Description

Prednisolone Impurity 11 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 regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific impurity in Prednisolone drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to ensure product purity meets pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization as per ICH Q3A and Q3B guidelines.
• Research and Development: Utilized in synthetic chemistry and metabolic studies to understand the formation pathways and biological relevance of this impurity.

Basic Information

Product Name	Prednisolone Impurity 11
CAS No.	115097-56-8
Molecular Formula	C21H28O5
Molecular Weight	360.45 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; 9α-Fluoroprednisolone; 9-Fluoroprednisolone; 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; Prednisolone 9α-Fluoro Derivative; 16β-Methyl-9α-fluoroprednisolone; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Prednisolone Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. This material is light-sensitive and should be handled accordingly to maintain stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay (on dried basis)	97.0% - 103.0%

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