Triple
T22456998
| Position | Surface form | Disambiguated ID | Type / Status |
|---|---|---|---|
| Subject | ICH Q3A Impurities in New Drug Substances |
E555141
|
entity |
| Predicate | relatedGuideline |
P148273
|
FINISHED |
| Object | ICH Q3B Impurities in New Drug Products |
—
|
NE NERFINISHED |
How this triple was built (4 steps)
Every LLM step that produced this triple, in pipeline order — named-entity classification, the disambiguation choices (the exact options shown, with the pick highlighted), and the generated description. The batch + timestamp of each is in the Provenance table below.
NER
Named-entity recognition
gpt-5-mini
Instruction
Given a phrase, classify it is english named entity (e.g., persons, organizations, works of art) in Latin script, or not (e.g., literals, dates, URLs, verbose phrases). For disambiguation, the statement where the phrase occurs as object is also given. Please return a JSON object with `phrase` (string, the phrase being analyzed) and `is_ne` (boolean, indicating whether the phrase is a Named Entity).
Input
Phrase: ICH Q3B Impurities in New Drug Products | Statement: [ICH Q3A Impurities in New Drug Substances, relatedGuideline, ICH Q3B Impurities in New Drug Products]
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH Q3B Impurities in New Drug Products Context triple: [ICH Q3A Impurities in New Drug Substances, relatedGuideline, ICH Q3B Impurities in New Drug Products]
-
A.
ICH Q3A Impurities in New Drug Substances
ICH Q3A Impurities in New Drug Substances is an international regulatory guideline that sets quality standards and thresholds for identifying, reporting, and controlling impurities in new active pharmaceutical ingredients.
-
B.
ICH Q11 Development and Manufacture of Drug Substances
ICH Q11 Development and Manufacture of Drug Substances is an ICH guideline that provides principles and expectations for the development and manufacturing of chemical and biotechnological drug substances within a quality-by-design framework.
-
C.
ICH Q1 Stability Testing of New Drug Substances and Products
ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
-
D.
ICH Q8 Pharmaceutical Development
ICH Q8 Pharmaceutical Development is an international guideline that outlines a systematic, science- and risk-based approach to pharmaceutical product and process development, forming a core part of the ICH quality framework.
-
E.
ICH Q10 Pharmaceutical Quality System
ICH Q10 Pharmaceutical Quality System is an international guideline that establishes a comprehensive, lifecycle-based framework for pharmaceutical quality management to ensure consistent product quality and regulatory compliance.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: ICH Q3B Impurities in New Drug Products Target entity description: ICH Q3B Impurities in New Drug Products is an ICH quality guideline that sets thresholds and requirements for identifying, reporting, and qualifying impurities present in finished pharmaceutical products.
-
A.
ICH Q3A Impurities in New Drug Substances
ICH Q3A Impurities in New Drug Substances is an international regulatory guideline that sets quality standards and thresholds for identifying, reporting, and controlling impurities in new active pharmaceutical ingredients.
-
B.
ICH Q11 Development and Manufacture of Drug Substances
ICH Q11 Development and Manufacture of Drug Substances is an ICH guideline that provides principles and expectations for the development and manufacturing of chemical and biotechnological drug substances within a quality-by-design framework.
-
C.
ICH Q1 Stability Testing of New Drug Substances and Products
ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
-
D.
ICH Q8 Pharmaceutical Development
ICH Q8 Pharmaceutical Development is an international guideline that outlines a systematic, science- and risk-based approach to pharmaceutical product and process development, forming a core part of the ICH quality framework.
-
E.
ICH Q10 Pharmaceutical Quality System
ICH Q10 Pharmaceutical Quality System is an international guideline that establishes a comprehensive, lifecycle-based framework for pharmaceutical quality management to ensure consistent product quality and regulatory compliance.
- F. None of above. chosen
PD
Predicate disambiguation
gpt-5-mini-2025-08-07
Target predicate: relatedGuideline Context triple: [ICH Q3A Impurities in New Drug Substances, relatedGuideline, ICH Q3B Impurities in New Drug Products]
-
A.
notableGuideline
Indicates that something is recognized as an important or especially significant rule, principle, or recommended practice.
-
B.
hasGuideline
Indicates that one entity is governed, informed, or constrained by a rule, standard, or recommended procedure provided by another entity.
-
C.
usesGuidelines
Indicates that one entity follows or applies a specified set of guidelines in performing an action or making decisions.
-
D.
guidelineNumber
Indicates the specific numeric identifier assigned to a guideline within a set of rules, standards, or recommendations.
-
E.
relatedRule
Indicates that one rule is connected or associated with another rule, typically through some logical, structural, or referential relationship.
- F. None of above. chosen
Provenance (4 batches)
The batch behind each pipeline step, in order, with when it ran. Timestamps are batch-level — stages were processed in waves, so the object chain (NER → NED1 → NEDg → NED2) reads in order, but predicate / elicitation batches can sit in a different wave.
| Step | Stage | Batch ID | Status | When |
|---|---|---|---|---|
| creating | Elicitation | batch_69e11e51fdec8190adfdf9f8a6362221 |
completed | April 16, 2026, 5:37 p.m. |
| NER | Named-entity recognition | batch_69f15b7c428c8190847a259eef969525 |
completed | April 29, 2026, 1:14 a.m. |
| PD | Predicate disambiguation | batch_69e898ad961c819098fd1e46129bddcc |
completed | April 22, 2026, 9:45 a.m. |
| PDg | Predicate description generation | batch_69e8aa39e3388190b659d59948ebf3e6 |
completed | April 22, 2026, 11 a.m. |
Created at: April 16, 2026, 8:48 p.m.