Description

Nicergoline Ep Impurity G is a specified impurity and degradation product of the pharmaceutical compound Nicergoline. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research and development (R&D) laboratories, quality assurance (QA) units, and contract research organizations (CROs) involved in the production and analysis of Nicergoline-based drug substances and products to ensure safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Nicergoline Ep Impurity G in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling of Nicergoline.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Nicergoline.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing procedures aligned with standards from the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other pharmacopoeias.

Basic Information

Product Name	Nicergoline Ep Impurity G
CAS No.	57935-65-6
Molecular Formula	C₂₄H₂₆BrN₃O₃
Molecular Weight	484.39 g/mol
Synonyms	10α-Methoxy-1,6-dimethylergoline-8β-methanol 5-bromo-3-pyridinecarboxylate (ester); 1-Methyl-10α-methoxy-9,10-dihydrolysergol 8β-(5-bromonicotinate); 5-Bromonicotinic acid (1-methyl-10α-methoxy-9,10-dihydrolysergol-8β-yl) ester; Nicergoline Impurity G; Nicergoline Related Compound G; 8β-[(5-Bromo-3-pyridinyl)carbonyl]oxy]-1,6-dimethyl-10α-methoxyergoline; 5-Bromo-3-pyridinecarboxylic acid (1-methyl-10α-methoxy-9,10-dihydrolysergol-8β-yl) ester
EINECS	Contact for details

Quality Control

Every batch of Nicergoline Ep Impurity G is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and consistency. Our products are suitable for use as reference standards in regulated environments. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.