Description

16-Dehydro Pregnenolone Acetate Impurity 2 is a high-purity reference standard and synthetic intermediate of significant importance in the pharmaceutical development process. This compound is critical for quality control and analytical method validation, ensuring the purity and safety of steroid-based active pharmaceutical ingredients (APIs). It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in the synthesis and quality assurance of steroidal drugs and hormones.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, GC, and LC-MS analysis in method development and validation.
• Quality Control & Assurance: Essential for identifying and quantifying related substances in bulk drug substances and finished dosage forms of steroidal APIs.
• Process Chemistry Research: Serves as a key intermediate or by-product marker in the synthesis and optimization of pregnenolone acetate derivatives.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Academic & Contract Research: Utilized in biochemical and pharmacological research studying steroidogenesis and hormone pathways.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 2
CAS No.	66905-18-8
Molecular Formula	C23H32O3
Molecular Weight	356.50 g/mol
Synonyms	16-Dehydropregnenolone Acetate; (3β)-3-(Acetyloxy)-16-pregnene-20-one; 16-Dehydro-3β-hydroxypregn-5-en-20-one acetate; Pregna-5,16-dien-3β-ol-20-one acetate; 3β-Acetoxypregna-5,16-dien-20-one; 16-Dehydro-3β-acetoxypregn-5-en-20-one; Pregnenolone Acetate 16-Dehydro Impurity
EINECS	Contact for details

Quality Control

Every batch of 16-Dehydro Pregnenolone Acetate Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with industry standards for reference materials. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material 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 unknown 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.