithromycin during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams for method validation, impurity profiling, and stability studies.

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 finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels in compliance with ICH guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays for batch release.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the US FDA, EMA, and others.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Clarithromycin.

Basic Information

Product Name	Clarithromycin Impurity H
CAS No.	127140-69-6
Molecular Formula	C38H69NO13
Molecular Weight	747.96 g/mol
Synonyms	6-O-Methylerythromycin A 9-oxime; Clarithromycin EP Impurity H; Clarithromycin Related Compound H; (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-oxime
EINECS	Contact for details

Quality Control

Our Clarithromycin Impurity H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment 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)	≥ 95.0%
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.