Description

Clarithromycin Ep Impurity F is a critical pharmaceutical reference standard used to ensure the purity and safety of the antibiotic Clarithromycin. This compound is essential for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory compliance. It is primarily utilized by research and development laboratories, quality assurance departments, and regulatory bodies involved in the production and testing of Clarithromycin API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Clarithromycin Ep Impurity F in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Release Testing: A critical component in the routine QC testing of Clarithromycin to ensure compliance with pharmacopoeial limits (EP, USP, ICH).
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate control of impurities.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Clarithromycin.

Basic Information

Product Name	Clarithromycin Ep Impurity F
CAS No.	128940-83-0
Molecular Formula	C38H69NO13
Molecular Weight	747.96 g/mol
Synonyms	6-O-Methylerythromycin A 9-(E)-Oxime; Clarithromycin Impurity F (EP); Clarithromycin Related Compound F; (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; 6-O-Methylerythromycin A 9-(E)-Oxime Impurity; Clarithromycin EP Impurity F
EINECS	Contact for details

Quality Control

Our Clarithromycin Ep Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. The product is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3B(R2) guidelines and relevant pharmacopoeial monographs.

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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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