Description

13-Ethyl-3-Ethynyl-18,19-Dinor-17α-Pregna-3,5-Dien-20-Yn-17-Ol is a high-purity pharmaceutical reference standard and impurity used in the development and quality control of active pharmaceutical ingredients (APIs). This compound is specifically identified as Levo Norgestrel Impurity, making it critical for ensuring the safety and efficacy of hormonal contraceptive and therapeutic products. It is essential for pharmaceutical manufacturers and analytical laboratories focused on method validation, stability studies, and regulatory compliance for steroid-based drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the qualitative and quantitative analysis of Levo Norgestrel and related steroid APIs.
• Impurity Profiling: Critical for identifying, monitoring, and controlling specified and unspecified impurities in drug substances and finished products as per ICH guidelines.
• Method Development & Validation (HPLC/GC): Serves as a key component in developing and validating chromatographic methods for purity and assay testing.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (light, heat, humidity) for drug substance stability testing.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Research & Development: Used in synthetic chemistry R&D for route scouting, process optimization, and impurity synthesis for steroid-based pharmaceuticals.
• Quality Control Laboratories: Essential for in-process control (IPC) and release testing to ensure batch-to-batch consistency and product safety.

Basic Information

Product Name	13-Ethyl-3-Ethynyl-18,19-Dinor-17α-Pregna-3,5-Dien-20-Yn-17-Ol (Levo Norgestrel Impurity)
CAS No.	1337972-89-0
Molecular Formula	C24H30O
Molecular Weight	334.50 g/mol
Synonyms	Levonorgestrel Related Compound; 17α-Ethynyl-13β-ethyl-17β-hydroxy-18,19-dinorgona-4,9-dien-3-one; 13β-Ethyl-17α-ethynyl-17β-hydroxy-18,19-dinor-4,9-gonadien-3-one; Levo-Norgestrel Impurity; Levonorgestrel EP Impurity; Levonorgestrel USP Impurity; Steroid Impurity Standard; 17-Hydroxy-13-ethyl-3-ethynyl-18,19-dinor-17α-pregna-3,5-dien-20-yne
EINECS	Contact for details

Quality Control

Every batch of 13-Ethyl-3-Ethynyl-18,19-Dinor-17α-Pregna-3,5-Dien-20-Yn-17-Ol is manufactured and analyzed under strict quality systems. Our products undergo rigorous testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines for impurities. Comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), is performed. A detailed Certificate of Analysis (COA) with batch-specific data is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C to 25°C (59°F to 77°F). Keep the container in a cool, dry, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to prevent potential degradation.

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 single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5% w/w

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