Description

Levonorgestrel Impurity 16 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Levonorgestrel. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, quality control, and compliance of hormonal contraceptives and other therapeutic agents.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Levonorgestrel API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, and GC analytical methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs), ANDAs, and INDs.
• Stability Studies: Used to monitor impurity profiles in Levonorgestrel formulations under various stress and long-term storage conditions.
• Process Chemistry & R&D: Aids in the optimization of synthetic pathways and purification processes by tracking specific impurity formation.
• Pharmacopoeial Testing: Employed in testing to meet the stringent purity requirements of pharmacopoeias such as USP, EP, and BP.

Basic Information

Product Name	Levonorgestrel Impurity 16
CAS No.	14507-47-2
Molecular Formula	C21H28O2
Molecular Weight	312.45 g/mol
Synonyms	13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one; 17α-Ethynyl-17β-hydroxy-18-methyl-19-norandrost-4-en-3-one related compound; Levonorgestrel Related Compound; 18-Methyl-19-norethisterone; Norlevonorgestrel; (17α)-13-Ethyl-17-hydroxy-18,19-dinorpregn-4-en-20-yn-3-one
EINECS	Contact for details

Quality Control

Every batch of Levonorgestrel Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry and pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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