Description

Cefalexin CAS NO 108260-04-4 is a first-generation cephalosporin antibiotic belonging to the β-lactam class. It is valued for its broad-spectrum activity against a range of Gram-positive and some Gram-negative bacteria, making it a critical active pharmaceutical ingredient (API). This compound is essential for manufacturers in the pharmaceutical industry producing oral antibiotic formulations for human and veterinary use.

Application

• Pharmaceutical API: Primary use as the active ingredient in the production of oral antibiotic capsules, tablets, and suspensions for human medicine.
• Veterinary Pharmaceuticals: Formulated into medications for treating bacterial infections in companion animals and livestock.
• Generic Drug Manufacturing: A key component for companies producing generic cephalexin monohydrate medications.
• Clinical Research: Serves as a reference standard and raw material in pharmaceutical R&D for antibiotic studies.
• Bulk Powder Formulations: Used by compounding pharmacies for preparing specific dosage forms as required.

Basic Information

Product Name	Cefalexin
CAS No.	108260-04-4
Molecular Formula	C16H17N3O4S
Molecular Weight	347.39 g/mol
Synonyms	Cephalexin; Cefalexin Monohydrate; 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic Acid; Ceporex; Keflex; Cepol; Cefabiotic; Cefaseptin; Cepexin
EINECS	Contact for details

Quality Control

Our Cefalexin is produced and tested to meet stringent pharmaceutical standards. Quality assurance protocols are designed to ensure identity, purity, strength, and composition, with testing typically referencing USP, EP, and BP monographs. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each batch to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.5% - 6.5%
pH (5% suspension)	3.5 - 6.0
Specific Optical Rotation	+149° to +158°
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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