Description

Ritonavir Impurity 8 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Ritonavir during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance testing for antiviral medications.

Application

• Pharmaceutical Impurity Profiling and Identification in Ritonavir API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) for accurate quantification of impurities.
• Quality Control and Batch Release Testing to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies to monitor impurity levels in drug substances and products over time.
• Regulatory Submissions as a characterized reference standard for FDA, EMA, and other global health authority filings.
• Research and Development of Ritonavir and related protease inhibitor compounds.

Basic Information

Product Name	Ritonavir Impurity 8
CAS No.	220887-40-1
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Related Compound 8; Ritonavir EP Impurity B; Ritonavir USP Impurity; 5-Thiazolylmethyl [(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]carbamate; Lopinavir/Ritonavir Impurity; Norvir Impurity
EINECS	Contact for details

Quality Control

Every batch of Ritonavir Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.