Description

Flunisolide Related Compound A is a high-purity chemical reference standard critical for analytical and quality control processes in the pharmaceutical industry. This compound serves as a key impurity marker and system suitability standard for ensuring the purity, safety, and efficacy of the corticosteroid drug Flunisolide. It is essential for research and development laboratories, quality assurance units, and regulatory bodies that require precise analytical standards for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Flunisolide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards such as USP, EP, and ICH guidelines.
• Stability Studies: Acts as a reference point in forced degradation and long-term stability studies to track the formation of related substances over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to study degradation pathways and to synthesize and characterize Flunisolide derivatives.

Basic Information

Product Name	Flunisolide Related Compound A
CAS No.	75575-02-9
Molecular Formula	C24H31FO6
Molecular Weight	434.50 g/mol
Synonyms	6α,9α-Difluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone; 6α,9α-Difluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,17-acetonide; Flunisolide Impurity A; Flunisolide EP Impurity A; Flunisolide Related Substance A; 6α,9α-Difluoroprednisolone 16,17-acetonide
EINECS	Contact for details

Quality Control

Our Flunisolide Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided, confirming compliance with relevant pharmacopeial guidelines. Our quality commitment supports your regulatory and research needs with reliable and traceable 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term stability, consider storage under an inert atmosphere.

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

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