Description

Ritonavir Impurity CAS NO 1414933-89-3 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 a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ritonavir API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure product specifications are met.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Used to monitor the formation of degradation products in Ritonavir formulations under various stress conditions.
• Research & Development (R&D): Supports synthetic chemistry research, including route scouting and process optimization for Ritonavir manufacturing.

Basic Information

Product Name	Ritonavir Impurity
CAS No.	1414933-89-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ritonavir Related Compound; Ritonavir Process Impurity; Ritonavir Degradant; Ritonavir Specified Impurity; (2S,3S,5S)-5-Amino-3-hydroxy-1,6-diphenyl-2-(1-piperidinyl)hexane Impurity; Norvir Impurity; CAS 1414933-89-3
EINECS	Contact for details

Quality Control

Every batch of Ritonavir Impurity CAS 1414933-89-3 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are suitable for use as reference standards in pharmaceutical analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

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) and must be kept in a desiccated environment to maintain stability. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Maximum Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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