Category
Cephalexin
CAS Number
59865-11-1
Alternate CAS Number
NA(HCl Salt)
Molecular Formula
C₁₆H₁₇N₃O₄S
Molecular Weight
347.39 g/mol
Synonym

 Cephalexin Diketopiperazine ; Cefalexin Diketopiperazine Derivative; 2-(3,6-Dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic Acid;

Keywords
sulphur and selenium compounds
Aromatics
Heterocycles
Impurities
Fine Chemicals
Intermediates
Pharmaceutical Standards
Impurities manufacturer and Suppliers in Hyderabad india
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Cephalexin Impurity-1 (CAS No. 59865-11-1), with a molecular formula of C₁₆H₁₇N₃O₄S and a molecular weight of 347.39 g/mol, is a key pharmaceutical reference standard used for the quality control, impurity profiling, analytical method development, method validation, stability-indicating studies, degradation analysis, and regulatory compliance testing of Cephalexin drug substances and formulations. It is essential for ensuring compliance with global regulatory requirements including ICH, USFDA, EMA, USP, and EP guidelines, enabling accurate identification and quantification of related substances during pharmaceutical development and manufacturing processes. Manasa Life Sciences, a global manufacturer and supplier based in Hyderabad, provides high-purity Cephalexin Impurity-1 reference standards that are fully characterized using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy, ensuring precise structural confirmation, reliable impurity profiling, and batch-to-batch consistency, supported by complete documentation including Certificate of Analysis (COA), GMP and GDP compliance documents, MSDS, and SDS for global pharmaceutical and research applications.