Description

Dexamethasone Impurity 9 is a high-purity reference standard of a specified impurity associated with the synthetic pathway of the corticosteroid Dexamethasone. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and quality assurance laboratories in the pharmaceutical and biotechnology sectors, supporting compliance with stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dexamethasone Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control impurity levels throughout the drug manufacturing process, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used to identify and track degradation products in forced degradation and long-term stability studies of Dexamethasone formulations.
• Research & Development: Facilitates research into the synthesis, metabolism, and toxicological profile of Dexamethasone and its related substances.

Basic Information

Product Name	Dexamethasone Impurity 9
CAS No.	84449-15-0
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9,11β-Epoxy-16α-methyl-3,20-dioxopregna-1,4-diene-17,21-diol; 9,11β-Epoxy-16α-methylpregna-1,4-diene-3,20-dione-17,21-diol; Dexamethasone EP Impurity G; Dexamethasone Related Compound G; Dexamethasone 9,11β-Epoxide; (11β,16α)-9,11-Epoxy-17,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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