Description

Fluocortolone Pivalate Ep Impurity C is a high-purity reference standard specifically identified as a process-related impurity of Fluocortolone Pivalate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by research institutions, quality control laboratories, and API producers involved in the synthesis and purification of corticosteroid active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in pharmaceutical quality control.
• Method Development and Validation: Essential for developing and validating analytical methods to quantify and control Fluocortolone Pivalate impurity levels.
• Regulatory Compliance and Filing: Used to support regulatory submissions (e.g., to FDA, EMA) by characterizing and controlling impurities as per ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles of Fluocortolone Pivalate drug substances and products.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Fluocortolone Pivalate to minimize impurity formation.
• Quality Assurance (QA) Testing: Used as a system suitability and identification standard in routine batch release testing of APIs.

Basic Information

Product Name	Fluocortolone Pivalate Ep Impurity C
CAS No.	79884-56-3
Molecular Formula	C27H37FO6
Molecular Weight	476.58 g/mol
Synonyms	6α-Fluoro-11β,21-dihydroxy-16α-methyl-3,20-dioxopregna-1,4-diene-17-yl pivalate; 6α-Fluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-pivalate; Fluocortolone 17-pivalate impurity C; Fluocortolone Pivalate Related Compound C; Fluocortolone Pivalate EP Impurity C; Fluocortolone Pivalate Impurity C; 6α-Fluoro-16α-methylprednisolone 17-pivalate
EINECS	Contact for details

Quality Control

Our Fluocortolone Pivalate Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) with batch-specific data 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. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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