Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Impurities

Details about impurity identification and characterization.

Product

Resources

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

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.P.5 Control of Drug Product
  • 3.2.P.5.5 Characterisation of Impurities

XML and JSON examples of synthetic CTD data:

• Product Impurities example XML
• Product Impurities example JSON

HTML presentation example of synthetic CTD data:

• Product Impurities example HTML

Substance

Resources

SubstanceDefinition	The substance itself and its impurities as substances
DocumentReference	Image files e.g. for molecular structure

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.S.3 Characterisation
  • 3.2.S.3.2 Impurities

XML and JSON examples of synthetic CTD data:

• Substance Impurities example XML
• Substance Impurities example JSON

HTML presentation example of synthetic CTD data:

• Substance Impurities example HTML

Profiles

See Artifacts Index: Impurities