niraparib
Enable an agent to identify niraparib, assess the identity and fitness of a material containing it, and determine which handling or use decisions require additional evidence.
Bundle → Layer → Finding → Questions Filled
6 bundles · 11 layers · 19 findings · 37 questions
Niraparib identity Establish the molecular entity represented by the registry entry and distinguish related material identities.
Parent structure
Record connectivity, stereochemistry, and parent-specific identifiers.
Stereochemical identity
Require a structural match that includes the specified stereocentre; an elemental formula alone is insufficient.
- Which stereochemical structure defines niraparib in this registry entry? definition
- Which reference and analytical evidence establish that the sample has the required stereochemistry? provenance
Related material identities
Relate salts and hydrates to the niraparib parent without silently equating their compositions.
Salt and hydrate boundary
Attach counterion, stoichiometry, and hydration evidence to the material description while retaining the parent-substance relationship.
- Does the record describe neutral niraparib, niraparib tosylate monohydrate, or another explicitly identified form? boundary
- Which identifiers belong to that form rather than to the niraparib parent? definition
- What evidence establishes the counterion ratio and hydration state? measurement
Niraparib composition and quality Describe how much verified niraparib a sample contains and whether its accompanying constituents are acceptable.
Content basis
Make niraparib quantity interpretable across parent, salt, hydrated material, and solution.
Active-moiety accounting
Record whether reported content refers to niraparib equivalents or total salt material and preserve all correction factors.
- Is the reported mass or concentration expressed as niraparib equivalents or as the supplied salt? measurement
- Which measured assay, water content, and verified stoichiometry support conversion between those bases? measurement
Impurities and acceptance
Assess chemical, stereochemical, and volatile constituents against a declared use.
Use-specific quality
Keep chemical assay, chromatographic area purity, and enantiomeric purity distinct when judging a niraparib lot.
- Which methods quantify niraparib, the undesired enantiomer, related impurities, and residual solvents? measurement
- Which specification and reference-standard records justify accepting this lot for the intended use? provenance
- Which failed or missing results require quarantine or further analysis? action
Niraparib physical state and stability Connect material form and environmental conditions to measured physical behaviour and retained quality.
Solid and solution behaviour
Distinguish solid-state identity from behaviour in a specified solvent environment.
Form-conditioned properties
Associate solubility and thermal measurements with the actual salt, hydration state, and experimental conditions.
- What evidence identifies the sample's crystalline, amorphous, hydrated, or dissolved state? measurement
- Under which pH, solvent, temperature, and equilibration conditions was niraparib solubility measured? measurement
- Does a reported thermal event represent melting, dehydration, another transition, or decomposition? boundary
Storage and retest
Evaluate whether storage and preparation history preserve the specified material quality.
Stability-supported disposition
Base storage, solution holding time, and retest decisions on evidence applicable to the material and container.
- Which stability data support the storage conditions and retest interval for this niraparib form? provenance
- Have temperature, humidity, light exposure, or solution-storage conditions exceeded the supported range? measurement
- Which excursion or degradation result requires retesting or rejection? action
Niraparib biological activity Organize evidence about niraparib's interaction with PARP and its context-dependent cellular effects.
PARP target assays
Separate target-specific measurements and mechanistic endpoints.
Assay-specific potency
Preserve the target, endpoint, and assay conditions behind each reported niraparib activity value.
- Does the experiment measure PARP1 inhibition, PARP2 inhibition, PARP-DNA trapping, or another endpoint? definition
- What concentration-response value, uncertainty, and assay conditions were reported? measurement
- Was the niraparib preparation's identity, purity, and dissolved concentration verified? provenance
Cellular response context
Keep cell-level response evidence attached to its biological system and exposure conditions.
Response transfer limits
Record the conditions needed to interpret a niraparib response without converting laboratory activity into clinical eligibility.
- Which cell system, DNA-repair characteristics, exposure duration, and response endpoint define the observation? measurement
- What evidence supports transferring this result to another experimental system? provenance
- Where must interpretation pass to a tumour, biomarker, or clinical-treatment model? boundary
Niraparib handling and use boundaries Connect material-specific handling evidence and dated medicine records to permissible actions.
Occupational material controls
Assess handling of niraparib powder, solutions, and waste using evidence matched to the supplied material.
