Description

Levonorgestrel Impurity 10 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of levonorgestrel-based pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Levonorgestrel Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation in Quality Control (QC) and Research & Development (R&D) laboratories.
• Stability Studies to monitor impurity profiles and degradation pathways of levonorgestrel formulations over time.
• Regulatory Compliance and Documentation, supporting submissions to agencies like the FDA, EMA, and other global health authorities.
• Pharmacopoeial Testing, aiding in compliance with standards set by USP, EP, and other pharmacopoeias.
• Academic and Clinical Research into the metabolism, pharmacokinetics, and synthesis of progestin compounds.

Basic Information

Product Name	Levonorgestrel Impurity 10
CAS No.	2911-81-1
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-Dehydrolevonorgestrel; δ15-Levonorgestrel; Levonorgestrel Related Compound C; 17α-Ethynyl-18-methyl-19-nor-4,15-androstadien-17β-ol-3-one; Norplant Impurity; D(-)-Norgestrel Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Levonorgestrel Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, GC, NMR, and MS. Certificates of Analysis (COA) with detailed chromatographic data are available upon request.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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