Description

Ivosidenib is a targeted small molecule inhibitor designed for precision therapeutic applications. This compound matters as a critical active pharmaceutical ingredient (API) for the development and manufacturing of advanced oncology treatments. It is primarily needed by pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in innovative cancer therapy production.

Application

• Primary Active Pharmaceutical Ingredient (API) in the formulation of targeted cancer therapeutics.
• Key intermediate in advanced pharmaceutical research and development for hematologic malignancies.
• Reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Biochemical research tool for studying isocitrate dehydrogenase 1 (IDH1) mutations and related metabolic pathways.
• Use in preclinical and clinical studies for evaluating the efficacy of IDH1 inhibition.
• Manufacturing of finished dosage forms under current Good Manufacturing Practice (cGMP) conditions.

Basic Information

Product Name	Ivosidenib
CAS No.	1448347-49-6
Molecular Formula	C₂₈H₂₂ClF₃N₆O₃
Molecular Weight	582.96 g/mol
Synonyms	AG-120; Tibsovo (Brand Name); (S)-N-(1-(2-Chloro-6-fluorophenyl)ethyl)-1-(2,6-difluorophenyl)-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidine-3-carboxamide; (S)-N-((1-(2-Chloro-6-fluorophenyl)ethyl)-1-(2,6-difluorophenyl)-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidine-3-carboxamide; IDH1 Inhibitor AG-120; IDH1 Inhibitor IVO; AG120; CS-1376
EINECS	Contact for details

Quality Control

Our Ivosidenib is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols align with ICH guidelines, and the product is supported by comprehensive analytical data. A Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each batch to ensure traceability and compliance for regulatory submissions.

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 container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

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