Description

Ritonavir Ep Impurity T is a high-purity 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) Ritonavir. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Ritonavir Ep Impurity T in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Ritonavir API.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in pharmaceutical QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Ritonavir formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in R&D to study the degradation pathways and metabolism of Ritonavir.

Basic Information

Product Name	Ritonavir Ep Impurity T
CAS No.	869368-48-9
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Related Compound T; Ritonavir Impurity T; Ritonavir EP Impurity T; 869368-48-9; (5S,8S,10R,11S,12S)-10-Hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic Acid 5-Thiazolylmethyl Ester; UNII-9S4JQN7Q7G; 9S4JQN7Q7G
EINECS	Contact for details

Quality Control

Our Ritonavir Ep Impurity T is manufactured under strict quality control protocols to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized and tested using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your regulatory and quality 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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