Description

Nomegestrol Impurity 1 is a designated impurity of the active pharmaceutical ingredient Nomegestrol, a synthetic progestin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Nomegestrol acetate API and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and analyze Nomegestrol and its related substances.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the API in compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to track the formation of degradation products in Nomegestrol formulations under various stress conditions.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Nomegestrol acetate.

Basic Information

Product Name	Nomegestrol Impurity 1
CAS No.	147508-44-9
Molecular Formula	C₂₃H₃₀O₄
Molecular Weight	370.48 g/mol
Synonyms	Nomegestrol Related Compound A; 17α-Acetoxy-6-methyl-19-norpregna-4,6-diene-3,20-dione Impurity; 6-Methyl-17α-acetoxy-19-nor-4,6-pregnadiene-3,20-dione Impurity; 17α-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione 17-acetate Impurity; Nomegestrol Acetate Impurity A; Lutenyl Impurity; (17α)-17-(Acetyloxy)-6-methyl-19-norpregna-4,6-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our Nomegestrol Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, NMR, and MS. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A, Q3B, and Q6A 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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