Description

Dienogest-D8 is a deuterated analog of the progestin Dienogest, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity compound is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, where it corrects for variations in sample preparation and instrument response. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in method development, pharmacokinetic studies, and quality control for hormone-based therapeutics.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of Dienogest and its metabolites in biological matrices (plasma, serum, urine) during bioanalytical studies.
• Pharmaceutical Research & Development: Used in method development and validation for drug substance and drug product analysis in support of regulatory filings (e.g., IND, NDA).
• Pharmacokinetic and Bioequivalence Studies: Enables accurate measurement of drug concentration over time, which is fundamental for assessing absorption, distribution, metabolism, and excretion (ADME) profiles.
• Clinical Trial Support: Provides reliable data for monitoring drug levels in patients during clinical phases of drug development.
• Reference Material for Metabolite Identification: Aids in the structural elucidation and quantification of deuterated metabolites in complex samples.
• Quality Control & Stability Testing: Serves as a benchmark in analytical procedures to ensure the consistency and purity of pharmaceutical formulations containing progestins.

Basic Information

Product Name	Dienogest-D8
CAS No.	2376035-92-4
Molecular Formula	C20H17D8NO2
Molecular Weight	319.48 g/mol
Synonyms	17α-Hydroxy-3-oxo-19-nor-17α-pregna-4,9-diene-21-nitrile-D8; (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile-D8; Dienogest-d8; Deuterated Dienogest; Dienogest Internal Standard; 19-Nor-17α-pregna-4,9-diene-17α-ol-3-one-21-nitrile-D8
EINECS	Contact for details

Quality Control

Every batch of Dienogest-D8 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request and include detailed results for identity, purity (by HPLC), isotopic enrichment, and residual solvents, supporting applications in GLP and GMP settings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at -20°C under an inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
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.