Description

Fluorometholone Impurity CAS NO 2796-99-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Fluorometholone, a potent corticosteroid. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of this well-characterized impurity standard is essential for maintaining the highest standards in pharmaceutical quality control and drug development.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and stability testing of Fluorometholone API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control and Release Testing: Employed in routine QC laboratories to confirm that Fluorometholone batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to assess the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf life.
• Research and Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies related to corticosteroid pharmaceuticals.

Basic Information

Item	Detail
Product Name	Fluorometholone Impurity
CAS No.	2796-99-8
Molecular Formula	C22H29FO4
Molecular Weight	376.46 g/mol
Synonyms	9α-Fluoro-11β,17α-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione; 6α-Methyl-9α-fluoro-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione related compound; Fluorometholone Related Compound A; Fluorometholone EP Impurity; Fluorometholone USP Impurity; 6α-Methyl-9α-fluoroprednisolone; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Fluorometholone Impurity CAS 2796-99-8 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and confirmatory identification (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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