Description

6β-Hydroxy Norgestrel is a key pharmaceutical intermediate and reference standard, specifically a hydroxylated derivative of the progestin norgestrel. This compound is critical for analytical research, method development, and quality control processes in the synthesis of steroid-based active pharmaceutical ingredients (APIs). It is primarily utilized by research institutions, pharmaceutical manufacturers, and quality control laboratories involved in the development and production of hormonal contraceptives and other steroidal medications.

Application

• Pharmaceutical Reference Standard: Used for the identification, assay, and impurity profiling of norgestrel and related progestin APIs in compliance with pharmacopeial methods (e.g., USP, EP).
• Analytical Research: Serves as a critical metabolite or degradation product marker in stability studies and bioanalytical method development for hormonal drugs.
• Process Chemistry: Acts as an intermediate or a chemical marker in the synthesis and scale-up of advanced steroid molecules.
• Quality Control (QC) & Quality Assurance (QA): Essential for calibrating equipment and validating analytical methods like HPLC and GC to ensure batch-to-batch consistency and purity of final drug products.
• Academic & Institutional Research: Employed in pharmacological and metabolic studies to understand the structure-activity relationships of synthetic progestins.

Basic Information

Product Name	6β-Hydroxy Norgestrel
CAS No.	55555-97-0
Molecular Formula	C₂₁H₂₈O₂
Molecular Weight	312.45 g/mol
Synonyms	6β-Hydroxynorgestrel; 13β-Ethyl-17β-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one 6β-ol; 6β-Hydroxy-13β-ethyl-17β-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one; 6β-OH Norgestrel; Norgestrel 6β-ol; Levonorgestrel 6β-hydroxy derivative; 6β-Hydroxy-13β-ethyl-17α-ethynyl-17β-hydroxygon-4-en-3-one
EINECS	Contact for details

Quality Control

Our 6β-Hydroxy Norgestrel 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 high-purity standards suitable for pharmaceutical research and development. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your regulatory and quality documentation needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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