Description

Vancomycin Ep Impurity B is a high-purity reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the development and manufacturing of the antibiotic Vancomycin. It is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical companies and contract research organizations (CROs) to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC laboratories.
• Method Development and Validation: Used to develop and validate precise HPLC, UPLC, or LC-MS methods for impurity profiling of Vancomycin API and finished drug products.
• Stability Studies: Employed as a marker to track the formation of degradation products in Vancomycin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by identifying and minimizing the formation of this specific impurity.
• Academic and Clinical Research: Supports investigative studies on the pharmacokinetics, metabolism, and structure-activity relationships of Vancomycin and its related compounds.

Basic Information

Item	Details
Product Name	Vancomycin Ep Impurity B
CAS No.	555598-85-1
Molecular Formula	C66H75Cl2N9O24
Molecular Weight	1445.2 g/mol
Synonyms	Vancomycin EP Impurity B; Vancomycin Impurity B (EP); (3S,6R,7R,22R,23S,26S,36S,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[2-[(1-iminoethyl)amino]ethyl]carbamoyl]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,34-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid; Vancomycin related compound B.
EINECS	Contact for details

Quality Control

Every batch of Vancomycin Ep Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research needs.

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 must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
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.