Description

Vancomycin Didechloro Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the glycopeptide antibiotic Vancomycin. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and compliance testing for antibiotic production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Vancomycin API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Vancomycin meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand drug decomposition pathways.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry and metabolic studies to investigate the structure-activity relationships and degradation mechanisms of Vancomycin.

Basic Information

Product Name	Vancomycin Didechloro Impurity
CAS No.	98510-30-6
Molecular Formula	C66H75Cl2N9O24
Molecular Weight	1449.2 g/mol
Synonyms	Vancomycin Didechloro; Deschlorovancomycin; Vancomycin Impurity Didechloro; (3S,6R,7R,22R,23S,26S,36R,38aS)-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)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid; Vancomycin related compound Didechloro
EINECS	Contact for details

Quality Control

Every batch of Vancomycin Didechloro Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (Mass Spectrometry)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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