Description

Ritonavir Ep Impurity I CAS NO 165315-26-4 is a specified impurity associated with the antiretroviral active pharmaceutical ingredient (API) Ritonavir. This compound is critical for pharmaceutical research, development, and quality control, serving as a key reference standard for analytical method validation and impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ritonavir-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ritonavir API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity levels.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure Ritonavir batches comply with stringent pharmacopeial specifications (e.g., EP, USP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to establish product shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to health authorities like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Ritonavir.

Basic Information

Product Name	Ritonavir Ep Impurity I
CAS No.	165315-26-4
Molecular Formula	C37H48N6O5S2
Molecular Weight	720.94 g/mol
Synonyms	Ritonavir Impurity I; Ritonavir Related Compound I; Ritonavir EP Impurity I; (5S,8S,10S,11S)-10-Hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic Acid, 5-Thiazolylmethyl Ester; L-735,524 Impurity I; Norvir Impurity I
EINECS	Contact for details

Quality Control

Our Ritonavir Ep Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept tightly sealed after each use to prevent moisture absorption.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified 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.