Description

Prednisolone Impurity 13 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 pharmaceutical products containing prednisolone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling. The use of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining product integrity.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in prednisolone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for purity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP, BP).
• Stability Studies: Utilized as a marker in forced degradation and long-term stability studies to understand the degradation pathways of prednisolone under various environmental conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) by characterizing and controlling potential impurities, supporting New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Research and Development: Supports synthetic chemistry research, metabolic studies, and the development of new analytical techniques related to corticosteroid compounds.

Basic Information

Product Name	Prednisolone Impurity 13
CAS No.	905-52-2
Molecular Formula	C21H28O5
Molecular Weight	360.45 g/mol
Synonyms	11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione; 1,4-Pregnadiene-11β,17α,21-triol-3,20-dione; Prednisolone Related Compound; Prednisolone EP Impurity; Prednisolone USP Impurity; 1-Dehydrohydrocortisone; δ1-Hydrocortisone
EINECS	Contact for details

Quality Control

Our Prednisolone Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results for identity, purity, and impurities. Our quality commitment aligns with the needs of cGMP-compliant environments and supports compliance with ICH and major pharmacopeia guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a cool, dry, and well-ventilated area. Avoid exposure to excessive heat and moisture.

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% w/w

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