Description

Azithromycin Impurity 8 is a specified impurity of the broad-spectrum macrolide antibiotic, Azithromycin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Azithromycin-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Azithromycin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and analyze Azithromycin and its related substances.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Azithromycin, complying with pharmacopeial standards (USP, EP, BP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products in Azithromycin under various stress conditions (heat, light, humidity) as part of stability-indicating methods.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways and stability profile of Azithromycin.

Basic Information

Product Name	Azithromycin Impurity 8
CAS No.	620169-51-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azithromycin Related Compound H; Azithromycin EP Impurity H; Azithromycin USP Related Compound H; (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 H
EINECS	Contact for details

Quality Control

Our Azithromycin Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for purity (by HPLC), identification (by spectroscopic methods), and other relevant tests. We support compliance with major pharmacopeial standards, and specifications can be aligned with client requirements for research or regulatory purposes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
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.