Description

Prednisone Impurity 26 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 the active pharmaceutical ingredient (API) Prednisone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The compound is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Prednisone API and its formulations.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Prednisone under various stress conditions as per ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways of Prednisone and related corticosteroids.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure API purity meets pharmacopeial standards (USP, EP).

Basic Information

Product Name	Prednisone Impurity 26
CAS No.	107085-25-6
Molecular Formula	C21H26O5
Molecular Weight	358.43 g/mol
Synonyms	Prednisone Related Compound 26; 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione; 11-Dehydrocortisone Impurity; 1,4-Pregnadiene-17α,21-diol-3,11,20-trione; Prednisone EP Impurity B (Check specific monograph); Prednisone Process Impurity; Cortisone Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Prednisone Impurity 26 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material should be handled under inert conditions if specified to prevent degradation.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5% w/w
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.