Description

Erythromycin Ep Impurity M CAS NO 616234-56-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Erythromycin active pharmaceutical ingredients (APIs) and related formulations. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopoeial guidelines.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of Erythromycin Ep Impurity M in Erythromycin API and drug products.
• Analytical Method Development and Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Erythromycin analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor impurity levels against ICH Q3A/B and pharmacopoeial (USP, EP, BP) specifications.
• Stability Studies: Acts as a marker to track the formation of specific degradation products under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CEP) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in R&D to study the degradation pathways, metabolism, and chemical behavior of Erythromycin.

Basic Information

Item	Details
Product Name	Erythromycin Ep Impurity M
CAS No.	616234-56-1
Molecular Formula	C37H67NO13
Molecular Weight	733.93 g/mol
Synonyms	Erythromycin EPO Impurity M; Erythromycin Impurity M; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione; Erythromycin related compound M
EINECS	Contact for details

Quality Control

Our Erythromycin Ep Impurity M is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH guidelines and relevant pharmacopoeial 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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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