Description

Dienogest Impurity I is a specified impurity and degradation product of the active pharmaceutical ingredient Dienogest. It is a critical reference standard used in the pharmaceutical industry to ensure the purity, safety, and efficacy of Dienogest-based drug products. This compound is essential for analytical method development, validation, and routine quality control testing. Pharmaceutical manufacturers and analytical laboratories require this high-purity standard to meet stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dienogest Impurity I in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation and analysis.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Dienogest API, supporting compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation.

Basic Information

Product Name	Dienogest Impurity I
CAS No.	65928-65-6
Molecular Formula	C20H25NO2
Molecular Weight	311.42 g/mol
Synonyms	17-Hydroxy-3-oxo-19-nor-17α-pregna-4,9-diene-21-nitrile; 17α-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile; Dienogest Related Compound I; Dienogest EP Impurity I; Dienogest USP Impurity I; Dienogest Process Impurity; 19-Nor-17α-pregna-4,9-diene-3-one, 17-hydroxy-21-cyano-
EINECS	Contact for details

Quality Control

Every batch of Dienogest Impurity I is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS, IR) to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with in-house specifications aligned with ICH guidelines. Custom synthesis and purification to meet specific pharmacopeial standards (USP, EP) are available.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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