Description

16-Dehydro Pregnenolone Acetate Impurity 3 is a specific chemical reference standard used in the analysis and quality control of steroid-based pharmaceutical products. This compound is critical for ensuring the purity and safety of active pharmaceutical ingredients (APIs) and finished drug formulations by serving as a known impurity marker. It is primarily required by analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology industries for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in batches of 16-Dehydro Pregnenolone Acetate and related steroid intermediates.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in QC labs.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and control strategies.
• Stability Studies: Employed as a benchmark to track the formation of degradation products in stability testing of steroid APIs under various storage conditions.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of steroid hormones.
• Quality Control Testing: A key component in the routine release testing of pharmaceutical raw materials and finished products to ensure they meet stringent purity specifications.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 3
CAS No.	1173-11-1
Molecular Formula	C23H32O3
Molecular Weight	356.50 g/mol
Synonyms	Pregna-5,16-dien-20-one, 3-(acetyloxy)-; 3β-Acetoxypregna-5,16-dien-20-one; 3β-Hydroxypregna-5,16-dien-20-one 3-acetate; 16-Dehydro-3β-hydroxypregn-5-en-20-one acetate; 16-Dehydropregnenolone acetate; Pregnenolone acetate 16-dehydro impurity; (3β)-3-(Acetyloxy)pregna-5,16-dien-20-one
EINECS	Contact for details

Quality Control

Every batch of 16-Dehydro Pregnenolone Acetate Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.