Description

Triamcinolone Impurity 1 is a specified impurity and degradation product of the synthetic glucocorticoid 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 drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Triamcinolone Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Triamcinolone formulations under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and meeting the requirements of pharmacopoeias like USP, EP, and BP.
• Process Chemistry & Impurity Profiling: Used in research to understand and control impurity formation during the synthesis, purification, and scale-up of Triamcinolone API manufacturing.
• Quality Assurance/Quality Control (QA/QC): A critical component for routine batch release testing to ensure impurity levels are within specified safety limits.

Basic Information

Product Name	Triamcinolone Impurity 1
CAS No.	2367-73-9
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-tetrahydroxy-1,4-pregnadiene-3,20-dione; Triamcinolone Related Compound A; 1,4-Pregnadiene-9α-fluoro-11β,16α,17α,21-tetrol-3,20-dione; Fluoxyprednisolone; Triamcinolone EP Impurity A; Triamcinolone USP Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Triamcinolone Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.