Handling evidence
Record applicable safety classification and exposure controls without inventing a universal GHS category or exposure limit.
- Which current safety data sheet covers the exact niraparib form, concentration, and supplier? provenance
- Is there an authoritative exposure limit or documented occupational control band for this material? provenance
- Which containment, spill-response, and waste procedures apply to the planned powder or solution operation? action
Medicine regulatory links
Link the active substance to products while preserving jurisdiction, formulation, and label version.
Product-specific authority
Represent approved uses through dated product records rather than as unrestricted permissions attached to niraparib.
- Which product, formulation, jurisdiction, and effective label version support the proposed therapeutic-use claim? provenance
- Does the evidence concern niraparib as a single active ingredient or within a combination product? boundary
- Which eligibility, dosing, and monitoring decisions must be resolved in the linked medicine and patient-care models? action
Evidence and external alignment What the world already says about this thing, gathered so the model can be checked against it.
Reported evidence
Findings from the breadth pass, kept separate from the structural claims.
Check these first
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these check these first hold for the sense of niraparib this model covers, and on what evidence? provenance
Kinds and varieties
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these kinds and varieties hold for the sense of niraparib this model covers, and on what evidence? provenance
Identifiers and schemes
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these identifiers and schemes hold for the sense of niraparib this model covers, and on what evidence? provenance
Standards and regulation
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these standards and regulation hold for the sense of niraparib this model covers, and on what evidence? provenance
Real-world use
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these real-world use hold for the sense of niraparib this model covers, and on what evidence? provenance
Typical measurements
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these typical measurements hold for the sense of niraparib this model covers, and on what evidence? provenance
Failure modes and hazards
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these failure modes and hazards hold for the sense of niraparib this model covers, and on what evidence? provenance
Regional variation
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these regional variation hold for the sense of niraparib this model covers, and on what evidence? provenance
Neighbouring kinds and how to tell them apart
Recalled without web access and unsourced; every item is a lead to verify.
- Which of these neighbouring kinds and how to tell them apart hold for the sense of niraparib this model covers, and on what evidence? provenance
Classifiers Filled
- Family
- Thing Registry
- Category
- Physical world and living systems
- Entry kind
- thing
- Plane
- PHY
- Domain
- PHY.MAT
What it is Filled
Niraparib is a small-molecule inhibitor of poly(ADP-ribose) polymerase enzymes PARP1 and PARP2 used as an oral anticancer drug, particularly in maintenance treatment of selected ovarian, fallopian-tube and primary peritoneal cancers.
In scope
- Molecular identity, stereochemistry, and identifiers for niraparib
- Explicit relationships between the parent substance, salts, hydrates, and physical forms
- Sample composition, purity, analytical identity, and stability
- Evidence describing PARP inhibition and its experimental conditions
- Substance handling constraints and links to product-specific regulatory evidence
Out of scope
- Finished medicine formulations, packaging, and commercial inventory
- Patient-specific prescribing, dosing, and treatment monitoring
- Cancer classification and individual tumour biomarker interpretation
- Manufacturing process design and synthesis execution
- Independent models of other PARP inhibitors or combination-product ingredients
Why it exists Filled
Enable an agent to identify niraparib, assess the identity and fitness of a material containing it, and determine which handling or use decisions require additional evidence.
Distinguishing features Filled
- Match molecular connectivity and the S-configured stereocentre, rather than accepting any PARP inhibitor or a matching molecular formula as niraparib. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib)
- For the neutral parent, check C19H20N4O, CAS 1038915-60-4, and PubChem CID 24958200 against structural evidence. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib)
- Distinguish the parent substance from niraparib tosylate monohydrate, which has its own composition and PubChem CID 74763937. [PubChem salt record](https://pubchem.ncbi.nlm.nih.gov/compound/Niraparib-tosylate-monohydrate)
- Distinguish a niraparib substance sample from a ZEJULA tablet: a product name does not establish the purity or composition of isolated active material. [FDA label](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf)
What robots and AI may and may not do Filled
Must not
- Recommend, dose or adjust niraparib for a specific person.
- Advise obtaining cancer medicines without a prescription or from unverified sellers.
- Present it as a cure or as effective in cancers outside its approved uses without evidence.
- Handle cytotoxic medicines without the precautions their label requires.
