Description

Dexamethasone Impurity 19 is a specified impurity and degradation product of the potent synthetic glucocorticoid, Dexamethasone. This compound is of critical importance in the pharmaceutical industry for analytical method development, quality control, and regulatory compliance. It is primarily used by research institutions, quality assurance laboratories, and pharmaceutical manufacturers involved in the synthesis and purification of Dexamethasone API to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Dexamethasone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Dexamethasone batches meet stringent pharmacopeial standards (USP, EP, JP) for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by chemists to study and optimize the Dexamethasone synthesis pathway, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Dexamethasone Impurity 19
CAS No.	39005-10-2
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-Acetate; Dexamethasone EP Impurity J; Dexamethasone Related Compound J; 21-Acetoxy-9-fluoro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione; Dexamethasone 21-Acetate Impurity; (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-acetate
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial and in-house specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and ISO 17034 guidelines for reference material production.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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