{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.fotemustine","code":"thing-q1439555","url":"https://ver.cy/models/thing/q1439555/","name":"fotemustine","alternateNames":["(S)-fotemustine","(R)-fotemustine"],"kind":"thing","status":"published","version":"0.1.0-research.1","language":"en","classifiers":{"family":"Thing Registry","category":"Physical world and living systems","entryKind":"thing","plane":"PHY","domain":["PHY.MAT"],"industry":[],"navPath":"","tags":[],"facets":{}},"whatItIs":"Fotemustine is a synthetic, phosphonate-containing nitrosourea antineoplastic substance that alkylates DNA and has been used to treat melanoma and certain primary brain tumours.","purpose":"Enable an agent to identify fotemustine, assess the identity and condition of a material sample, and determine which handling or use decisions have sufficient evidence.","scope":{"in":["Molecular structure, identifiers and unresolved stereochemical distinctions","Sample composition, assay, impurities and grade","Physical state and measured properties under specified conditions","Storage history, solution stability and degradation","Alkylating activity and evidence relevant to exposure controls","Substance identity across supplier, safety and regulatory records"],"out":["Finished medicines, their excipients, packaging and marketing authorisations","Patient-specific prescribing, dosing and treatment selection","Cancer diseases and their clinical management","Manufacturing processes and production equipment","Other nitrosoureas as independently registered substances","Degradation products as independent chemical entities"],"boundaries":[]},"distinguishingFeatures":["Require a structure match to 1-(2-chloroethyl)-3-(1-diethoxyphosphorylethyl)-1-nitrosourea; membership in the nitrosourea class alone is insufficient. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Fotemustine)","Check for the phosphonate-containing substituent as well as the chloroethyl nitrosourea group when distinguishing fotemustine from related alkylating agents. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Fotemustine)","Use molecular formula C9H19ClN3O5P and PubChem CID 104799 as consistency checks, with structure taking precedence over a name-only match. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Fotemustine)","Distinguish a fotemustine substance sample from a medicine containing it by checking the complete composition and the entity described by the record.","Distinguish intact fotemustine from aged or degraded material through a validated identity and impurity assessment rather than appearance alone."],"structure":{"bundles":[{"id":"fotemustine-identity","name":"Fotemustine identity","description":"Establishes which chemical entity a fotemustine record or sample represents.","layers":[{"id":"molecular-recognition","name":"Molecular recognition","description":"Tests correspondence with fotemustine's molecular structure.","findings":[{"id":"structure-and-stereochemistry","name":"Structure and stereochemistry","description":"Record the complete structure and whether stereochemistry is specified, unspecified or experimentally characterised.","questions":[{"text":"Does the candidate structure contain fotemustine's chloroethyl nitrosourea and diethoxyphosphorylethyl substituent?","id":"structure-and-stereochemistry-q01","kind":"definition"},{"text":"What stereochemical composition does the source specify, and does that specification match the sample?","id":"structure-and-stereochemistry-q02","kind":"boundary"}]}]},{"id":"identifier-reconciliation","name":"Identifier reconciliation","description":"Connects the registry entity to external substance records without assuming all listed identifiers are interchangeable.","findings":[{"id":"substance-versus-product-record","name":"Substance versus product record","description":"Resolve identifier scope and distinguish molecular records from medicines sold under a trade name.","questions":[{"text":"Which authoritative records establish each CAS or EC identifier's correspondence to the intended fotemustine entity?","id":"substance-versus-product-record-q01","kind":"provenance"},{"text":"Does a supplied name identify fotemustine itself, a stereochemical variant or a finished medicine containing it?","id":"substance-versus-product-record-q02","kind":"boundary"}]}]}]},{"id":"fotemustine-material-quality","name":"Fotemustine material quality","description":"Captures how much intact fotemustine a sample contains and the evidence supporting its grade.","layers":[{"id":"assay-and-related-substances","name":"Assay and related substances","description":"Separates intact fotemustine measurement from impurity and degradation measurements.","findings":[{"id":"selective-analytical-evidence","name":"Selective analytical evidence","description":"Require methods capable of distinguishing fotemustine from relevant related substances and degradation products.","questions":[{"text":"Which analytical method identifies and quantifies intact fotemustine, and what