Description

Prednisone Impurity 15 is a specified impurity of the corticosteroid drug Prednisone, identified by the CAS number 90039-93-3. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry focused on ensuring product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the qualitative and quantitative analysis of Prednisone and related steroid products.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control and Assurance: Critical for monitoring and controlling the level of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products to meet ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Prednisone.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research and Development: Used in synthetic chemistry R&D to study the formation and mitigation of process-related impurities.

Basic Information

Product Name	Prednisone Impurity 15
CAS No.	90039-93-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prednisone Related Compound 15; 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione; Impurity of Prednisone; Prednisone EP Impurity C; Prednisone Process Impurity; Steroid Impurity; (8S,9S,10R,13S,14S,17R)-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-3H-cyclopenta[a]phenanthrene-3,6,11-trione
EINECS	Contact for details

Quality Control

Every batch of Prednisone Impurity 15 (CAS 90039-93-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP/EP) and ICH guidelines for impurity standards. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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