Description

Prednisone Impurity 24 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of prednisone and related corticosteroid pharmaceuticals. It is primarily utilized by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in prednisone active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports academic and industrial research into the metabolism, degradation pathways, and synthesis of corticosteroid compounds.

Basic Information

Product Name	Prednisone Impurity 24
CAS No.	1058-04-4
Molecular Formula	C21H26O5
Molecular Weight	358.43 g/mol
Synonyms	Prednisone Related Compound 24; 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione; 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione; Prednisone Degradant; Prednisone Process Impurity; (11β)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Prednisone Impurity 24 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling. Comprehensive Certificates of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, GC-MS, NMR) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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