Description

7-o-Desmethyl Temsirolimus is a key pharmaceutical intermediate and metabolite of the mTOR inhibitor Temsirolimus. This compound is critical for research and development in targeted cancer therapies, particularly for renal cell carcinoma and other malignancies. It serves as a vital reference standard and building block for pharmaceutical companies, academic research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug discovery and bioanalytical method development.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and qualification of Temsirolimus and its metabolites in pharmacokinetic and bioequivalence studies.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a critical synthetic precursor in the advanced manufacturing of Temsirolimus and related rapamycin analogs.
• Metabolite Research: Essential for studying the metabolic pathways, efficacy, and toxicity profiles of Temsirolimus in preclinical and clinical research.
• Oncology Drug Discovery: Employed as a tool compound in biochemical assays to investigate mTOR pathway inhibition and to develop next-generation targeted cancer therapeutics.
• Analytical Method Development: Used to develop and validate high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS/MS) methods for drug analysis.
• Impurity Profiling: Acts as a specified impurity standard to ensure the purity and quality control of Temsirolimus API batches according to ICH guidelines.

Basic Information

Product Name	7-o-Desmethyl Temsirolimus
CAS No.	408321-08-4
Molecular Formula	C45H73NO13
Molecular Weight	836.06 g/mol
Synonyms	7-O-Desmethyl Temsirolimus; 42-O-(2-Hydroxyethyl)-7-desmethylrapamycin; 7-Desmethoxy Temsirolimus; Temsirolimus Impurity; Temsirolimus Metabolite; Torisel Impurity; CCI-779 Metabolite; (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone 42-(2-Hydroxyethyl) ether
EINECS	Contact for details

Quality Control

Our 7-o-Desmethyl Temsirolimus is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis. Certificates of Analysis (COA) are provided, detailing all specifications and test results. We support compliance with cGMP and ICH Q3A/B guidelines for impurities in new drug substances, ensuring the material is suitable for rigorous pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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