Description

16-Dehydro Pregnenolone Acetate Impurity 1 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and production of steroidal drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Pregnenolone Acetate and related steroid APIs.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Serves as a critical component in routine batch release testing to ensure compliance with pharmacopeial limits for impurities (e.g., ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive characterization data for impurity profiles.
• Stability Studies: Employed to track the formation of degradation products in steroidal drug substances and products under various storage conditions.
• Research & Development: Used in synthetic chemistry research to study reaction pathways and optimize purification processes for steroid synthesis.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 1
CAS No.	15346-23-3
Molecular Formula	C23H32O3
Molecular Weight	356.50 g/mol
Synonyms	16-Dehydropregnenolone Acetate; 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; Pregnenolone Acetate Impurity 1; 16-Dehydro Pregnenolone Acetate; (3β)-3-(Acetyloxy)pregna-5,16-dien-20-one
EINECS	Contact for details

Quality Control

Our 16-Dehydro Pregnenolone Acetate Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 stored away from direct light exposure.

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%
Loss on Drying	≤ 0.5%

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