Only with a human decision
- Starting, stopping or changing cancer treatment for a patient.
May
- Explain niraparib as a PARP inhibitor used in maintenance treatment of certain cancers, citing official labelling.
- Report approved indications and warnings from the label.
Moral aspects Filled
- Patients with cancer are vulnerable to false hope and counterfeit drugs.
- Genetic testing that guides PARP inhibitor use raises privacy questions.
Who is affected
- Patients with ovarian and related cancers
- Families sharing genetic risk
- Prescribers and pharmacists
Owners Filled
Steward
The prescriber and the pharmacist for each patient; medicines regulators authorize products.
Master systems
- National medicines registers
Links to other meta-models Filled
parent
- Q11173 - registry parent class
What else AI and robots need to interact with it Filled
Identity and identifiers required Filled
- Vercy registry: vr.tr.niraparib
- Wikidata: Q25326660 (https://www.wikidata.org/wiki/Q25326660)
Direct properties required Filled
- Chemical identity: Verified stereochemical structure; parent-specific CAS and PubChem identifiers
- Material form: Neutral parent, specified salt, specified hydrate or solvate; crystalline, amorphous, dissolved, or unresolved
- Niraparib content: Mass fraction or mg/mL, with free-base-equivalent versus salt basis and dry versus as-is basis
- Chemical and stereochemical purity: Assay %, impurity %, and enantiomeric purity or excess %, each with method and reporting basis
- Water and residual solvent content: % w/w water; ppm or % w/w identified solvent
- Condition-dependent physical properties: Solubility in mg/mL with solvent, pH, and temperature; thermal events in °C with method and material form
- PARP activity evidence: PARP1 or PARP2 inhibition endpoint in nM or other reported units, linked to assay conditions
- Sample disposition: Unverified, quarantined, accepted for specified use, rejected, or awaiting retest
- Regulatory and product linkage: Named product or substance record, jurisdiction, document version, and effective date
Recognition required Filled
- Identified by product label, active ingredient name and pack details rather than by appearance alone.
Capabilities and actions required Filled
- Resolve a named sample to the niraparib parent identity and its explicitly documented material form.
- Calculate niraparib-equivalent quantities when salt stoichiometry, hydration, and assay basis are verified.
- Compare a sample's analytical evidence against requirements for a stated research or manufacturing use.
- Select suitable storage and handling controls from evidence applicable to the actual material.
- Compare PARP activity measurements while preserving assay and biological context.
- Route therapeutic-use questions to the applicable medicine and clinical models with dated source links.
Hazards and failure modes required Filled
- Low blood counts and bleeding.
- Raised blood pressure.
- Counterfeit or diverted supply.
Standards and interfaces required Filled
- The Anatomical Therapeutic Chemical classification, maintained by the WHO Collaborating Centre for Drug Statistics Methodology, classifies niraparib among PARP inhibitors.
- The Federal Food, Drug, and Cosmetic Act, enacted by the United States Congress and administered by the Food and Drug Administration, governs niraparib medicines marketed in the United States.
Context of use required Filled
- Niraparib is encountered as an active pharmaceutical ingredient, an analytical reference material and an ingredient in oral anticancer medicines.
- Its clinical role includes maintenance treatment in selected ovarian, fallopian tube and primary peritoneal cancers under jurisdiction-specific authorization.
- Material assessment requires distinguishing the chemical form and purity of the ingredient from the composition and quality of a finished medicine.
Sources Filled
- Wikidata item Q25326660: niraparib - identity and sense of the item
- Wikipedia: Niraparib - general description of the item
Open questions
- Does the existing Vercy catalogue already contain a canonical niraparib model, and how does it represent the parent substance versus salt and hydrate forms?
- Which authoritative specifications establish impurity limits, stereochemical acceptance criteria, and validated analytical methods for each intended material grade?
- Which measured solubility, thermal, solid-state, and stability data apply specifically to the neutral parent and to each supplied salt or hydrate?
- Which current material-specific safety classifications, EC identifiers where applicable, and occupational exposure limits or control bands can be substantiated?
- Which primary assay studies and current jurisdiction-specific product records are needed to support biological activity and therapeutic-use links?
Machine files
Provenance
thing registry research (pass 2) · unreviewed
Built from: models/things/publications/thing-q25326660/spec.json