Description

Prednisolone Impurity 7 is a specified impurity used in the quality control and analytical profiling of the corticosteroid drug, Prednisolone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference standard for method development, validation, and routine testing in compliance with stringent pharmacopeial guidelines. Professionals in pharmaceutical R&D, quality assurance, and contract research organizations rely on this high-purity impurity for accurate chromatographic analysis.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Prednisolone API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) to meet ICH Q3A/B guidelines.
• Essential for stability studies and forced degradation studies to understand the degradation pathways of Prednisolone.
• Used in quality control laboratories for routine batch release testing and impurity profiling.
• Supports regulatory submissions by providing necessary impurity data for FDA, EMA, and other global health authority filings.
• Valuable for academic and institutional research focusing on steroid chemistry, metabolism, and impurity synthesis.

Basic Information

Product Name	Prednisolone Impurity 7
CAS No.	61549-70-0
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-δ1-hydrocortisone; 9α-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; Prednisolone 9α-Fluoro Analog; 16β-Methyl-9α-fluoroprednisolone
EINECS	Contact for details

Quality Control

Every batch of Prednisolone Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and high-purity requirements typical for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH, USP, and EP guidelines.

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 light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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