Description

Rocuronium Bromide Impurity CAS NO 13492-57-4 is a critical reference standard used in the pharmaceutical development and quality control of the neuromuscular blocking agent, Rocuronium Bromide. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, production, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Rocuronium Bromide API and finished formulations.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic analyses for the identification, characterization, and quantification of process-related impurities and degradation products.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity profiles and control strategies as per ICH guidelines.
• Stability Studies: Employed to monitor impurity formation in Rocuronium Bromide under various stress conditions (e.g., heat, light, humidity) to establish shelf life and storage recommendations.
• Process Chemistry Optimization: Helps in identifying the source of impurities during API synthesis, enabling process refinement to minimize their formation and improve yield.

Basic Information

Product Name	Rocuronium Bromide Impurity
CAS No.	13492-57-4
Molecular Formula	C32H53BrN2O4
Molecular Weight	609.69 g/mol
Synonyms	1-[17β-(Acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium Bromide; 16β-(1-Allyl-2-pyrrolidinyl)-3α,17β-dihydroxy-2β-(4-morpholinyl)-5α-androstane 17-acetate Bromide; Rocuronium Bromide Related Compound; (2β,3α,5α,16β,17β)-17-(Acetyloxy)-2-(4-morpholinyl)-16-(1-propen-3-yl-2-pyrrolidinyl)androstane-3,17-diol Bromide; Rocuronium Impurity; Norcuron Impurity
EINECS	Contact for details

Quality Control

Every batch of Rocuronium Bromide Impurity CAS 13492-57-4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay 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 to support your quality and regulatory needs.

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. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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