Description

Ritonavir Impurity CAS NO 1283151-18-7 is a high-purity chemical 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. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in antiviral drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Ritonavir API and its formulated drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to ensure Ritonavir meets pharmacopeial (USP, EP) and internal purity specifications.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development (R&D): Facilitates studies on the degradation pathways, synthesis, and toxicological assessment of Ritonavir-related substances.

Basic Information

Product Name	Ritonavir Impurity
CAS No.	1283151-18-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ritonavir Related Compound; Ritonavir Degradant; Ritonavir Process Impurity; Ritonavir Specified Impurity; (2S,3S,5S)-2-(2,6-Dimethylphenoxy)acetyl]amino]-3-hydroxy-5-[2S)-3-methyl-2-{[methyl({[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl})carbamoyl]amino}butanamido]-1,6-diphenylhexan-4-yl (2-methylpropyl)carbamate (Potential IUPAC); Lopinavir/Ritonavir Impurity; Norvir Impurity; CAS 1283151-18-7
EINECS	Contact for details

Quality Control

Every batch of Ritonavir Impurity (CAS 1283151-18-7) is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing results from tests such as HPLC purity, related substances, and spectroscopic identification, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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