Description

Methylergometrinine Impurity is a high-purity reference standard critical for analytical research and pharmaceutical quality control. This compound is essential for the accurate identification, quantification, and monitoring of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine testing in HPLC, UPLC, and GC analyses.
• Quality Control & Assurance: Used for quantifying and controlling the level of Methylergometrinine-related impurities in bulk APIs and final drug formulations to meet pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of pharmaceutical products containing related compounds.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and characterization data.
• Research & Development: Utilized in synthetic chemistry R&D for process optimization and impurity fate and tolerance studies.
• Metabolite Studies: Can be used as a starting point or reference in pharmacological and toxicological research investigating metabolic pathways.

Basic Information

Product Name	Methylergometrinine Impurity
CAS No.	5516-91-6
Molecular Formula	C₂₀H₂₅N₃O₂
Molecular Weight	339.44 g/mol
Synonyms	Methylergometrinine; 9,10-Didehydro-N-[1-(hydroxymethyl)propyl]-6-methylergoline-8β-carboxamide; Lysergol, 8β-carboxy-N-(1-hydroxymethylpropyl)-6-methyl-, (8β)-; Methylergometrinine Impurity A; Methylergonovine Impurity; Methergine Impurity; CAS 5516-91-6
EINECS	Contact for details

Quality Control

Every batch of our Methylergometrinine Impurity is manufactured and tested under strict quality management systems. The product undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against stringent in-house specifications. Our quality commitment supports compliance with cGMP and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). Keep the container in a dry, cool, and well-ventilated area.

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)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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