Description

Clarithromycin Impurity 1 is a specified impurity of the macrolide antibiotic Clarithromycin, identified by CAS No. 25044-30-8. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical chemists and quality assurance professionals in pharmaceutical manufacturing and regulatory testing laboratories to monitor, identify, and quantify impurities in Clarithromycin active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Clarithromycin Impurity 1 in HPLC, UPLC, and LC-MS analytical methods.
• Method Development and Validation: Essential for developing, optimizing, and validating impurity profiling methods in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC release testing of Clarithromycin API and formulated drug products to ensure impurity levels are within specified limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research and Development: Used in R&D to understand the degradation pathways of Clarithromycin and to synthesize purer batches of the API.

Basic Information

Item	Details
Product Name	Clarithromycin Impurity 1
CAS No.	25044-30-8
Molecular Formula	C38H69NO13
Molecular Weight	747.96 g/mol
Synonyms	6-O-Methylerythromycin A; Clarithromycin EP Impurity A; Clarithromycin Related Compound A; (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; 6-O-Methylerythromycin; Clarithromycin Impurity A (EP)
EINECS	Contact for details

Quality Control

Every batch of Clarithromycin Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results against predefined specifications. Our quality standards align with the requirements for pharmaceutical reference materials.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.