Description

Cobicistat Impurity 2 Trihcl is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antiretroviral drug Cobicistat. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities during drug substance manufacturing to ensure final product safety and efficacy. It is an essential material for analytical method development, stability studies, and regulatory compliance documentation within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Cobicistat drug substance and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of active pharmaceutical ingredients (APIs) to ensure batches meet stringent purity specifications per ICH guidelines.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of Cobicistat formulations.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research to optimize manufacturing processes and reduce impurity formation.

Basic Information

Product Name	Cobicistat Impurity 2 Trihcl
CAS No.	1051463-15-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cobicistat Related Compound 2; Cobicistat Impurity B; Cobicistat Process Impurity; 1,3-Thiazol-5-ylmethyl N-[(2R,5R)-5-{[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)carbamoyl]-1,3-thiazolidin-2-yl]carbamate trihydrochloride; GS-9350 Impurity 2; Tybost Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Cobicistat Impurity 2 Trihcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment to support your quality and regulatory requirements.

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 (moisture-sensitive) nature, the container must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
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.