Description

16β-Hydroxy Norgestrel is a key pharmaceutical intermediate and reference standard in the synthesis of steroid-based active pharmaceutical ingredients (APIs). This compound is of critical importance for ensuring the purity, efficacy, and regulatory compliance of final drug products. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and quality control of hormonal contraceptives and other therapeutic agents.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of advanced steroid APIs, including progestins.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing via HPLC, GC, or LC-MS.
• Active Pharmaceutical Ingredient (API) Research: Serves as a precursor or derivative in the research and development of new hormonal therapies.
• Impurity Standard: Employed to identify, quantify, and control related substances and degradation products in norgestrel-based drug formulations.
• Biochemical Research: Used in studies investigating steroid metabolism, receptor binding, and hormonal pathways.

Basic Information

Item	Details
Product Name	16β-Hydroxy Norgestrel
CAS No.	40915-03-5
Molecular Formula	C₂₁H₂₈O₃
Molecular Weight	328.45 g/mol
Synonyms	13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one; 16β-Hydroxynorgestrel; 16β-Hydroxy-13-ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one; Levonorgestrel Impurity; Norgestrel Related Compound; 16β-OH Norgestrel; 16β-Hydroxy-13β-ethyl-17α-ethynyl-17β-hydroxygon-4-en-3-one
EINECS	Contact for details

Quality Control

Our 16β-Hydroxy Norgestrel is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling, to ensure it meets the stringent requirements for pharmaceutical intermediates and reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.