Description

Norethindrone-D6 CAS NO 2376036-05-2 is a high-purity, stable isotope-labeled analog of the synthetic progestin Norethindrone, where six hydrogen atoms are replaced by deuterium. This compound is an essential internal standard for the precise and accurate quantification of Norethindrone in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development, pharmacokinetic studies, and drug metabolism research.

Application

• Bioanalytical Method Development: Serves as a critical internal standard for developing and validating sensitive and specific LC-MS/MS methods for Norethindrone quantification.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration in plasma, serum, and other biological fluids to study absorption, distribution, metabolism, and excretion.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Norethindrone.
• Clinical Trial Support: Provides reliable data for bioequivalence and bioavailability studies required for regulatory submissions.
• Forensic and Anti-Doping Analysis: Facilitates the precise detection and confirmation of Norethindrone in forensic toxicology and sports doping control.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and assay validation of Norethindrone active pharmaceutical ingredients (APIs) and finished dosage forms.

Basic Information

Product Name	Norethindrone-D6
CAS No.	2376036-05-2
Molecular Formula	C₂₀H₂₀D₆O₂
Molecular Weight	304.45 g/mol
Synonyms	19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-, hexadeuterated; 17α-Ethynyl-19-nortestosterone-D6; 17α-Ethynylestr-4-en-17β-ol-3-one-D6; Norethisterone-D6; Norlutin-D6; Norethindrone hexadeuterated; Deuterated Norethindrone; Norethindrone (hexadeutero)
EINECS	Contact for details

Quality Control

Our Norethindrone-D6 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment, chemical purity, and residual solvent content. We adhere to cGMP principles where applicable to support our clients' regulatory needs in pharmaceutical development and analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 99.0%
Residual Solvents (GC)	Complies with ICH guidelines

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