Description

Roxithromycin Ep Impurity D CAS NO 134931-00-3 is a high-purity chemical reference standard, specifically identified as an impurity of the macrolide antibiotic Roxithromycin. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily used by quality assurance laboratories, regulatory affairs departments, and R&D scientists working on antibiotic development and impurity profiling to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Roxithromycin Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods, primarily HPLC and UPLC, for impurity separation and analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC labs to monitor impurity levels and ensure they remain within ICH (International Council for Harmonisation) specified limits.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies of Roxithromycin to track the formation and behavior of this specific impurity over time.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, pharmacokinetics, and metabolic profile of Roxithromycin.

Basic Information

Product Name	Roxithromycin Ep Impurity D
CAS No.	134931-00-3
Molecular Formula	C41H76N2O15
Molecular Weight	837.06 g/mol
Synonyms	(9E)-9-{O-[(2-Methoxyethoxy)methyl]oxime} of Erythromycin; Roxithromycin Impurity D (EP); Roxithromycin Related Compound D; 9-(E)-O-[(2-Methoxyethoxy)methyl]oxime Erythromycin; Roxithromycin EP Impurity D; Erythromycin 9-[(E)-O-[(2-methoxyethoxy)methyl]oxime]; Roxithromycin Imp D
EINECS	Contact for details

Quality Control

Every batch of Roxithromycin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with European Pharmacopoeia (EP) and other relevant pharmacopeial standards. Comprehensive Certificates of Analysis (COA) detailing results from HPLC, NMR, and MS analyses are provided to guarantee traceability and regulatory readiness for our clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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