Description

Prednisolone Impurity A CAS NO 77017-17-5 is a specified impurity of the corticosteroid drug Prednisolone, used as a critical reference standard in pharmaceutical quality control. This compound is essential for ensuring the purity, safety, and efficacy of Prednisolone and related steroid-based medications through accurate analytical profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing. The availability of a well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements for drug substance and product release.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Prednisolone Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Release Testing: Critical for routine batch analysis of Prednisolone to ensure compliance with pharmacopeial monographs (e.g., USP, EP, JP) and internal specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry and process development to understand and control impurity formation during the manufacturing of Prednisolone.

Basic Information

Product Name	Prednisolone Impurity A
CAS No.	77017-17-5
Molecular Formula	C21H28O5
Molecular Weight	360.45 g/mol
Synonyms	Prednisolone Related Compound A; 11β,17α,21-Trihydroxy-3,20-dioxopregna-1,4-dien-18-al; 18-Oxoprednisolone; 18-Formylprednisolone; Prednisolone 18-Aldehyde; 1,4-Pregnadiene-3,20-dione, 11,17,21-trihydroxy-18-oxo-, (11β)-; Prednisolone Impurity 1; Prednisolone EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Prednisolone Impurity A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using validated chromatographic (HPLC/UPLC) and spectroscopic (NMR, IR, MS) methods to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B guidelines and major pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.