Description

Bromocriptine Impurity E is a designated impurity standard used in the analytical profiling of the active pharmaceutical ingredient Bromocriptine. This high-purity reference material is critical for pharmaceutical manufacturers and quality control laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Bromocriptine Impurity E in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Bromocriptine API meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve manufacturing processes.

Basic Information

Item	Detail
Product Name	Bromocriptine Impurity E
CAS No.	2492-53-7
Molecular Formula	C₃₂H₄₀BrN₅O₅
Molecular Weight	654.59 g/mol
Synonyms	2-Bromo-α-ergocryptine; 2-Bromoergocryptine; 2-Bromolysergide; Bromocriptine Impurity E (EP); Bromocriptine Related Compound E; 2-Bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)ergotaman-3',6',18-trione; (5'α)-2-Bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)ergotaman-3',6',18-trione
EINECS	Contact for details

Quality Control

Our Bromocriptine Impurity E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment ensures the material is suitable for its intended use as a high-grade reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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