Description

Cefprozil Hydrate is a second-generation, broad-spectrum cephalosporin antibiotic. It is valued for its enhanced stability against β-lactamases and improved pharmacokinetic profile compared to earlier generations. This active pharmaceutical ingredient (API) is essential for the formulation of oral antibiotic medications targeting a wide range of bacterial infections. Cefprozil Hydrate CAS NO 121123-17-9 is a critical component for pharmaceutical manufacturers in the anti-infective sector.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of oral solid dosage forms (tablets, capsules) and oral suspensions.
• Anti-infective Formulations: Used in medications prescribed for respiratory tract infections (e.g., otitis media, pharyngitis, sinusitis, bronchitis).
• Skin and Soft Tissue Infection Treatments: Incorporated into formulations for uncomplicated skin and skin structure infections.
• Generic Drug Production: Serves as a key raw material for generic pharmaceutical companies producing bioequivalent versions of branded cefprozil medications.
• Veterinary Pharmaceuticals: Potential application in developing antibacterial treatments for companion animals, subject to regional regulatory approvals.
• Research & Development: Used in preclinical and clinical studies for developing new antibiotic combinations or novel drug delivery systems.

Basic Information

Product Name	Cefprozil Hydrate
CAS No.	121123-17-9
Molecular Formula	C18H19N3O5S • xH2O
Molecular Weight	407.43 g/mol (anhydrous basis)
Synonyms	Cefprozil Monohydrate; (6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-(1-propen-1-yl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Monohydrate; BMY-28100; Cefzil (brand name); Procef; BMY 28100; Cefprozilum; Cephprozil
EINECS	Contact for details

Quality Control

Our Cefprozil Hydrate is manufactured and tested under a strict quality management system. It is typically produced to meet or exceed relevant pharmacopoeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring full traceability and compliance for GMP (Good Manufacturing Practice) applications.

Storage

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

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)	3.0% - 6.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Specific Optical Rotation	-75° to -85° (c=1, in water)
pH (1% aqueous solution)	3.5 - 5.5

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