Description

Rocuronium Bromide Impurity 30 is a specified impurity of the neuromuscular blocking agent, Rocuronium Bromide. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Rocuronium Bromide drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rocuronium Bromide active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine quality control testing to establish acceptance criteria and ensure batch-to-batch consistency of Rocuronium Bromide.
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability studies of Rocuronium Bromide formulations.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Rocuronium Bromide to minimize the formation of this specific impurity.

Basic Information

Product Name	Rocuronium Bromide Impurity 30
CAS No.	56240-11-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rocuronium Bromide Related Compound 30; Rocuronium Impurity 30; 1-[17β-(Acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium Bromide Impurity; 16β-[1-(2-Propenyl)pyrrolidinium-1-yl]-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-17β-yl Acetate Bromide Impurity; (2β,3α,5α,16β,17β)-16-(1-Allylpyrrolidinium-1-yl)-3-hydroxy-2-(morpholin-4-yl)androstan-17-yl Acetate Bromide Impurity
EINECS	Contact for details

Quality Control

Our Rocuronium Bromide Impurity 30 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, MS, NMR). We provide comprehensive Certificates of Analysis (COA) that detail the batch-specific results, ensuring traceability and compliance with pharmaceutical industry standards. The material is suitable for use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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