demonstrates its specificity?","id":"selective-analytical-evidence-q01","kind":"measurement"},{"text":"Which impurities are identified or unresolved, and what are their concentrations and reporting limits?","id":"selective-analytical-evidence-q02","kind":"measurement"},{"text":"Is the reported purity an absolute assay, a chromatographic area percentage or another quantity?","id":"selective-analytical-evidence-q03","kind":"definition"}]}]},{"id":"grade-and-lot-evidence","name":"Grade and lot evidence","description":"Relates sample provenance and certification to a defined material use.","findings":[{"id":"lot-specific-suitability","name":"Lot-specific suitability","description":"Make suitability depend on the lot's documented specification and current evidence.","questions":[{"text":"Which lot-specific certificate and specification support the stated fotemustine grade?","id":"lot-specific-suitability-q01","kind":"provenance"},{"text":"Does the proposed use require qualifications beyond chemical assay that this material has not demonstrated?","id":"lot-specific-suitability-q02","kind":"action"}]}]}]},{"id":"fotemustine-physical-state-and-stability","name":"Fotemustine physical state and stability","description":"Tracks condition-dependent properties and persistence of intact fotemustine.","layers":[{"id":"conditioned-physical-properties","name":"Conditioned physical properties","description":"Records phase, thermal behaviour and solubility with their experimental conditions.","findings":[{"id":"property-measurement-context","name":"Property measurement context","description":"Separate measured properties from predictions and distinguish physical transitions from decomposition.","questions":[{"text":"What physical form was tested, and at what temperature, pressure and purity?","id":"property-measurement-context-q01","kind":"measurement"},{"text":"Do reported thermal values describe melting, boiling or decomposition, and what method distinguishes them?","id":"property-measurement-context-q02","kind":"measurement"},{"text":"For reported solubility, which solvent and conditions were used, and was intact fotemustine verified?","id":"property-measurement-context-q03","kind":"measurement"}]}]},{"id":"storage-and-solution-age","name":"Storage and solution age","description":"Links environmental history and preparation age to evidence of remaining intact substance.","findings":[{"id":"stability-supported-use-window","name":"Stability-supported use window","description":"Represent storage limits and solution holding times only for the compositions and conditions actually studied.","questions":[{"text":"What data establish fotemustine stability in the recorded container, temperature and light conditions?","id":"stability-supported-use-window-q01","kind":"provenance"},{"text":"How do solvent, concentration, pH where relevant and elapsed time affect the measured intact concentration?","id":"stability-supported-use-window-q02","kind":"measurement"},{"text":"Following an excursion or unsupported holding time, what evidence is required to release or reject the material?","id":"stability-supported-use-window-q03","kind":"action"}]}]}]},{"id":"fotemustine-biological-reactivity","name":"Fotemustine biological reactivity","description":"Connects chemical identity to documented biological effects and the limits of those observations.","layers":[{"id":"alkylating-activity","name":"Alkylating activity","description":"Organises evidence concerning fotemustine's alkylating action.","findings":[{"id":"dna-damage-evidence","name":"DNA damage evidence","description":"Fotemustine is described as a DNA-damaging alkylating nitrosourea; detailed mechanisms require experiment-specific support. [NCI](https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fotemustine)","questions":[{"text":"Which experiments support the proposed DNA lesions or downstream effects attributed to fotemustine?","id":"dna-damage-evidence-q01","kind":"provenance"},{"text":"Does an observed effect arise from intact fotemustine, a reactive intermediate or another constituent of the tested preparation?","id":"dna-damage-evidence-q02","kind":"boundary"}]}]},{"id":"biological-context-and-transfer","name":"Biological context and transfer","description":"Constrains interpretation of activity and distribution claims to the systems studied.","findings":[{"id":"exposure-and-model-dependence","name":"Exposure and model dependence","description":"Retain preparation, exposure and biological-system details when linking fotemustine to activity or tissue distribution.","questions":[{"text":"Which organism, tissue or cell system, concentration and exposure duration support the recorded result?","id":"exposure-and-model-dependence-q01","kind":"measurement"},{"text":"What direct evidence supports any claimed brain penetration, and does it measure parent fotemustine or another analyte?","id":"exposure-and-model-dependence-q02","kind":"provenance"},{"text":"Which conclusions require a separate clinical or medicinal-product model