Description

Roxithromycin Impurity I is a high-purity chemical reference standard, specifically identified as an impurity of the macrolide antibiotic Roxithromycin. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Roxithromycin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and mass spectrometry methods.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products in Roxithromycin formulations under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Roxithromycin.

Basic Information

Product Name	Roxithromycin Impurity I
CAS No.	425365-66-8
Molecular Formula	C41H76N2O15
Molecular Weight	837.06 g/mol
Synonyms	(9E)-9-{O-[(2-Methoxyethoxy)methyl]oxime}erythromycin; Roxithromycin E-isomer; Roxithromycin Impurity E; (E)-Roxithromycin; Erythromycin 9-[(E)-O-[(2-methoxyethoxy)methyl]oxime]; 9(E)-Roxithromycin; Roxithromycin Related Compound I
EINECS	Contact for details

Quality Control

Every batch of Roxithromycin Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be handled in a dry 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)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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