Description

Prednisone Impurity D (Ep) is a specified impurity of the corticosteroid drug Prednisone, identified in pharmacopeial monographs. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Prednisone API and its formulations.

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 (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to separate and analyze Prednisone and its related substances.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure batches comply with stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Prednisone formulations under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Academic & Contract Research: Supports research in synthetic chemistry, impurity profiling, and degradation pathway studies within academic institutions and CROs (Contract Research Organizations).

Basic Information

Product Name	Prednisone Impurity D (Ep)
CAS No.	10184-69-7
Molecular Formula	C21H26O5
Molecular Weight	358.43 g/mol
Synonyms	Prednisone EP Impurity D; 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione; 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione; Prednisone Related Compound D; (11β)-17,21-Dihydroxypregna-1,4-diene-3,11,20-trione
EINECS	Contact for details

Quality Control

Our Prednisone Impurity D (Ep) is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances. A Certificate of Analysis (COA) is provided with each shipment, detailing the results against relevant pharmacopeial standards (USP, EP).

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) and should be handled in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.