New user? / Forgot your password?
0 Item | 0,00 €
Fenoterol acetate – Reference Materials for Residue and Pharmaceutical Analysis
Fenoterol acetate High-Purity Reference Materials for Confident Compliance
Power your LCMSMS workflows with traceable, high-purity fenoterol acetate standards from HPC Standards. Achieve precise quantification, robust method validation, and regulatory confidence across pharmaceutical QC, food-of-animal-origin monitoring, and environmental testing. Our portfolio includes fenoterol acetate, fenoterol parent, selected metabolites, and stable isotopelabelled analoguesideal for managing in-sample hydrolysis, matrix effects, and system suitability. Tested to international quality requirements, our reference materials deliver reproducible results and seamless audit readiness for demanding B2B laboratories.
Product | Catalog No./ CAS No. | Quantity | Price | |
|---|---|---|---|---|
ISO 17034 Reference Material |  | 692924 | 1X5MG | Please log in. |
ISO 17034 Certified Reference Material D6-Fenoterol acetate solution |  | 692925 | 1X1ML | Please log in. |
ISO 17034 Reference Material |  | 692696 | 1X5MG | |
ISO 17034 Certified Reference Material Fenoterol acetate solution |  | 692697 | 1X1ML |
High-quality reference materials for fenoterol acetate to support precise quantification, method validation, and regulatory compliance in pharmaceutical, food, and environmental analysis.
Overview
Fenoterol acetate is an esterified prodrug of the selective β2-adrenergic agonist fenoterol. The acetate group enhances lipophilicity and can hydrolyze in vivo or during sample preparation to release the active fenoterol. Analytical workflows commonly monitor both the intact acetate and the deacetylated parent to ensure complete coverage.
In residue and pharmaceutical quality control, fenoterol acetate is relevant as a target analyte, process impurity, and potential metabolically labile precursor. Its accurate measurement requires matrix-appropriate calibration and robust quality assurance using traceable reference materials.
Chemical Identity and Properties
Class: β2-adrenergic agonist prodrug (acetylated derivative of fenoterol). Functional behavior: susceptible to ester hydrolysis under acidic, basic, or enzymatic conditions. Typical analytical implication: co-monitoring fenoterol (free base/salt forms) due to in-sample deacetylation.
General characteristics: moderate polarity with increased lipophilicity vs. fenoterol; ionizable amine enabling positive ESI response; chromatographic retention improved versus the non-esterified parent. Avoid assigning fixed constants without method verification due to salt/protonation-state variability.
Uses and Applications
Pharmaceutical: intermediate or prodrug form related to bronchodilator therapies. Analytical laboratories encounter fenoterol acetate in raw material testing, impurity profiling, stability studies, and metabolite mapping.
Food/Residue control: β-agonists are monitored in products of animal origin. Where applicable, fenoterol species (including esters and parent) may be included in targeted residue screens to verify compliance.
Forensic/Anti-doping: β-agonists are controlled substances in sports; laboratories may include fenoterol-related markers in screening panels, depending on jurisdiction and test scope.
Regulatory Landscape
Regulatory controls for β-agonists vary by region. In many jurisdictions, β-agonists are prohibited for growth promotion in food-producing animals; maximum residue limits (MRLs) and zero-tolerance policies may apply. Pharmaceutical quality control follows pharmacopeial and ICH guidelines for impurities and stability.
Laboratories should consult current EU, US, and international regulations (e.g., EU veterinary drug legislation, FDA guidance, Codex, WADA where relevant) to define reporting limits and target analyte lists. When explicit MRLs for fenoterol acetate are absent, authorities may regulate the marker residue (e.g., fenoterol). Always document the legal basis used for method scope and LOQ selection.
Monitoring and Target Matrices
Typical matrices: pharmaceutical raw materials, finished dosage forms, process streams; biological matrices (urine, plasma) for clinical/toxicology; food of animal origin (muscle, liver, kidney), and sometimes milk and honey for residue surveillance.
Environmental matrices (wastewater, surface water, sludge) may be included in investigative or research monitoring due to pharmaceutical emissions and transformation of prodrug esters.
Analytical Methods
Primary technique: LC–MS/MS with positive ESI, multiple reaction monitoring (MRM) for both fenoterol acetate and fenoterol. Use qualifier/quantifier ion transitions and retention time matching to confirm identity.
Chromatography: reversed-phase C18 or polar-embedded phases with acidic mobile phase (e.g., formic acid or ammonium formate) to improve peak shape. Consider column and temperature control to separate isomers and minimize in-run hydrolysis artifacts.
