Description

Prednisone 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 prednisone and related corticosteroid pharmaceuticals. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of impurities in prednisone active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Used as a standard to develop and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance: Essential for routine quality control testing in GMP environments to monitor batch-to-batch consistency and ensure product purity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies of prednisone to understand impurity formation pathways.
• Research & Development: Used in academic and industrial R&D for studying the metabolism, synthesis pathways, and degradation chemistry of corticosteroids.

Basic Information

Product Name	Prednisone Impurity 13
CAS No.	91160-89-3
Molecular Formula	C21H26O5
Molecular Weight	358.43 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; Prednisone Related Compound; Prednisone Impurity F (Potential); Fluocortisone Impurity
EINECS	Contact for details

Quality Control

Every batch of Prednisone Impurity 13 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity data is provided with each shipment.

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.