Description

Roxithromycin Ep Impurity E is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the macrolide antibiotic, Roxithromycin, by enabling the accurate identification and quantification of specific process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams involved in the development and manufacturing of antibiotic formulations. The precise characterization of such impurities is fundamental to meeting stringent pharmacopeial standards for drug substance purity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Roxithromycin Ep Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor and control impurity levels during Roxithromycin API synthesis to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions & Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies and specification justifications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Research on Degradation Pathways: Aids academic and industrial researchers in elucidating the chemical degradation pathways and mechanisms of Roxithromycin.

Basic Information

Product Name	Roxithromycin Ep Impurity E
CAS No.	1460313-66-9
Molecular Formula	C41H76N2O15
Molecular Weight	837.06 g/mol
Synonyms	(9E)-9-{O-[(2-Methoxyethoxy)methyl]oxime} of Roxithromycin; Roxithromycin E Isomer; Roxithromycin Impurity E (EP); (E)-Roxithromycin Oxime Ether; Roxithromycin Related Compound E; 9-(E)-O-(2-Methoxyethoxymethyl)oxime Roxithromycin; Erythromycin 9-[(E)-O-[2-(Methoxyethoxy)methyl]oxime], 3''-Acetyl-4''-isovaleryl Derivative
EINECS	Contact for details

Quality Control

Every batch of Roxithromycin Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, assay, and identification, is provided with each shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere in a desiccator 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%
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

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