Description

n-Acetyl Norgestimate-D6 is a deuterated internal standard of the synthetic progestin norgestimate, specifically designed for analytical quantification. This high-purity compound is essential for ensuring accuracy and reliability in sensitive mass spectrometry-based assays. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control facilities for pharmacokinetic studies, bioequivalence testing, and impurity profiling of steroid-based pharmaceuticals.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of norgestimate and its metabolites in complex biological matrices like plasma and urine.
• Pharmaceutical R&D: Used in method development and validation for drug metabolism and pharmacokinetics (DMPK) studies of progestin-containing drugs.
• Bioanalytical Testing: Ensures data integrity in bioequivalence and clinical trial sample analysis for regulatory submissions.
• Metabolite Identification: Aids in the structural elucidation and tracking of deuterated metabolites in in vitro and in vivo studies.
• Quality Control & Impurity Profiling: Serves as a reference standard for assessing the purity and stability of norgestimate API and finished dosage forms.

Basic Information

Product Name	n-Acetyl Norgestimate-D6
CAS No.	1263195-02-3
Molecular Formula	C₂₃H₂₅D₆NO₅
Molecular Weight	407.55 g/mol
Synonyms	17α-Acetoxy-13-ethyl-18,19,20,21,21,21-hexadeuterio-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one 3-oxime; Deuterated N-Acetyl Norgestimate; Norgestimate-d6 Acetate; (17α)-17-(Acetyloxy)-13-ethyl-18,19,20,21,21,21-hexadeuterio-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one 3-oxime; n-Acetyl Norgestimate Hexadeuterated; Norgestimate Internal Standard-d6
EINECS	Contact for details

Quality Control

Our n-Acetyl Norgestimate-D6 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, assay, isotopic enrichment, and impurity profiles. We adhere to relevant industry standards for reference materials to guarantee reliable and reproducible performance in your critical assays.

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 stability, storing at -20°C is recommended.

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 (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines

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