Description

Spiramycin Ep Impurity B CAS NO 249930-66-3 is a high-purity chemical reference standard specifically identified as a known impurity of the macrolide antibiotic Spiramycin. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control processes. It is an essential material for analytical chemists, quality assurance professionals, and regulatory affairs specialists working in pharmaceutical manufacturing and contract research organizations to ensure drug safety and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Spiramycin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for the accurate quantification of impurities.
• Quality Control & Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker to track the formation of degradation products in Spiramycin formulations under various stress conditions.
• Pharmacopeial Testing: Used to verify compliance with monographs in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international standards.

Basic Information

Product Name	Spiramycin Ep Impurity B
CAS No.	249930-66-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Spiramycin Impurity B; Spiramycin Related Compound B; Spiramycin EP Impurity B; Spiramycin European Pharmacopoeia Impurity B; Antibiotic Impurity B of Spiramycin; Foromacidin D Impurity; (3R,4S,5S,6R,8R,9R,10E,12E,15R)-5-[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-4-hydroxy-3-methoxy-9,15-dimethyl-1-oxacyclopentadeca-10,12-dien-2,6,8-trione (tentative IUPAC)
EINECS	Contact for details

Quality Control

Every batch of Spiramycin EP Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the exacting requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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