Description

Rocuronium Bromide Intermediate B Impurity E-1 is a critical pharmaceutical reference standard and impurity used in the 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 active pharmaceutical ingredient (API) by serving as a key marker for process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Rocuronium Bromide.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of process-related impurities in Rocuronium Bromide API.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of Intermediate B Impurity E-1, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Stability Studies: Used to track the formation or degradation of this specific impurity under various storage conditions over time.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this impurity during the manufacturing of Rocuronium Bromide.

Basic Information

Product Name	Rocuronium Bromide Intermediate B Impurity E-1
CAS No.	1190105-60-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rocuronium Bromide Impurity E-1; Rocuronium Bromide Related Compound E-1; Rocuronium Impurity E-1; (1R,2R,4S,5S,13S,16S,19S)-13-(2-Morpholinoethyl)-16-(prop-2-en-1-yl)-2-(piperidin-1-yl)-19-(quinolin-8-yloxy)-8,11-dioxa-4-azapentacyclo[10.7.1.0²,⁵.0⁵,¹⁹.0¹⁴,¹⁸]icosa-14(18),15-dien-20-one (bromide salt); Rocuronium Bromide Intermediate B Impurity; 1-[(2β,3α,5α,16β,17β)-17-(Acetyloxy)-3-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methylpiperidinium Bromide Impurity E-1.
EINECS	Contact for details

Quality Control

Our Rocuronium Bromide Intermediate B Impurity E-1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines.

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 and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
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.