Description

Azithromycin Impurity 11 is a designated impurity standard used in the analytical profiling of the macrolide antibiotic, Azithromycin. This compound is critical for pharmaceutical quality control, enabling manufacturers and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards. It is an essential reference material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Azithromycin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Azithromycin meets specifications set by USP, EP, ICH, or other regulatory guidelines.
• Stability Studies: Employed to track the formation of degradation products in Azithromycin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research on Degradation Pathways: Facilitates studies into the chemical stability and degradation mechanisms of Azithromycin.

Basic Information

Product Name	Azithromycin Impurity 11
CAS No.	612534-95-9
Molecular Formula	C38H72N2O12
Molecular Weight	749.00 g/mol
Synonyms	Azithromycin Related Compound J; Azithromycin EP Impurity J; Azithromycin USP Related Compound J; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one; Azithromycin Impurity J
EINECS	Contact for details

Quality Control

Every batch of Azithromycin Impurity 11 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, LC-MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.