Description

Ritonavir Ep Impurity B is a specified impurity and degradation product of the antiretroviral drug Ritonavir. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method validation and quality control. It is essential for laboratories and manufacturers in the pharmaceutical industry who require high-purity materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of Ritonavir impurities.
• Analytical method development and validation (HPLC, LC-MS) for Ritonavir drug substance and finished product testing.
• Quality control and stability studies to monitor impurity profiles in active pharmaceutical ingredients (APIs).
• Pharmacopoeial testing to ensure compliance with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH guidelines.
• Research into the degradation pathways and stability of Ritonavir formulations.
• Calibration of analytical equipment for precise impurity measurement in pharmaceutical analysis.

Basic Information

Product Name	Ritonavir Ep Impurity B
CAS No.	765875-58-9
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Impurity B; Ritonavir Related Compound B; (5S,8S,10S,11S)-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-0C8Z31N21I; Ritonavir EP Impurity B; Ritonavir USP Impurity B; Ritonavir Degradant B
EINECS	Contact for details

Quality Control

Every batch of Ritonavir Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and mass spectrometry, to ensure identity, purity, and compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory documentation.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown 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.