Description

Triamcinolone Impurity 4 is a specified impurity and degradation product of the corticosteroid Triamcinolone. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Triamcinolone-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Triamcinolone drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: A critical component in the QC testing of Triamcinolone to comply with pharmacopeial standards (USP, EP, BP).
• Stability Studies: Used to track and quantify degradation products formed during forced degradation and long-term stability studies of pharmaceutical formulations.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and impurity profiling during the drug development process.

Basic Information

Product Name	Triamcinolone Impurity 4
CAS No.	3800-28-0
Molecular Formula	C21H27FO6
Molecular Weight	394.44 g/mol
Synonyms	9α-Fluoro-11β,16α,17α,21-tetrahydroxypregna-1,4-diene-3,20-dione; 9α-Fluoro-11β,16α,17α,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,17-Acetonide Impurity; Triamcinolone Related Compound D; 16α,17α-Isopropylidenedioxy-9α-fluoro-11β,21-dihydroxypregna-1,4-diene-3,20-dione; Triamcinolone Acetonide Impurity D
EINECS	Contact for details

Quality Control

Every batch of Triamcinolone Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing HPLC purity, related substances, and spectroscopic data are provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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