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Candesartan Reference Materials
Candesartan High-Purity Reference Materials for Confident LC-Based Quantification
Power your pharmaceutical and environmental workflows with rigorously characterized Candesartan reference materials from HPC Standards. Our portfolio includes neat solids, calibrated solutions, and candesartan cilexetil, with isotopically labeled options on requestideal for calibration, method validation, recovery studies, and routine QC. Each batch is backed by traceable data, documented uncertainty, and comprehensive Certificates of Analysis, supporting ISOIEC 17025 and ISO 17034-compliant processes. Rely on proven stability, precise gravimetric preparation, and expert technical support to achieve reliable results across pharma QC, stability studies, and wastewater monitoring.
Product | Catalog No./ CAS No. | Quantity | Price | |
|---|---|---|---|---|
ISO 17034 Certified Reference Material Candesartan solution |  | 686140 | 1X5ML | Please log in. |
 | 689004 | 1X50MG | Please log in. |
High-quality reference materials for precise identification, quantification, and method validation of candesartan and related compounds in pharmaceutical, environmental, and wastewater analyses.
Overview
Candesartan is an angiotensin II receptor blocker (ARB) used clinically to manage hypertension and heart failure. In analytical contexts, candesartan and its prodrug candesartan cilexetil are target analytes in pharmaceutical quality control, stability studies, wastewater-based epidemiology, and environmental monitoring of pharmaceutically active compounds.
HPC Standards GmbH supplies rigorously characterized reference materials for candesartan to support accurate calibration, recovery determination, and routine QC in LC-based workflows.
Synonyms and Forms
- Active moiety: candesartan (free acid/neutral form as used in analysis)
- Prodrug: candesartan cilexetil (commonly encountered in medicinal products; hydrolyzes in vivo and during some pretreatments to candesartan)
- Salt forms: various salts may occur in formulations; analytical calibration typically uses the free form or specified salt with correction for counter-ions.
Uses
- Pharmaceutical QC: assay and impurity profiling of candesartan-containing drug products and APIs.
- Stability and degradation studies: monitoring hydrolysis of candesartan cilexetil to candesartan; forced-degradation mapping under acid/base/oxidative/thermal/light stress.
- Environmental and wastewater analysis: occurrence and fate studies in influent/effluent, sludge, surface waters, and sediments.
Physicochemical Profile
- Chemical class: biphenyl-tetrazole angiotensin II type 1 (AT1) receptor antagonist.
- Ionization: weakly acidic functional groups; favorable ionization in LC–ESI(+/−) depending on method optimization.
- Solubility: sparingly soluble in water; soluble in common organic solvents (e.g., methanol, acetonitrile, DMSO). Prepare gravimetrically to ensure accuracy.
- Stability: prodrug (cilexetil) is more prone to hydrolysis; control pH, temperature, and moisture during sample prep and storage.
Regulatory Landscape
- Pharmaceutical: subject to pharmacopeial quality requirements (e.g., assay, impurities, related substances) in finished products and APIs.
- Environment: monitoring of pharmaceuticals, including ARBs, may be mandated under national or regional programs for wastewater and surface waters. Discharge permits or local guidance can specify analytical requirements.
- Data integrity and traceability: calibration must follow ISO/IEC 17025 and ISO 17034 principles where applicable, with traceable reference materials and documented uncertainty.
Monitoring and Matrices
- Matrices: raw materials, finished dosage forms, blood/serum (clinical research), wastewater (influent/effluent), sludge, surface water, groundwater, and sediments.
- Typical concentration ranges: ng/L–µg/L in environmental waters; mg/g to mg/mL levels in pharmaceutical QC. Choose calibration ranges aligned with expected concentrations and instrument sensitivity.
Analytical Methods
- Primary techniques: LC–MS/MS for high selectivity and sensitivity; LC–UV/FLD for QC where sensitivity permits; UHPLC for throughput.
- Sample preparation: SPE (reversed-phase or mixed-mode) for environmental waters; protein precipitation/solid-phase cleanup for biological matrices; dissolution and dilution for pharmaceutical forms.
- Validation: evaluate selectivity, linearity, accuracy (recovery), precision, carryover, matrix effects, LOD/LOQ, and stability (short-term, freeze–thaw, autosampler, stock/working solutions).
Calibration and Traceability
- Use gravimetrically prepared stock solutions from certified reference materials to minimize volumetric error.
- Apply internal standards (preferably isotopically labeled candesartan) to correct for matrix effects and signal variability.
- Document measurement uncertainty and maintain traceability to SI units where feasible.
Health Impact — Human Toxicity
- Pharmacology: selective AT1 receptor antagonism; therapeutic effects include blood pressure reduction and decreased cardiovascular risk.
- Adverse effects (clinical use): hypotension, hyperkalemia, renal function changes; contraindicated in pregnancy due to fetal toxicity risk.
- Occupational exposure: low acute toxicity expected at analytical quantities; avoid inhalation/ingestion and skin/eye contact. Implement GMP/GLP-compatible handling procedures.
Environmental Impact — Effects on Wildlife and Ecosystems
- Occurrence: ARBs and their transformation products can be detected in municipal wastewater and receiving waters depending on usage and treatment efficiency.
- Fate: variable removal during wastewater treatment; potential for photolysis, biodegradation, and sorption to sludge/sediment depending on conditions.
- Ecotoxicology: limited species-specific data for candesartan; apply precautionary monitoring and risk assessment frameworks for pharmaceuticals in the environment.
Safety Measures and Handling
- Personal protection: lab coat, safety glasses, and appropriate gloves; handle powders in a fume hood or containment to prevent dust/aerosol formation.
- Spill and disposal: collect with inert absorbent; dispose according to local regulations for pharmaceutical/chemical waste.
- Transport: ship under temperature control if required; protect from light and moisture.
Stability and Storage
- Solid reference materials: store tightly closed, desiccated, and protected from light at 2–8 °C unless otherwise specified on the certificate.
- Solutions: prepare in high-purity solvents (e.g., acetonitrile, methanol). Short-term stability at 2–8 °C; for long-term storage, keep at ≤ −20 °C and protect from light. Verify solution stability during method validation.
- Hydrolysis control: candesartan cilexetil is susceptible to hydrolysis; avoid elevated temperatures and alkaline conditions during preparation and analysis.
HPC Standards Reference Materials for Candesartan
- Product scope: candesartan (neat solid), candesartan solutions at defined concentrations, and candesartan cilexetil. Isotopically labeled internal standards available on request.
- Quality: manufactured and tested in accordance with international quality requirements. Each batch is accompanied by a detailed certificate with purity, identity confirmation, and uncertainty data.
- Application support: intended for calibration, system suitability, method development, recovery studies, and proficiency testing across pharmaceutical and environmental workflows.
Documentation, Shipping, and Support
- Documentation: certificate of analysis, safety data sheet, and technical datasheet with storage and handling guidance.
- Compliance: materials support ISO/IEC 17025 and ISO 17034-compliant workflows with traceable characterization data.
- Services: custom concentrations, solvent matrices, ampoule sizes, and mixture blends on request; technical support for method setup and matrix-specific challenges.