Description

Roxithromycin Ep Impurity J is a specified impurity used in the quality control and analytical research of the macrolide antibiotic, Roxithromycin. This compound is critical for pharmaceutical development and manufacturing, serving as a certified reference standard to ensure product purity, safety, and regulatory compliance. It is primarily utilized by analytical chemists, quality assurance professionals, and research scientists in pharmaceutical companies and contract research organizations (CROs) for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Roxithromycin active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels in Roxithromycin batches, ensuring they meet pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation of degradation products in Roxithromycin under various stress conditions (heat, light, humidity) as part of stability-indicating assays.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization data.
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to identify and understand impurity formation pathways.

Basic Information

Product Name	Roxithromycin Ep Impurity J
CAS No.	134834-12-1
Molecular Formula	C41H76N2O15
Molecular Weight	837.05 g/mol
Synonyms	Roxithromycin Impurity J; Roxithromycin EP Impurity J; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-Ethyl-12,13-dihydroxy-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-7-methoxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione; Roxithromycin Related Compound J
EINECS	Contact for details

Quality Control

Every batch of Roxithromycin EP Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle the material in accordance with good laboratory practices to maintain its stability and integrity as a reference standard.

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)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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