Description

Temsirolimus Impurity 1 CAS NO 1027067-40-8 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Temsirolimus. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality assurance laboratories involved in the development and production of Temsirolimus-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Temsirolimus API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Temsirolimus batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Temsirolimus.

Basic Information

Product Name	Temsirolimus Impurity 1
CAS No.	1027067-40-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Temsirolimus Related Compound 1; Temsirolimus Impurity A; Temsirolimus EP Impurity A; Temsirolimus USP Impurity 1; CCI-779 Impurity 1; (1R,2R,4S)-4-[(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-Dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl]-2-methoxycyclohexyl dimethylphosphinate; Torisel Impurity 1
EINECS	Contact for details

Quality Control

Our Temsirolimus Impurity 1 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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