Description

Ritonavir Ep Impurity O is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antiretroviral drug Ritonavir. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organization (CRO) sectors for method validation and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Ritonavir Ep Impurity O in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS/MS methods in compliance with ICH Q2(R1) and pharmacopeial requirements.
• Quality Control and Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels throughout the drug product's shelf life, ensuring compliance with ICH Q3A/B thresholds.
• Regulatory Submissions and Compliance: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity control strategies as per ICH guidelines.
• Pharmacopeial Testing: Used as a reference standard for testing against European Pharmacopoeia (EP) and other international pharmacopeia monographs for Ritonavir.
• Research and Development: Supports synthetic route optimization and process chemistry research to understand and minimize the formation of this specific impurity.

Basic Information

Product Name	Ritonavir Ep Impurity O
CAS No.	1414933-81-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ritonavir Related Compound O; Ritonavir Impurity O; Ritonavir EP Impurity O; (2S,3S,5S)-5-Amino-N-((2S,3S)-3-hydroxy-4-((4-methoxyphenyl)sulfonamido)-1-phenylbutan-2-yl)-2-((1S,2R)-1-hydroxy-2,3-dihydro-1H-inden-2-yl)-3-((tert-butoxycarbonyl)amino)pentanamide; UNII-7Q0K7QZ3S0; 7Q0K7QZ3S0; Ritonavir Sulfonamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Ritonavir Ep Impurity O is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, assay, and identification, is provided with each shipment to support your regulatory and quality assurance 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). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

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)	≥ 95.0%
Assay	≥ 97.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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