Description

Ciprofloxacin Hydrochloride Hydrate is the hydrochloride salt hydrate form of a broad-spectrum fluoroquinolone antibiotic. This compound is a critical active pharmaceutical ingredient (API) and intermediate, valued for its potent antibacterial activity against a wide range of Gram-positive and Gram-negative bacteria. It is essential for pharmaceutical manufacturers and research institutions developing antibacterial formulations, including tablets, injections, and ophthalmic solutions.

Application

• Pharmaceutical API: Primary use as the active ingredient in the synthesis of finished antibiotic dosage forms.
• Oral Solid Dosages: Formulation into tablets and capsules for systemic antibacterial treatment.
• Injectable Solutions: Manufacturing of sterile intravenous and intramuscular injections for severe infections.
• Ophthalmic Preparations: Production of eye drops and ointments for treating bacterial conjunctivitis and corneal ulcers.
• Veterinary Medicine: Used in antibacterial treatments for livestock and companion animals.
• Research & Development: Serves as a reference standard and key intermediate in microbiological and pharmacological studies.
• Bulk Drug Substance: Supplied to compounding pharmacies and large-scale generic drug manufacturers.

Basic Information

Item	Detail
Product Name	Ciprofloxacin Hydrochloride Hydrate
CAS No.	86393-32-0
Molecular Formula	C17H18FN3O3 · HCl · xH2O
Molecular Weight	367.81 (Anhydrous base hydrochloride)
Synonyms	Ciprofloxacin HCl Hydrate; 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride hydrate; Ciprofloxacin Monohydrochloride Hydrate; Ciprofloxacin HCl Monohydrate; Bay q 3939; Ciprofloxacin Hydrochloride Monohydrate; Cipro
EINECS	Contact for details

Quality Control

Our Ciprofloxacin Hydrochloride Hydrate is manufactured under strict quality management systems. Each batch is tested to ensure compliance with relevant pharmacopeial standards such as USP, EP, and BP. Comprehensive testing includes identification, assay, impurity profile, residual solvents, and microbiological examination. A Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and product integrity.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which can affect stability and potency.

Specification

Item	Specification
Appearance	White to slightly yellow, 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)	4.5% - 6.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Limits	Conforms to EP/USP requirements

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