Description

Cephalexin Monohydrochloride is the hydrochloride salt form of the first-generation cephalosporin antibiotic, Cephalexin. This form enhances the stability and handling characteristics of the active pharmaceutical ingredient, making it a critical intermediate in the production of finished dosage forms. It is essential for pharmaceutical manufacturers and research institutions developing oral antibiotic formulations. The compound is supplied under strict quality control to ensure efficacy and compliance with global pharmacopeial standards.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of oral antibiotic capsules and tablets.
• Veterinary Pharmaceutical Production for treating bacterial infections in livestock and companion animals.
• Research & Development of new antibiotic formulations and combination therapies.
• Reference Standard in quality control laboratories for analytical method development and validation.
• Bulk Pharmaceutical Chemical for contract manufacturing organizations (CMOs) producing generic medicines.

Basic Information

Product Name	Cephalexin Monohydrochloride
CAS No.	105879-42-3
Molecular Formula	C16H17N3O4S•HCl
Molecular Weight	383.85 g/mol
Synonyms	Cephalexin HCl; Cephalexin Hydrochloride; (6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hydrochloride; Cephalesin Hydrochloride; Ceporex Hydrochloride; Keflex Hydrochloride; 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid hydrochloride
EINECS	Contact for details

Quality Control

Our Cephalexin Monohydrochloride is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs where applicable. Every batch undergoes comprehensive analytical testing for identity, potency, and purity. Certificates of Analysis (COA) documenting all test results are provided to ensure full traceability and compliance with cGMP guidelines for pharmaceutical ingredients.

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 prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%

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