Description

Cephalexin Monohydrate is a first-generation cephalosporin antibiotic, widely recognized for its broad-spectrum bactericidal activity. It is a critical active pharmaceutical ingredient (API) essential for formulating effective oral antibiotic medications. This compound is primarily utilized by pharmaceutical manufacturers in the production of generic and branded antibiotic drugs targeting a range of bacterial infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral antibiotic formulations (capsules, tablets, oral suspensions).
• Human Medicine: Treatment of respiratory tract infections, skin and soft tissue infections, urinary tract infections, and otitis media.
• Veterinary Medicine: Used in veterinary pharmaceuticals for treating bacterial infections in companion animals and livestock.
• Research & Development: Serves as a reference standard and key intermediate in antimicrobial research and new drug development.
• Generic Drug Manufacturing: A cornerstone product for companies producing cost-effective, quality generic antibiotics for global health systems.

Basic Information

Product Name	Cephalexin Monohydrate
CAS No.	23325-78-2
Molecular Formula	C16H17N3O4S • H2O
Molecular Weight	365.41 g/mol
Synonyms	Cephalexin Hydrate; Cefalexin Monohydrate; (6R,7R)-7-[(R)-2-Amino-2-phenylacetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate; Keflex; Ceporex; Cepol; Ceporexine; Lexin
EINECS	Contact for details

Quality Control

Our Cephalexin Monohydrate is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets or exceeds relevant pharmacopoeial standards, including USP, EP, and BP monographs. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
Water Content (KF)	4.0% - 6.0%
pH (5% suspension)	3.5 - 6.0
Related Substances (HPLC)	Meets EP/USP requirements
Residual Solvents (GC)	Meets ICH guidelines
Heavy Metals	< 20 ppm
Microbial Enumeration	Meets EP/USP requirements

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