Description

Levonorgestrel Ep Impurity I CAS NO 20402-62-4 is a specified impurity of the active pharmaceutical ingredient Levonorgestrel, a key component in hormonal contraceptives and hormone replacement therapies. This compound is critical for pharmaceutical manufacturers to ensure the purity, safety, and regulatory compliance of their final drug products. It is primarily used by analytical laboratories and quality control departments in the pharmaceutical industry for method development, validation, and as a certified reference standard.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Levonorgestrel Ep Impurity I in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor and control impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure that Levonorgestrel API and related formulations meet stringent pharmacopeial (USP, EP, BP) purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Levonorgestrel-based products.
• Regulatory Submissions: Serves as a critical component in regulatory filings (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize the formation of this impurity.

Basic Information

Product Name	Levonorgestrel Ep Impurity I
CAS No.	20402-62-4
Molecular Formula	C21H28O2
Molecular Weight	312.45 g/mol
Synonyms	13-Ethyl-17-hydroxy-18,19-dinor-17α-pregna-4,15-dien-20-yn-3-one; 15,16-Didehydro-17α-ethynyl-17β-hydroxy-18-methyl-19-norandrost-4-en-3-one; Levonorgestrel 15,16-Didehydro Impurity; Levonorgestrel δ-15 Impurity; Levonorgestrel Related Compound I; 17α-Ethynyl-17β-hydroxy-18-methyl-19-norandrost-4,15-dien-3-one; Norlevonorgestrel
EINECS	Contact for details

Quality Control

Our Levonorgestrel Ep Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with current Good Manufacturing Practice (cGMP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry environment to prevent moisture uptake.

Specification

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

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