Description

Dirithromycin Ep Impurity B is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the macrolide antibiotic Dirithromycin by serving as a key marker for impurity profiling and analytical method validation. It is an essential material for quality control laboratories, regulatory affairs, and R&D departments within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Dirithromycin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating chromatographic methods, particularly High-Performance Liquid Chromatography (HPLC) and UPLC.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs), Common Technical Documents (CTDs), and pharmacopoeial monographs (USP, EP).
• Quality Control (QC) & Stability Studies: Used in routine batch release testing and long-term stability studies to monitor impurity levels and ensure product consistency over time.
• Research on Degradation Pathways: Aids in studying the degradation chemistry and stability profile of Dirithromycin under various stress conditions.
• Calibration of Laboratory Equipment: Serves as a precise standard for calibrating analytical instruments to ensure accurate and reproducible results.

Basic Information

Product Name	Dirithromycin Ep Impurity B
CAS No.	869485-36-9
Molecular Formula	C42H78N2O14
Molecular Weight	835.08 g/mol
Synonyms	Dirithromycin Impurity B; Dirithromycin EP Impurity B; Dirithromycin Related Compound B; (9S)-9-Dihydro-9-deoxy-9a-aza-9a-homoerythromycin A; 9a-Aza-9a-homoerythromycin A, 9-deoxy-9-dihydro-; Dirithromycin Impurity (EP); Dirithromycin Process Impurity; Dirithromycin Degradant
EINECS	Contact for details

Quality Control

Every batch of Dirithromycin Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmacopoeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under conditions that minimize exposure to light and atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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