Description

16-Dehydro Pregnenolone Acetate Impurity 12 is a high-purity reference standard used in the analytical characterization of steroid-based pharmaceutical compounds. This impurity is critical for ensuring the quality, safety, and regulatory compliance of active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling for steroid synthesis and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in 16-Dehydro Pregnenolone Acetate and related steroid APIs.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Serves as a critical benchmark in QC laboratories to confirm the purity of bulk drug substances and ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of pharmaceutical stability testing.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings with agencies such as the FDA, EMA, and PMDA to support drug approval processes.
• Research & Development: Used in synthetic chemistry R&D to understand reaction pathways, optimize synthesis, and control impurity formation during steroid manufacturing.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 12
CAS No.	911452-26-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pregna-5,16-dien-20-one, 3-(acetyloxy)-; 3β-Acetoxypregna-5,16-dien-20-one; 16-Dehydropregnenolone acetate impurity; Steroid impurity 12; Pregnenolone acetate derivative; 16-Dehydro Pregnenolone Acetate Related Compound; (3β)-3-(Acetyloxy)pregna-5,16-dien-20-one
EINECS	Contact for details

Quality Control

Every batch of 16-Dehydro Pregnenolone Acetate Impurity 12 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the stringent standards required for pharmaceutical reference materials. Our quality system is designed to guarantee identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS is provided with each shipment to support your regulatory and quality assurance needs.

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 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
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%

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