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Details about impurity identification and characterization.
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| MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg) |
| SubstanceDefinition | The documented impurities |
| 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 |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation example of synthetic quality data:
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| SubstanceDefinition | The substance itself and its impurities as substances |
| DocumentReference | Image files e.g. for molecular structure |
CTD section synthetic source data samples (PDF):
XML and JSON examples of synthetic quality data:
HTML presentation example of synthetic quality data: