Description

16-Dehydro Pregnenolone Acetate Impurity 5 is a high-purity reference standard and synthetic intermediate of significant importance in the pharmaceutical industry. This compound is critical for analytical method development, validation, and quality control processes, ensuring the purity and safety of steroid-based active pharmaceutical ingredients (APIs). It is primarily utilized by research institutions, analytical laboratories, and manufacturers engaged in the development and production of steroidal drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Pregnenolone Acetate and its derivative APIs using HPLC, GC, or LC-MS methods.
• Analytical Method Development: Essential for developing and validating stability-indicating assay methods to monitor degradation products in pharmaceutical formulations.
• Process Chemistry Research: Used as a key intermediate or model compound in synthetic pathways for novel steroidal molecules in medicinal chemistry.
• Quality Assurance & Control (QA/QC): Employed in routine batch release testing to ensure final drug products meet stringent pharmacopeial purity specifications (e.g., ICH Q3A/B guidelines).
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity profiles and characterization data for drug master files (DMFs).

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 5
CAS No.	6795-58-0
Molecular Formula	C23H32O3
Molecular Weight	356.50 g/mol
Synonyms	16-Dehydropregnenolone Acetate; (3β)-3-(Acetyloxy)-16-pregnene-20-one; 3β-Hydroxypregna-5,16-dien-20-one 3-acetate; Pregna-5,16-dien-3β-ol-20-one acetate; 16-Dehydro-δ5-pregnenolone acetate; Pregnenolone Acetate Impurity 5; 5,16-Pregnadien-3β-ol-20-one 3-acetate
EINECS	Contact for details

Quality Control

Our 16-Dehydro Pregnenolone Acetate Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of specific impurities, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain optimal stability.

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.