before an agent can act on them?","id":"exposure-and-model-dependence-q03","kind":"boundary"}]}]}]},{"id":"fotemustine-handling-and-regulatory-identity","name":"Fotemustine handling and regulatory identity","description":"Links the actual material to applicable hazard evidence and authorised handling procedures.","layers":[{"id":"hazard-and-exposure-controls","name":"Hazard and exposure controls","description":"Collects current evidence for controlling exposure to the specified fotemustine material.","findings":[{"id":"material-specific-control-basis","name":"Material-specific control basis","description":"Tie hazard classifications and control procedures to material form, operation and jurisdiction.","questions":[{"text":"Which current safety document supports the hazard classification for this fotemustine material?","id":"material-specific-control-basis-q01","kind":"provenance"},{"text":"Is a fotemustine-specific occupational exposure limit established by an applicable authority, or is none documented?","id":"material-specific-control-basis-q02","kind":"measurement"},{"text":"Which approved procedure covers weighing, solution transfer, spills and contaminated waste for the intended operation?","id":"material-specific-control-basis-q03","kind":"action"}]}]},{"id":"jurisdiction-and-use-status","name":"Jurisdiction and use status","description":"Separates substance listing, supplier claims and medicinal-product authorisation.","findings":[{"id":"regulatory-record-scope","name":"Regulatory record scope","description":"Record the entity, jurisdiction and date to which a regulatory statement actually applies.","questions":[{"text":"Does the cited regulatory record concern fotemustine as a substance, a specific mixture or an authorised medicine?","id":"regulatory-record-scope-q01","kind":"boundary"},{"text":"Which authority and effective date support the status being used in the decision?","id":"regulatory-record-scope-q02","kind":"provenance"},{"text":"What additional product or institutional authorisation is required for the proposed use of this lot?","id":"regulatory-record-scope-q03","kind":"action"}]}]}]},{"id":"evidence-and-external-alignment","name":"Evidence and external alignment","description":"What the world already says about this thing, gathered so the model can be checked against it.","layers":[{"id":"reported-evidence","name":"Reported evidence","description":"Findings from the breadth pass, kept separate from the structural claims.","findings":[{"id":"evidence-confidence-notes","name":"Check these first","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these check these first hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-confidence-notes-q01","kind":"provenance"}]},{"id":"evidence-identifiers","name":"Identifiers and schemes","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these identifiers and schemes hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-identifiers-q01","kind":"provenance"}]},{"id":"evidence-real-world-use","name":"Real-world use","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these real-world use hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-real-world-use-q01","kind":"provenance"}]},{"id":"evidence-measurements","name":"Typical measurements","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these typical measurements hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-measurements-q01","kind":"provenance"}]},{"id":"evidence-failure-modes-and-hazards","name":"Failure modes and hazards","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these failure modes and hazards hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-failure-modes-and-hazards-q01","kind":"provenance"}]},{"id":"evidence-regional-variation","name":"Regional variation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these regional variation hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-regional-variation-q01","kind":"provenance"}]},{"id":"evidence-neighbours","name":"Neighbouring kinds and how to tell them apart","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these neighbouring kinds and how to tell them apart hold for the sense of fotemustine this model covers, and on what evidence?","id":"evidence-neighbours-q01","kind":"provenance"}]}]}]}]},"agentConduct":{"may":["Explain what fotemustine is used for, citing approved product information where it is authorized.","Report documented warnings from official labels."],"mustNot":["Prescribe, prepare or adjust doses of fotemustine.","Advise handling cytotoxic drugs outside controlled pharmacy procedures.","Present it as a cure or as effective for unapproved uses.","Share a patient's diagnosis or treatment without consent."],"requiresHuman":["Any treatment decision, made by the patient's oncologist.","Handling spills or disposal of cytotoxic waste."]