Description

Vecuronium Bromide EP Impurity F is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is specifically used for the identification, quantification, and monitoring of related substances in Vecuronium Bromide active pharmaceutical ingredient (API) batches. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, ensuring compliance with stringent pharmacopeial monographs from the European Pharmacopoeia (EP) and other regulatory bodies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine testing in API quality control laboratories.
• Analytical Method Development: Crucial for developing and optimizing HPLC, UPLC, or LC-MS methods for the separation and detection of Vecuronium Bromide impurities.
• Pharmacopeial Compliance: Used to ensure API batches meet the strict impurity limits specified in the European Pharmacopoeia (EP) and other international pharmacopeias.
• Stability Studies: Employed as a marker to track degradation products in Vecuronium Bromide formulations under various stress conditions.
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs) and regulatory dossiers by providing characterized impurity data.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity profiles during the manufacturing process of the neuromuscular blocking agent.

Basic Information

Product Name	Vecuronium Bromide EP Impurity F
CAS No.	18668-29-6
Molecular Formula	C34H57BrN2O4
Molecular Weight	637.74 g/mol
Synonyms	1-[(2β,3α,5α,16β)-3,17-Bis(acetyloxy)-2-(1-piperidinyl)androstan-16-yl]-1-methylpiperidinium Bromide; Vecuronium Bromide Impurity F; Norcuron Impurity F; 3'-Desacetylvecuronium Bromide; 16-N-Desmethylvecuronium Bromide; Pancuronium Bromide Derivative; Vecuronium Related Compound F; (2β,3α,5α,16β)-2-(1-Piperidinyl)androstane-3,16,17-triol 3,17-diacetate methobromide
EINECS	Contact for details

Quality Control

Every batch of Vecuronium Bromide EP Impurity F is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing assay results, impurity profiles, and chromatographic data. Our quality protocols are designed to support GMP/GLP-compliant environments and meet the exacting standards required for pharmacopeial reference materials.

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. The container should be stored in a well-ventilated area away from incompatible materials.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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