Description

Norethindrone β-D-Glucuronide CAS NO 64701-11-7 is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical research and development. This compound is a key metabolite of the progestin norethindrone, making it an essential analytical standard for pharmacokinetic and bioequivalence studies. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism, clinical diagnostics, and regulatory compliance testing. Our supply ensures consistent quality and reliable availability for critical development workflows.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative analysis of norethindrone and its metabolites in biological matrices via LC-MS/MS or HPLC.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used as an analytical calibrant to study the absorption, distribution, metabolism, and excretion (ADME) profile of norethindrone.
• Clinical Diagnostic Assay Development: Essential for developing and validating immunoassays or chromatographic methods to monitor hormone levels in clinical samples.
• Impurity Profiling and Characterization: Acts as a known impurity or degradation product reference in the quality control of active pharmaceutical ingredients (APIs) and finished drug products.
• Synthetic Intermediate: Utilized in the chemical synthesis of more complex steroid conjugates or labeled analogs for advanced research.
• Regulatory Compliance and Bioequivalence Testing: Critical for meeting FDA, EMA, and other global health authority requirements for generic drug approval and post-market surveillance.

Basic Information

Product Name	Norethindrone β-D-Glucuronide
CAS No.	64701-11-7
Molecular Formula	C₂₅H₃₄O₉
Molecular Weight	478.53 g/mol
Synonyms	19-Norpregn-4-en-20-yn-3-one, 17-(β-D-Glucopyranuronosyloxy)-17-hydroxy-, (17α)-; Norethisterone β-D-Glucuronide; 17α-Ethynyl-17β-hydroxy-4-estren-3-one β-D-Glucuronide; Norethindrone Glucuronide; Noriday β-D-Glucuronide; Norethisterone Glucuronide; 17α-Ethynyl-19-nortestosterone β-D-Glucuronide
EINECS	Contact for details

Quality Control

Every batch of Norethindrone β-D-Glucuronide is manufactured and tested under strict quality management systems. We provide material suitable for use as an analytical reference standard, with comprehensive testing to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting results for key parameters including assay, related substances, and residual solvents. Our quality commitment aligns with the standards expected for pharmaceutical research and development.

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 compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white 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)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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