Description

Prednisone Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the corticosteroid drug Prednisone by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on compliance and product development.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Prednisone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Prednisone.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Prednisone formulations.
• Research & Synthesis: Serves as a starting material or intermediate for synthetic chemists working on the synthesis or structural modification of corticosteroid analogs.

Basic Information

Item	Detail
Product Name	Prednisone Impurity 9
CAS No.	97830-94-9
Molecular Formula	C21H26O5
Molecular Weight	358.43 g/mol
Synonyms	9-Dehydro-17,21-dihydroxypregna-1,4-diene-3,11,20-trione; 9(11)-Dehydroprednisone; Prednisone 9(11)-Dehydro Impurity; 1,4-Pregnadiene-9(11),17α,21-triol-3,20-dione; 9,11-Dehydroprednisone; Prednisone Related Compound; 9,11-Dehydrocortisone; 9(11)-Dehydro-17α,21-dihydroxypregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Prednisone Impurity 9 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, MS, and NMR. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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% w/w
Residue on Ignition	≤ 0.1%

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