Description

Ritonavir o-Acyl Isomer CAS NO 959315-21-0 is a specific stereoisomer of the Ritonavir molecule, a key intermediate in the synthesis of the active pharmaceutical ingredient (API). This compound is critical for pharmaceutical research and development, particularly in the study of antiviral drug metabolism, impurity profiling, and analytical method development. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development and quality control of antiviral therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the o-acyl isomer impurity in Ritonavir API and finished drug products.
• Process Chemistry Research: Used in route scouting and optimization studies to understand and control isomer formation during the synthesis of Ritonavir.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor isomer-related impurities.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized material for impurity qualification and specification setting.
• Metabolism and Pharmacokinetic Studies: Employed in preclinical and clinical studies to investigate the biological activity and metabolic pathways of different Ritonavir isomers.
• Quality Control Laboratories: Used as a system suitability test component and for routine batch release testing in QC labs to ensure API purity.

Basic Information

Product Name	Ritonavir o-Acyl Isomer
CAS No.	959315-21-0
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Isomer; Ritonavir Related Compound; o-Acyl Ritonavir; 5-Thiazolylmethyl [(1S,2S,4S)-4-[[(2S)-2-[[(2S,3S,5S)-3-Hydroxy-5-[[(2S)-3-Methyl-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-diphenylhexan-2-yl]carbamoyl]-4-methylpentanoyl]amino]-2-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]carbamate; Lopinavir/Ritonavir Isomer; Norvir Isomer
EINECS	Contact for details

Quality Control

Our Ritonavir o-Acyl Isomer is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with cGMP guidelines for pharmaceutical intermediates. Specifications are aligned with ICH Q3A/B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive (store away from light). For long-term storage, consider storage under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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