Description

Ep Levonorgestrel Impurity D is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing levonorgestrel by serving as a key marker for impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Primary use as a certified reference standard for the identification and quantification of related substances in Levonorgestrel Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, GC) in pharmaceutical quality control laboratories.
• Used in stability studies to monitor the formation of degradation products in levonorgestrel-based formulations over time.
• Serves as a critical component in regulatory submissions (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Applied in research and development to understand the synthesis pathways and degradation behavior of levonorgestrel.
• Utilized for calibrating laboratory equipment to ensure accurate and reproducible analytical results.

Basic Information

Item	Detail
Product Name	Ep Levonorgestrel Impurity D
CAS No.	32419-58-2
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 impurity; Levonorgestrel EP Impurity D; Levonorgestrel Related Compound D; 18-Methyl-19-nor-17α-pregn-4-en-20-yn-3-one, 17β-ol; Norlevonorgestrel; (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
EINECS	Contact for details

Quality Control

Every batch of Ep Levonorgestrel Impurity D is manufactured and tested under a strict quality management system. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (e.g., EP, USP) and customer-specific requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles. We are committed to supplying reference materials that meet the exacting needs of pharmaceutical analysis and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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