Description

Cabergoline Impurity B is a designated pharmaceutical impurity used as a critical reference standard in analytical chemistry. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Cabergoline through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cabergoline API and finished drug products.
• Analytical Method Development: Critical for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Cabergoline formulations.
• Research & Development: Serves as a key intermediate or marker in the research of Cabergoline synthesis pathways and degradation mechanisms.

Basic Information

Item	Details
Product Name	Cabergoline Impurity B
CAS No.	166533-36-4
Molecular Formula	C26H37N5O2
Molecular Weight	451.61 g/mol
Synonyms	6-Allyl-8β-[(methylthio)methyl]-1-[(3-(dimethylamino)propyl]-ergoline-2,15-dione; Cabergoline Related Compound B; Cabergoline EP Impurity B; Cabergoline USP Impurity B; (8β)-6-Allyl-1-[(3-(dimethylamino)propyl]-8-[(methylthio)methyl]ergoline-2,15-dione
EINECS	Contact for details

Quality Control

Every batch of Cabergoline Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to meet the high-purity standards required for use as a pharmaceutical reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (typically ≥95% by HPLC), and impurity profile. Our quality protocols are designed to support compliance with ICH guidelines and relevant pharmacopeial requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated exposure to air.

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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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