Description

Deltacortinene Acetate (Prednisolone Acetate Impurity) is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the accurate identification, quantification, and control of impurities in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by analytical laboratories, quality control departments, and R&D teams within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of process-related impurities in Prednisolone Acetate API.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and GC analytical methods.
• Quality Control & Assurance: Essential for routine batch testing in QC labs to monitor impurity levels against ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed as a marker to track degradation pathways and assess the shelf-life of pharmaceutical formulations containing corticosteroids.
• Research on Steroid Metabolism & Synthesis: Used in academic and industrial research to study steroid chemistry, synthesis pathways, and metabolic by-products.

Basic Information

Product Name	Deltacortinene Acetate (Prednisolone Acetate Impurity)
CAS No.	4380-55-6
Molecular Formula	C23H28O6
Molecular Weight	400.47 g/mol
Synonyms	Prednisolone Acetate Impurity; 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate; 1,4-Pregnadiene-11β,17α,21-triol-3,20-dione 21-acetate; Deltacortinene Acetate; Prednisolone 21-Acetate Related Compound; (11β)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate
EINECS	Contact for details

Quality Control

Every batch of Deltacortinene Acetate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white 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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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