Description

Rocuronium Bromide Impurity 14 is a designated impurity of the neuromuscular blocking agent Rocuronium Bromide, a critical pharmaceutical intermediate. This compound is essential for analytical method development, stability studies, and ensuring the purity and safety of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and research and development purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rocuronium Bromide API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Rocuronium Bromide.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in pharmaceutical quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research on Synthesis Pathways: Used in chemical research to study and optimize the synthesis process of Rocuronium Bromide, helping to minimize impurity formation.

Basic Information

Item	Details
Product Name	Rocuronium Bromide Impurity 14
CAS No.	930092-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rocuronium Bromide Related Compound 14; Rocuronium Impurity 14; 930092-99-2; 1-(2β,3α,5α,16β,17β)-17-(Acetyloxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl]-1-(2-propenyl)pyrrolidinium Bromide Impurity; Rocuronium Bromide EP Impurity C; Potential degradation product of Rocuronium
EINECS	Contact for details

Quality Control

Our Rocuronium Bromide Impurity 14 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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