Description

Pancuronium Bromide Related Compound A is a high-purity chemical reference standard, essential for pharmaceutical research and quality control. This compound is critical for ensuring the accuracy and reliability of analytical methods used to assess the purity and stability of the neuromuscular blocking agent, Pancuronium Bromide. It serves as a vital tool for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, enabling precise identification and quantification of related substances.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Pancuronium Bromide active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing, validating, and verifying High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity testing.
• Stability Studies: Used to monitor the formation of degradation products in Pancuronium Bromide under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control (QC) Testing: Employed in routine batch release testing within pharmaceutical QC laboratories to ensure product safety and compliance with pharmacopoeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development: Supports metabolic and pharmacokinetic studies by helping to identify and characterize related substances in biological matrices.

Basic Information

Item	Details
Product Name	Pancuronium Bromide Related Compound A
CAS No.	15500-65-9
Molecular Formula	C23H38Br2N2O4
Molecular Weight	566.37 g/mol
Synonyms	3α,17β-Bis(acetyloxy)-2β,16β-dipiperidino-5α-androstane dibromide; 2β,16β-Dipiperidino-5α-androstane-3α,17β-diol diacetate dibromide; Pancuronium Bromide Impurity A; Pancuronium Dibromide Related Compound A; 5α-Androstane-3α,17β-diol, 2β,16β-dipiperidino-, diacetate, dibromide; Pancuronium Bromide EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Pancuronium Bromide Related Compound A is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with stringent reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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