Description

Cephradine Hydrate is a first-generation, broad-spectrum cephalosporin antibiotic. This semi-synthetic compound is valued for its bactericidal activity against a range of Gram-positive and some Gram-negative bacteria. It is a critical active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the formulation of oral dosage forms such as capsules and tablets.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral antibiotic medications.
• Capsule Formulation: Direct compression or granulation for the production of cephradine capsules.
• Tablet Formulation: Used in the development and commercial production of coated or uncoated tablets.
• Generic Drug Production: Serves as the key raw material for generic pharmaceutical companies worldwide.
• Clinical Research: Utilized in R&D for developing new antibiotic formulations or combination therapies.
• Veterinary Pharmaceuticals: Potential application in certain antibacterial treatments for animals.

Basic Information

Product Name	Cephradine Hydrate
CAS No.	31828-50-9
Molecular Formula	C16H19N3O4S • xH2O
Molecular Weight	Anhydrous: 349.40 g/mol
Synonyms	Cephradine; Cephradine Monohydrate; (±)-Cephradine; Cefradine; Sefril; Velosef; Anspor; Cefradin; Cepharadine; 7-[(2,2-Dimethylcyclopropanecarbonyl)amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EINECS	250-819-1

Quality Control

Our Cephradine Hydrate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and the absence of critical impurities. A Certificate of Analysis (COA) documenting all test results is provided with each shipment to guarantee traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (on anhydrous basis)	96.0% - 102.0%
Water Content (KF)	4.0% - 6.0%
pH (1% suspension)	3.5 - 6.0
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP

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