Description

16-Dehydro Pregnenolone Acetate Impurity 9 is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. This compound is critical for the accurate identification, quantification, and monitoring of related substances in the synthesis of steroidal active pharmaceutical ingredients (APIs). It is primarily needed by research institutions, analytical laboratories, and manufacturers engaged in the development and production of steroidal drugs, ensuring regulatory compliance and product safety.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the calibration of analytical instruments and validation of methods in HPLC, GC, and LC-MS systems.
• Impurity Profiling: Essential for the identification and quantification of process-related impurities and degradation products in Pregnenolone Acetate and related steroid APIs.
• Method Development & Validation: Serves as a critical component in developing and validating stability-indicating assay methods for regulatory filings (e.g., ICH guidelines).
• Chemical Synthesis Intermediate: Acts as a key building block or precursor in the multi-step synthesis of complex steroidal molecules for research purposes.
• Quality Assurance/Quality Control (QA/QC): Employed in in-house quality control laboratories to ensure batch-to-batch consistency and purity of final drug substances.
• Academic & Biomedical Research: Used in studies investigating steroid biochemistry, metabolic pathways, and the structure-activity relationships of steroid hormones.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 9
CAS No.	66880-01-1
Molecular Formula	C23H32O3
Molecular Weight	356.50 g/mol
Synonyms	16-Dehydropregnenolone acetate; (3β)-3-(Acetyloxy)-16-pregnene-20-one; Pregna-5,16-dien-20-one, 3-(acetyloxy)-, (3β)-; 3β-Acetoxypregna-5,16-dien-20-one; 16-Dehydro-3β-acetoxypregn-5-en-20-one; Pregnenolone Acetate 16-Dehydro Impurity; 16-DPA Impurity 9
EINECS	Contact for details

Quality Control

Every batch of 16-Dehydro Pregnenolone Acetate Impurity 9 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, IR, MS) techniques to ensure compliance with industry standards for reference materials. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white crystalline 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%
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.