Description

Altrenogest Impurity 1 CAS NO 141299-96-9 is a specified impurity of the synthetic progestin Altrenogest, used in veterinary medicine. This reference standard is critical for analytical method development and validation, ensuring the purity and safety of the active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for research and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Altrenogest Impurity 1 in drug substance and finished product analysis.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance: Employed in routine QC testing to ensure Altrenogest batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling and control.
• Research & Development: Supports synthetic route optimization and process chemistry research to minimize impurity formation.

Basic Information

Product Name	Altrenogest Impurity 1
CAS No.	141299-96-9
Molecular Formula	C21H26O2
Molecular Weight	310.44 g/mol
Synonyms	Altrenogest Related Compound A; 17α-Allyl-17β-hydroxyestra-4,9,11-trien-3-one Impurity; (17α)-17-Hydroxy-17-(2-propen-1-yl)estra-4,9,11-trien-3-one Impurity 1; Altrenogest EP Impurity A; Altrenogest USP Impurity 1; Altrenogest Process Impurity; 17α-Allylestra-4,9,11-triene-3,17β-diol Related Substance
EINECS	Contact for details

Quality Control

Every batch of Altrenogest Impurity 1 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical impurity supply. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification tests performed using validated methods (HPLC, IR, etc.).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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