Description

Prednisolone Impurity 1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing Prednisolone. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for regulatory compliance and maintaining high production standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Prednisolone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection limits.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation and increase of this impurity over time in drug substance and product stability programs under various stress conditions.
• Regulatory Submissions and Compliance: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Utilized in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic byproducts of Prednisolone.

Basic Information

Product Name	Prednisolone Impurity 1
CAS No.	111186-92-6
Molecular Formula	C21H28O5
Molecular Weight	360.44 g/mol
Synonyms	Prednisolone EP Impurity B; Prednisolone Related Compound B; 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione Impurity; (8S,9S,10R,13S,14S,17R)-17-(2-Hydroxyacetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-3H-cyclopenta[a]phenanthrene-3,11,14-triol; Prednisolone Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Prednisolone Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques, including HPLC, GC, and NMR, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, test methods, and acceptance criteria.

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 must be kept in a desiccated environment to maintain stability and purity.

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 single unknown impurity ≤ 0.5%
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.