},"ethics":{"considerations":["Cancer patients face hard choices; honest information about benefit and harm matters.","Staff who prepare cytotoxic drugs are exposed to occupational risk."],"affectedParties":["Patients with cancer","Pharmacy and nursing staff","Families"]},"owners":{"steward":"The marketing authorization holder; the treating oncologist for each patient.","roles":[],"masterSystems":["Medicines regulator product registers"]},"relations":[{"target":"Q11173","type":"parent","note":"registry parent class"}],"interaction":{"identity":{"applicability":"required","items":["Vercy registry: vr.tr.fotemustine","Wikidata: Q1439555 (https://www.wikidata.org/wiki/Q1439555)"]},"properties":{"applicability":"required","items":["Molecular identity: Structure identifier and stereochemical specification; reference PubChem CID 104799","Identifier correspondence: Registry id linked to CAS, EC and supplier identifiers, with source and identity scope","Fotemustine assay: % mass fraction or mg/g, with as-is or corrected basis and analytical method","Impurity profile: Individual and total impurities in % or mg/g; identities, method and reporting limits","Material grade: Reference standard, research material, pharmaceutical starting material or unspecified; supporting specification","Physical state: Observed phase and appearance at recorded temperature, pressure and composition","Solubility: mg/mL or mol/L, with solvent, temperature, pH where relevant and equilibration time","Solution concentration: mg/mL or mmol/L of intact fotemustine, with solvent and elapsed time","Stability status: Supported within conditions, excursion under assessment, degraded or unknown","Biological activity class: Alkylating agent; nitrosourea","Applicable hazard classification: Source-specific classification, jurisdiction, revision date and substance or mixture scope"]},"recognition":{"applicability":"required","items":["Supplied as a powder for reconstitution with a solvent, in labelled vials.","Cytotoxic warning labels identify packaging; identity is settled by the label."]},"capabilities":{"applicability":"required","items":["Reconcile a candidate substance record with fotemustine using structure and traceable identifiers.","Compare a sample's assay and impurities against its intended-use specification.","Assess whether storage history and analytical evidence support continued use or quarantine.","Evaluate whether a proposed solvent and holding time have supporting fotemustine stability data.","Retrieve applicable cytotoxic-material handling and disposal requirements.","Link fotemustine to containing products and biological studies while preserving their separate identities."]},"hazards":{"applicability":"required","items":["Can suppress the bone marrow, leading to infections and bleeding.","Exposure through skin contact or spills harms handlers."]},"interfaces":{"applicability":"required","items":["The Anatomical Therapeutic Chemical classification maintained by the WHO Collaborating Centre for Drug Statistics Methodology assigns fotemustine code L01AD05 within the nitrosoureas."]},"context":{"applicability":"required","items":["Fotemustine is encountered in pharmaceutical research, medicine manufacture and specialist oncology settings.","It has been used as an antineoplastic medicine for melanoma and certain primary brain tumours, with clinical use depending on the applicable authorization and treatment context."]}},"sources":[{"title":"Wikidata item Q1439555: fotemustine","url":"https://www.wikidata.org/wiki/Q1439555","note":"identity and sense of the item"},{"title":"Wikipedia: Fotemustine","url":"https://en.wikipedia.org/wiki/Fotemustine","note":"general description of the item"}],"openQuestions":["How should the multiple CAS and other identifiers appearing in aggregated fotemustine records be reconciled, particularly where stereochemical scope may differ?","Which authoritative specification establishes assay, related-substance limits and reference methods for the relevant fotemustine grade?","Which experimentally supported phase, thermal and solubility values are available, and which commonly reported values are predictions or decomposition observations?","What primary stability data establish acceptable storage conditions and solution holding times for each relevant composition and container?","Which current jurisdiction-specific hazard classifications, occupational exposure limits if any, and cytotoxic-waste requirements apply to the intended material and operation?"],"resources":{"spec":"/models/things/publications/thing-q1439555/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q1439555/spec.json"],"providers":["Codex"],"researchStatus":"unreviewed","generatedAt":"2026-09-12T09:52:09Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"filled","ethics":"filled","owners":"filled","relations":"filled","interaction.identity":"filled","interaction.properties":"filled","interaction.recognition":"filled","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"filled"},"notes":{"_gate":"Published through the thing publication gate 1.0 on 2026-10-07T10:10:26+00:00: completeness 1.00; sense: Wikidata description; 2 live sources; review by codex: pass"},"score":1.0}}