Confirmation: high-resolution MS (full-scan with targeted MS/MS) or orthogonal fragmentation can support structural assignment, especially for metabolites and in-source deacetylation.
Sample Preparation
Pharmaceuticals: dilute-and-shoot or SPE following suitable solvent selection; ensure pH control to limit ester hydrolysis.
Biological/food matrices: protein precipitation followed by SPE or QuEChERS-style extraction with clean-up (e.g., mixed-mode cation exchange for amine-containing β-agonists). Include enzyme inhibitors or rapid chilling to suppress esterases.
Stability precautions: minimize sample exposure to alkaline conditions and elevated temperatures; process promptly on ice; use stabilizing buffers where validated. Evaluate autosampler stability and reinjection reproducibility.
Calibration and Quantitation
Use matrix-matched calibration or standard addition when matrix effects are significant. Internal standardization with a stable isotope-labelled analogue is recommended to correct for extraction losses and ion suppression.
Report both fenoterol acetate and fenoterol if hydrolysis during extraction cannot be fully prevented; validate mass balance and apply correction factors as appropriate.
Quality Control and Reference Materials
Employ traceable reference materials with certified purity and identity for fenoterol acetate to establish calibration accuracy, system suitability, and ongoing QC (blanks, spikes, duplicates, control charts).
Isotopically labelled reference materials (where available) improve precision and accuracy across matrices. Include independent lot verifications and periodic bracketing standards to detect drift.
Stability and Storage
Store neat materials and solutions at low temperature, protected from moisture and light. Use anhydrous solvents and prepare fresh working solutions as needed. Monitor long-term stability and freeze–thaw robustness via control charts.
Avoid prolonged exposure to basic pH and elevated temperature, as these promote ester cleavage to fenoterol. Document solution stability for method validation (short-term, long-term, autosampler).
Health Impact (Human Toxicity)
Fenoterol and its esters act on β2-adrenergic receptors. Potential acute effects at elevated exposure include tachycardia, tremor, hypokalemia, and nervousness; high doses may affect cardiovascular function. Occupational exposure should be minimized.
Risk management: implement closed handling, local exhaust ventilation, and PPE. Follow workplace exposure controls for potent amines/β-agonists and conduct medical surveillance as required by institutional policy.
Environmental Impact
Pharmaceutical β-agonists and prodrugs may enter wastewater; ester forms can hydrolyze to the active base. Environmental persistence is matrix- and pH-dependent. Monitor influent/effluent and receiving waters where relevant.
Effects on wildlife: data are limited; precautionary monitoring is advisable in ecotoxicologically sensitive areas, focusing on potential endocrine and behavioral effects associated with adrenergic activity.
Safety Measures and Handling
Handle fenoterol acetate in a fume hood with appropriate PPE (lab coat, nitrile gloves, safety glasses). Avoid inhalation and skin contact. Use amber containers and inert atmosphere where feasible.
Spill response: absorb with inert material, collect for disposal according to local regulations. Waste solutions should be contained and labeled as hazardous pharmaceutical waste.
Reporting and Compliance
Define and document method performance: selectivity, linearity, LOQ, accuracy, precision, recovery, matrix effects, carryover, and measurement uncertainty. Apply confirmatory criteria (ion ratios, retention tolerance) per regulatory guidance.
Results should clearly indicate the analyte form(s) quantified (acetate vs. parent), conversion assumptions, and any isotope dilution applied. Maintain full traceability from reference materials to reported values.
Related Compounds and Metabolites
Monitor fenoterol (parent), potential phase I/II metabolites (e.g., deacetylated forms, conjugates), and formulation-related counterions if applicable. Include structurally related β-agonists in multi-residue panels to increase surveillance efficiency.
Cross-Contamination and Risk Management
Implement segregated preparation areas, disposable glassware where practical, and rigorous rinse protocols. Use procedural blanks and contamination tracers. Validate carryover thresholds and incorporate needle-wash steps in LC–MS/MS sequences.
Analytical Standards
HPC Standards GmbH supplies high-purity reference materials for fenoterol acetate, fenoterol, selected metabolites, and stable isotope-labelled derivatives to support calibration, system suitability, and routine QC across pharmaceutical, food, and environmental matrices.
All reference materials are tested according to international quality requirements and meet the highest industrial standards, enabling laboratories to achieve competent, compliant, and reproducible residue analysis.