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Tosufloxacin hydrochloride – Reference Materials for Residue and Contaminant Analysis
Tosufloxacin hydrochloride Certified Reference Materials for Confident Residue and QC Analytics
Ensure traceable, regulation-ready results with HPC Standards Tosufloxacin hydrochloride reference materials. Produced under stringent quality control and supplied with comprehensive CoAs, our neat and ready-to-use solutions support LC-UVDAD and LC-MSMS workflows across pharma QC, food and feed residue monitoring, and environmental surveillance. Benefit from custom concentrations, isotopically labeled options, matrix-matched controls, and globally compliant documentationoptimized for ISOIEC 17025 and GMP laboratories seeking accuracy, robustness, and audit-proof data.
Product | Catalog No./ CAS No. | Quantity | Price | |
|---|---|---|---|---|
 | 692705 | 1X5MG | ||
D4-Tosufloxacin hydrochloride solution |  | 692706 | 1X1ML | |
 | 692707 | 1X5MG | ||
Tosufloxacin hydrochloride solution |  | 692708 | 1X1ML |
HPC Standards provides certified reference materials for Tosufloxacin hydrochloride to support accurate quantification in pharmaceutical quality control, food and feed residue monitoring, and environmental analysis. Our materials meet international quality requirements and are suited for regulated laboratories.
Overview
Tosufloxacin hydrochloride is a fluoroquinolone antibiotic salt used in certain markets for the treatment of bacterial infections. As an analytically relevant target, it is monitored in pharmaceutical formulations, biological matrices, food-producing animal matrices (where applicable), and environmental samples impacted by wastewater discharges.
Reference materials enable traceable calibration, method validation, and routine QC of tosufloxacin determinations across a wide range of analytical workflows.
Chemical Identity and Properties
Class: Fluoroquinolone antibacterial (hydrochloride salt of tosufloxacin). The hydrochloride form improves aqueous solubility and handling for analytical applications.
Key attributes for analysis: strong UV absorbance, amenable to LC detection (UV/DAD) and LC-MS/MS; low volatility; moderate polarity; potential for chelation with metals—use metal-passivated LC hardware where relevant.
Uses and Applications
Primary use: active pharmaceutical ingredient (API) for antibacterial therapy in certain countries. Analytical interest spans API assay and impurity profiling, dissolution testing, stability studies, and residual monitoring.
Residue and exposure monitoring: screening in animal-derived foods where authorized use exists or where off-label/illegal use is a concern; surveillance in surface water, wastewater, and sediments due to discharge from healthcare and manufacturing sources.
Regulatory Landscape
Authorization and maximum residue limits (MRLs) for tosufloxacin vary by jurisdiction and product type. In some regions tosufloxacin may not be authorized for use in food-producing animals; where not authorized, specific MRLs are often not established and default regulatory provisions can apply.
Pharmacopoeial and GMP environments require traceable reference materials for assay and related substances. Environmental monitoring programs may follow national or regional water-quality frameworks for pharmaceuticals.
Monitoring and Target Matrices
Matrices: finished drug products, raw materials, plasma/serum/urine, milk, muscle, liver, kidney, eggs, fish, surface water, wastewater influent/effluent, sediments, sludge.
Typical concentration ranges: ng/L to µg/L in waters; ng/g to µg/kg in food matrices; percentage levels in pharmaceutical products.
Sample Preparation
Pharmaceuticals: dilution or extraction in aqueous-organic solvents; filtration; stabilization with acidified aqueous mobile phases as needed.
Biological and food matrices: protein precipitation (ACN/MeOH), liquid–liquid extraction, or SPE (e.g., mixed-mode cation-exchange or reversed-phase); matrix-matched calibration recommended.
Environmental samples: filtration, pH control, and SPE (HLB/mixed-mode) with careful elution to recover zwitterionic/ionic species.
Analytical Methods
LC-UV/DAD for high-level assay and dissolution testing; selectivity enhanced via gradient RP conditions and acidic buffers.
LC-MS/MS (MRM) for trace analysis in complex matrices; optimize source conditions to stabilize protonated molecular ions; consider isotopically labeled internal standards for improved accuracy.
Confirmatory analysis with accurate-mass LC-HRMS for non-target and transformation product screening.
Calibration and Quantification
Use multi-point calibration with bracketing QC standards. Employ internal standardization (preferably isotopically labeled analogues) to correct for matrix effects and extraction variability.
Prepare standards gravimetrically; verify linearity, recovery, and measurement uncertainty according to applicable guidelines (e.g., ICH, ISO/IEC 17025).
Quality Assurance and Accreditation
HPC reference materials are produced under stringent quality control and supplied with comprehensive documentation supporting traceability, purity, identity, and concentration.
Suitable for use in ISO/IEC 17025 and GMP settings to fulfill requirements for method validation, system suitability, and routine QC.
Reference Materials from HPC Standards
Available as neat material and ready-to-use solutions at defined concentrations. Custom concentrations, solvents, and multi-analyte mixes on request.
Optional matrix-matched controls and proficiency test materials can be provided to support end-to-end method verification.
Storage and Stability
Store according to the certificate of analysis (CoA), typically protected from light at controlled temperature. Avoid repeated freeze–thaw cycles for solutions; aliquot upon receipt if frequent use is anticipated.
Monitor expiry and re-test dates; replace working solutions periodically based on stability data.
Packaging and Formats
Sealed amber glass vials with tamper-evident closures. Typical fill volumes support multiple calibrations and QCs.
Solvent options include acetonitrile, methanol, water-based mixtures, or customer-specified blends compatible with LC-MS.
Documentation and Compliance
Each lot is delivered with CoA including identity confirmation, purity/assay, concentration, uncertainty (for solutions), and storage conditions. Safety data sheet (SDS) provided.
Batch-specific chromatograms and additional documentation available upon request to support audits and regulatory submissions.
Health Impact — Human Toxicity
Fluoroquinolones, as a class, may be associated with adverse effects such as gastrointestinal disturbances, CNS effects, tendinopathy, and potential QT interval effects. Toxicological profiles and risk management depend on dose, route, and clinical context.
Laboratory handling should minimize exposure; refer to the SDS for hazard statements and first-aid measures. This information is intended for analytical use and not for therapeutic guidance.
Environmental Impact — Fate and Effects on Wildlife
Fluoroquinolones are persistent in aquatic environments, can adsorb to sediments, and may contribute to antimicrobial resistance selection pressure. Photolysis and biodegradation are matrix- and pH-dependent.
Toxicity to aquatic organisms can occur at elevated concentrations; monitoring programs target influent/effluent, surface waters, and sediments to assess occurrence and trends.
Safety Measures and Handling
Use appropriate PPE (lab coat, gloves, eye protection) and work in well-ventilated areas or fume hoods. Avoid aerosol and dust generation with neat powders.
Follow good laboratory practice for weighing, dilution, labeling, and waste disposal in accordance with local regulations.
Related Compounds and Metabolites
Method scopes may include other fluoroquinolones and potential transformation products. Isotopically labeled internal standards are recommended where available to improve quantitation.
Shipping and Lead Times
Products ship with temperature and light protection as required. Worldwide delivery with documentation to support customs and regulatory clearance.
Expedited production for custom mixes and concentrations is available upon request.
Typical Customers and Use Cases
Pharmaceutical manufacturers and CROs for QC and stability studies; contract laboratories and public authorities for residue and environmental surveillance; academic labs for method development and occurrence studies.
Ordering Information
Contact HPC Standards for catalog numbers, available concentrations, and custom formulations for Tosufloxacin hydrochloride. Our technical team supports method development, selection of suitable reference materials, and compliance documentation.