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Details about impurity identification and characterization.
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MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg) |
SubstanceDefinition | The documented impurites |
Medication | Describes the batches of the product that underwent testing for impurities |
Observation | The results of testing for impurities in the batches |
Organization | The company/site that performed the testing, or manufactured the batch |
DiagnosticReport | Contains all results as a group, with conclusions |
eCTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic CTD data:
HTML presentation example of synthetic CTD data:
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SubstanceDefinition | The substance itself and its impurities as substances |
DocumentReference | Image files e.g. for molecular structure |
eCTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic CTD data:
HTML presentation example of synthetic CTD data: