Description

Ritonavir Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Ritonavir by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development and quality control.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ritonavir API and its formulations.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against regulatory specifications.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Stability Studies: Used to track the formation of degradation products in Ritonavir under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates studies on the chemical behavior, degradation pathways, and synthesis of Ritonavir and related compounds.

Basic Information

Product Name	Ritonavir Impurity 7
CAS No.	220887-39-8
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Related Compound 7; Ritonavir EP Impurity G; Ritonavir USP Impurity; 5-Thiazolylmethyl [(1S,2S,4S)-4-[[(2S)-2-[[(2S,3S,5S)-2-[[(2,6-Dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenylpentyl]amino]-1-(phenylmethyl)-3-(propan-2-yl)butyl]carbamoyl]-2-hydroxy-1-(phenylmethyl)propyl]carbamate; Lopinavir Impurity; Norvir Impurity
EINECS	Contact for details

Quality Control

Our Ritonavir Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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