Description

Dexamethasone Impurity I is a specified impurity of the potent synthetic glucocorticoid, Dexamethasone. This compound is critical for pharmaceutical research, development, and quality control processes, where precise identification and quantification of impurities are mandated by regulatory authorities. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the safety, efficacy, and purity of Dexamethasone drug substances and products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Dexamethasone Impurity I in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Dexamethasone.

Basic Information

Product Name	Dexamethasone Impurity I
CAS No.	14622-47-0
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione; 16α-Methyl-9α-fluoroprednisolone; 9α-Fluoro-16α-methylprednisolone; Dexamethasone Related Compound I; Dexamethasone EP Impurity I; Dexamethasone USP Related Compound I; Prednisolone, 9-fluoro-16-methyl-
EINECS	Contact for details

Quality Control

Our Dexamethasone Impurity I is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity determination and spectroscopic methods for structural confirmation. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting compliance with ICH guidelines and pharmacopeial expectations. Specifications are designed to meet the stringent requirements of pharmaceutical research and regulatory applications.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.