ICH Q1 Stability Testing of New Drug Substances and Products
E555140
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| ICH Q1 Stability Testing of New Drug Substances and Products canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5932232 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH Q1 Stability Testing of New Drug Substances and Products Context triple: [ICH, notableGuideline, ICH Q1 Stability Testing of New Drug Substances and Products]
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A.
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.
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B.
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.
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C.
Certificates of Suitability to the monographs of the European Pharmacopoeia
Certificates of Suitability to the monographs of the European Pharmacopoeia are official documents issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) confirming that a substance’s quality complies with the relevant European Pharmacopoeia monograph, thereby simplifying regulatory approval for medicines across Europe.
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D.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
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E.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
- 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 Q1 Stability Testing of New Drug Substances and Products Target entity description: 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.
-
A.
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.
-
B.
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.
-
C.
Certificates of Suitability to the monographs of the European Pharmacopoeia
Certificates of Suitability to the monographs of the European Pharmacopoeia are official documents issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) confirming that a substance’s quality complies with the relevant European Pharmacopoeia monograph, thereby simplifying regulatory approval for medicines across Europe.
-
D.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
-
E.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmaceutical stability guideline ⓘ regulatory guideline ⓘ |
| abbreviatedAs | ICH Q1 NERFINISHED ⓘ |
| aimsTo |
ensure quality of pharmaceutical products over shelf life
ⓘ
harmonise stability testing requirements among ICH regions ⓘ support assignment of expiration dates for drug products ⓘ support assignment of retest periods for drug substances ⓘ |
| appliesIn |
European Union
NERFINISHED
ⓘ
Japan NERFINISHED ⓘ United States NERFINISHED ⓘ |
| appliesTo |
marketed pharmaceutical products with significant changes
ⓘ
new chemical entities ⓘ new drug products ⓘ |
| covers |
evaluation and extrapolation of stability data
ⓘ
relative humidity conditions for stability studies ⓘ requirements for stability testing after packaging changes ⓘ temperature conditions for stability studies ⓘ |
| defines |
requirements for accelerated stability studies
ⓘ
requirements for intermediate stability studies ⓘ requirements for long-term stability studies ⓘ requirements for shelf life estimation ⓘ requirements for stability study design ⓘ requirements for stability testing of drug products in proposed container-closure systems ⓘ requirements for stability-indicating analytical methods ⓘ requirements for storage condition assignment ⓘ requirements for stress testing of drug substances ⓘ requirements for testing frequency in stability studies ⓘ |
| hasPart |
ICH Q1A(R2)
NERFINISHED
ⓘ
ICH Q1B NERFINISHED ⓘ ICH Q1C NERFINISHED ⓘ ICH Q1D NERFINISHED ⓘ ICH Q1E NERFINISHED ⓘ ICH Q1F NERFINISHED ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| language | English ⓘ |
| regulates |
stability testing of new drug products
ⓘ
stability testing of new drug substances ⓘ |
| relatedTo |
Good Manufacturing Practice
NERFINISHED
ⓘ
pharmaceutical quality by design ⓘ |
| subjectOf |
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
NERFINISHED
ⓘ
ICH Q1B: Photostability Testing of New Drug Substances and Products NERFINISHED ⓘ ICH Q1C: Stability Testing for New Dosage Forms NERFINISHED ⓘ ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products NERFINISHED ⓘ ICH Q1E: Evaluation of Stability Data NERFINISHED ⓘ ICH Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV NERFINISHED ⓘ |
| usedBy |
pharmaceutical companies
ⓘ
regulatory authorities in ICH regions ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: ICH Q1 Stability Testing of New Drug Substances and Products Description of subject: 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.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.