Description

Temsirolimus is a potent and selective mTOR (mammalian target of rapamycin) kinase inhibitor, representing a critical class of targeted therapeutic agents. Its primary value lies in its clinical application as an antineoplastic drug, specifically for the treatment of advanced renal cell carcinoma. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug development and production. The consistent quality and reliable supply of Temsirolimus CAS NO 162635-04-3 are paramount for ensuring the efficacy and safety of the final medicinal product.

Application

• Active Pharmaceutical Ingredient (API): Primary use as the key therapeutic component in formulated anti-cancer injectables.
• Oncology Research: A vital reference standard and tool compound for studying mTOR signaling pathways, tumor cell proliferation, and angiogenesis in preclinical models.
• Drug Development: Serves as a lead compound or benchmark for the synthesis and evaluation of novel rapamycin analogs and mTOR inhibitors.
• Bioscience Studies: Used in cellular and molecular biology research to investigate the role of mTOR in cell growth, metabolism, and autophagy.
• Pharmaceutical Analysis: Employed as a high-purity analytical standard for quality control (QC) and quality assurance (QA) testing in API and finished product manufacturing.
• Formulation Development: Critical for developing stable parenteral dosage forms, requiring compatibility studies with various excipients.

Basic Information

Item	Details
Product Name	Temsirolimus
CAS No.	162635-04-3
Molecular Formula	C56H87NO16
Molecular Weight	1030.29 g/mol
Synonyms	CCI-779; Torisel™ (Trade Name); 42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]rapamycin; Rapamycin 42-[2,2-bis(hydroxymethyl)propionate]; NSC 683864; mTOR Inhibitor CCI-779
EINECS	Contact for details

Quality Control

Our Temsirolimus is manufactured and tested under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a freezer at -20°C or below. This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability. Allow the sealed container to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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