Description

Rocuronium Bromide Impurity 15 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the neuromuscular blocking agent, Rocuronium Bromide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety and efficacy. The use of this well-defined impurity standard is essential for method validation, stability studies, and meeting stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Rocuronium Bromide active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS), for impurity detection and quantification.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels, ensuring compliance with ICH Q3A and Q3B guidelines.
• Stability Studies: A key component in forced degradation and long-term stability studies to identify and track impurity formation in Rocuronium Bromide formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to establish impurity thresholds, specifications, and the overall safety profile of the drug substance.
• Research and Development: Used in synthetic chemistry R&D to understand degradation pathways and to optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Rocuronium Bromide Impurity 15
CAS No.	1145787-10-5
Molecular Formula	C32H53BrN2O4
Molecular Weight	609.69 g/mol
Synonyms	Rocuronium Bromide Related Compound 15; Rocuronium Impurity 15; (1R,2R,4S,5S,7S,10S,11S,13S,14S,16S,18S)-18-(3-Hydroxy-2-propanyl)-16-(2-((4-morpholinyl)acetyl)oxy)-1,2,4,5,7,10,11,13,14,15,16,17-dodecahydro-14-methyl-7,10-methano-1H-cyclopenta[a]phenanthren-2-yl 1-piperidinecarboxylate bromide; Rocuronium Bromide EP Impurity C; Rocuronium Bromide USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Rocuronium Bromide Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
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.