Description

17-Desacetyl Norgestimate-D6 (Mixture Of Isomers) is a deuterated analog of a key pharmaceutical intermediate, specifically designed for use as an internal standard in analytical chemistry. This compound is critical for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments involved in the development and testing of steroidal hormone-based therapeutics.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of norgestimate and its metabolites in complex biological matrices like plasma and serum.
• Pharmaceutical R&D: Supports method development and validation in the research of contraceptive and hormone replacement therapies.
• Bioanalytical Testing: Used in CROs for conducting GLP-compliant pharmacokinetic, toxicokinetic, and bioequivalence studies.
• Metabolite Studies: Aids in the identification and quantification of specific desacetylated metabolite pathways.
• Quality Control & Stability Testing: Ensures batch-to-batch consistency and monitors degradation products in finished drug products.
• Regulatory Submissions: Provides the validated data required for FDA, EMA, and other global regulatory agency filings.

Basic Information

Product Name	17-Desacetyl Norgestimate-D6 (Mixture Of Isomers)
CAS No.	1263184-13-9
Molecular Formula	C₂₁H₂₇D₆NO₄
Molecular Weight	~ 377.55 g/mol
Synonyms	13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one 3-(O)-oxime-d6; 17-Deacetyl Norgestimate-d6; (17α)-13-Ethyl-17-hydroxy-18,19-dinorpregn-4-en-20-yn-3-one 3-(O)-oxime-d6; Norgestimate Impurity D6; Norgestimate-d6 Desacetyl Metabolite; Deuterated Norgestimate Metabolite; 17-Desacetyl-NGM-d6
EINECS	Contact for details

Quality Control

Every batch of 17-Desacetyl Norgestimate-D6 (Mixture Of Isomers) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with the high-purity standards required for analytical applications. Certificates of Analysis (COA) detailing isotopic purity, chemical purity, and identity confirmation are provided with each shipment.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.