Description

16-Dehydro Pregnenolone Acetate Impurity 11 is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. This specific impurity is critical for ensuring the safety and efficacy of steroid-based active pharmaceutical ingredients (APIs) by enabling accurate analytical method development and validation. It is primarily required by research institutions, analytical laboratories, and manufacturers engaged in the synthesis, purification, and regulatory compliance of steroid compounds.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, quantification, and qualification of impurities in 16-Dehydro Pregnenolone Acetate and related steroid APIs.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor process-related impurities and ensure product purity.
• Process Chemistry Research: Serves as a key intermediate or marker in studying and optimizing synthetic pathways for steroid hormones.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing to comply with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines) for impurity profiling.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to global health authorities.
• Academic & Contract Research: Utilized in university and CRO settings for metabolic studies, stability testing, and degradation pathway analysis of steroid molecules.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 11
CAS No.	68520-34-3
Molecular Formula	C23H32O3
Molecular Weight	356.50 g/mol
Synonyms	16-Dehydropregnenolone Acetate Impurity 11; Pregna-5,16-dien-3β-ol-20-one, 3-acetate; 3β-Acetoxypregna-5,16-dien-20-one; 16-Dehydro-3β-hydroxypregn-5-en-20-one acetate; (3β)-3-(Acetyloxy)pregna-5,16-dien-20-one; 16-Dehydro Pregnenolone Acetate Related Compound; Pregnenolone Acetate Impurity 11
EINECS	Contact for details

Quality Control

Our 16-Dehydro Pregnenolone Acetate Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and all test results is provided with every shipment.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.