Description

16-Dehydro Pregnenolone Acetate Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products derived from steroid intermediates. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in steroid synthesis, method development, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of process-related impurities in steroid-based Active Pharmaceutical Ingredients (APIs).
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods (e.g., HPLC, UPLC) for quality control laboratories.
• Stability Studies: Employed as a marker compound to monitor the degradation pathways and stability of pregnenolone acetate derivatives under various storage conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Chemical Research & Synthesis: Acts as a key intermediate or reference point in the research and development of novel steroid analogs and synthetic pathways.
• Quality Control & Batch Release: Used in-house by manufacturers to establish specification limits and ensure batch-to-batch consistency of final drug products.

Basic Information

Product Name	16-Dehydro Pregnenolone Acetate Impurity 8
CAS No.	19324-55-1
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-Pregnenolone Acetate Impurity 8; Pregnenolone Acetate Related Compound A (in specific contexts)
EINECS	Contact for details

Quality Control

Every batch of 16-Dehydro Pregnenolone Acetate Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing all test 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). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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