Description

Norgestimate Related Compound A (25 Mg) (Levonorgestrel Acetate) is a high-purity reference standard and pharmaceutical intermediate. This compound is critical for analytical method development, validation, and quality control processes in the manufacture of steroid-based active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract manufacturing organizations (CMOs) engaged in the production and testing of hormonal contraceptives and other steroidal therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Norgestimate and Levonorgestrel drug substances and finished products via HPLC, UPLC, or GC analysis.
• Impurity Profiling: Essential for method development and validation studies to monitor and control specified and unspecified impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Development & Validation: Serves as a key intermediate or marker in the synthesis and scale-up of steroidal APIs, aiding in route scouting and process optimization.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity standards for qualification and toxicological assessment.
• Quality Control Testing: Employed in in-house QC laboratories for routine batch release testing of raw materials and finished pharmaceutical products to ensure compliance with pharmacopeial monographs (USP, EP, BP).
• Academic & Clinical Research: Utilized in university and institutional research studying the metabolism, stability, and analytical chemistry of synthetic progestins.

Basic Information

Product Name	Norgestimate Related Compound A (25 Mg) (Levonorgestrel Acetate)
CAS No.	13732-69-9
Molecular Formula	C24H31NO4
Molecular Weight	397.51 g/mol
Synonyms	Levonorgestrel 3-(O-Acetyloxime); 13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one 3-(O-acetyloxime); 17α-(Acetyloxy)-13-ethyl-18,19-dinor-17α-pregn-4-en-20-yn-3-one oxime; Norgestrel 3-(O-Acetyloxime); Related Compound A of Norgestimate; 3-(Acetyloxy)imino-13-ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one
EINECS	Contact for details

Quality Control

Our Norgestimate Related Compound A is manufactured and tested under strict quality management systems. Each batch is characterized using advanced analytical techniques including HPLC, GC, NMR, and Mass Spectrometry to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against stringent in-house specifications. The material is suitable for use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline 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	≤ 1.0%

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