Description

Erythromycin Impurity 8 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 analytical laboratories, quality control departments, and research institutions in the pharmaceutical industry for method development, validation, and impurity profiling.

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 & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing in QC laboratories to ensure erythromycin products meet stringent pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of erythromycin formulations.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification in regulatory filings (e.g., ANDA, NDA) to health authorities like the FDA and EMA.
• Research & Development: Used in R&D to study the degradation pathways, metabolism, and pharmacokinetics of erythromycin and related macrolide antibiotics.

Basic Information

Product Name	Erythromycin Impurity 8
CAS No.	119665-78-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erythromycin Related Compound A; Erythromycin EP Impurity A; Erythromycin USP Related Compound A; (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 A
EINECS	Contact for details

Quality Control

Our Erythromycin Impurity 8 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided for every lot.

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.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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