Description

Cephalexin CAS NO 15686-71-2 is a first-generation cephalosporin antibiotic belonging to the β-lactam class, valued for its broad-spectrum activity against Gram-positive and some Gram-negative bacteria. Its primary commercial importance lies in its extensive use as a key active pharmaceutical ingredient (API) in the formulation of oral antibiotic medications. This compound is essential for manufacturers in the pharmaceutical industry, particularly those producing generic drugs for human and veterinary use to treat respiratory, skin, and urinary tract infections.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the production of oral antibiotic capsules, tablets, and suspensions for human use.
• Formulation of veterinary pharmaceutical products to treat bacterial infections in livestock and companion animals.
• Utilization in generic drug manufacturing under various pharmacopeial standards (e.g., USP, BP, EP).
• Research and development applications in pharmacology and microbiology for studying antibiotic efficacy and resistance.
• Intermediate in the synthesis of more complex cephalosporin derivatives for advanced pharmaceutical research.

Basic Information

Product Name	Cephalexin
CAS No.	15686-71-2
Molecular Formula	C16H17N3O4S • H2O
Molecular Weight	365.41 g/mol (Monohydrate)
Synonyms	Cephalexin Monohydrate; Cefalexin; 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic Acid; Keflex; Ceporex; Sporidex; Cepol; Ceporexine; Cepexin; IUPAC: (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
EINECS	239-773-6

Quality Control

Our Cephalexin is manufactured and tested to meet stringent pharmacopeial standards, including USP, BP, and EP monographs. Each batch undergoes comprehensive analytical testing to ensure identity, potency, purity, and the control of specified impurities. A Certificate of Analysis (COA) documenting all test results is provided with every shipment, ensuring full traceability and compliance for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to prevent degradation. For long-term stability, consider storage under an inert atmosphere.

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)	4.0% - 6.0%
pH (1% 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 guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.2%

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