Description

(11β,16β)-11,21-Bis(Acetyloxy)-2'-Methyl-5'H-Pregna-1,4-Dieno[17,16-D]Oxazole-3,20-Dione (Deflazacort Impurity) 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 active pharmaceutical ingredient (API) Deflazacort by serving as a known impurity for method development and validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance and quality control in steroid-based drug production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Deflazacort API and finished dosage forms.
• Analytical Method Development: Critical for developing, validating, and calibrating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing data for impurity identification and control strategies as per ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Deflazacort to understand degradation pathways and product shelf-life.
• Research & Development: Serves as a key intermediate or marker in the synthetic pathway research and process chemistry optimization for corticosteroid APIs.
• Quality Assurance/Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure API purity meets pharmacopeial specifications.

Basic Information

Product Name	(11β,16β)-11,21-Bis(Acetyloxy)-2'-Methyl-5'H-Pregna-1,4-Dieno[17,16-D]Oxazole-3,20-Dione (Deflazacort Impurity)
CAS No.	710951-92-1
Molecular Formula	C25H31NO7
Molecular Weight	457.52 g/mol
Synonyms	Deflazacort Impurity; Deflazacort Related Compound; 11β,21-Diacetoxy-2'-methyl-5'βH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione; (11β,16β)-11,21-Diacetoxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione; Pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, 11,21-bis(acetyloxy)-2'-methyl-, (11β,16β)-; Steroid Impurity
EINECS	Contact for details

Quality Control

Our (11β,16β)-11,21-Bis(Acetyloxy)-2'-Methyl-5'H-Pregna-1,4-Dieno[17,16-D]Oxazole-3,20-Dione (Deflazacort Impurity) is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 at 2-8°C. Keep the container tightly sealed to protect from moisture.

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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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