Description

Nomegestrol Acetate Impurity A is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient, Nomegestrol Acetate. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic and spectroscopic analyses. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies involved in the development and production of hormone-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Nomegestrol Acetate API batches.
• Method Development & Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC, to meet ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure API compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Nomegestrol Acetate formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and impurity profiling during the drug development process.

Basic Information

Product Name	Nomegestrol Acetate Impurity A
CAS No.	32420-14-7
Molecular Formula	C23H30O4
Molecular Weight	370.48 g/mol
Synonyms	17α-Acetoxy-6-methyl-19-norpregna-4,6-diene-3,20-dione; 6-Methyl-17α-acetoxy-19-nor-4,6-pregnadiene-3,20-dione; 17α-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione acetate; Nomegestrol Impurity A; NOM Imp A; 17α-Acetoxy-6-methyl-19-nor-4,6-pregnadiene-3,20-dione; 6-Methyl-19-norpregna-4,6-diene-3,20-dione, 17-(acetyloxy)-, (17α)-
EINECS	Contact for details

Quality Control

Our Nomegestrol Acetate Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (HPLC, IR), assay (by HPLC), and related substance analysis. We support compliance with current Good Manufacturing Practices (cGMP) and relevant pharmacopeial standards for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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