Description

Erythromycin Impurity 9 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-based pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining the highest standards in drug manufacturing and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Erythromycin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and investigational new drug applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in erythromycin formulations.
• Pharmacopoeial Testing: Used to comply with testing protocols outlined in pharmacopoeias such as USP, EP, and BP for erythromycin substances.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry and metabolic pathway research related to macrolide antibiotics.

Basic Information

Product Name	Erythromycin Impurity 9
CAS No.	58781-38-7
Molecular Formula	C37H67NO13
Molecular Weight	733.93 g/mol
Synonyms	Erythromycin B, 6-O-Methylerythromycin A; Erythromycin B N-oxide; (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 Impurity B; 6-O-Methylerythromycin A N-oxide
EINECS	Contact for details

Quality Control

Every batch of Erythromycin Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and precise impurity profiling requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and analytical results. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopoeial standards.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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