Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | Computable Name: PqcmcExcipientFunctionTerminology | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.11 | ||||
Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
References
Generated Narrative: ValueSet pqcmc-excipient-function-terminology
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl| Code | Display |
| C176637 | Absorption modifier |
| C89528 | Adhesive |
| C176642 | Adsorbent |
| C176643 | Air displacement |
| C275 | Antioxidant |
| C42647 | Binder |
| C70815 | Buffering agent |
| C176644 | Bulking agent |
| C176645 | Carrier |
| C360 | Chelating agent |
| C42656 | Coloring agent |
| C176646 | Complexing agent |
| C53306 | Cryoprotectant |
| C176647 | Denaturant |
| C42648 | Disintegrant |
| C42662 | Dispersing agent |
| C927 | Vehicle |
| C176638 | Effervescent agent |
| C176632 | Emollient |
| C73477 | Emulsifying Excipient |
| C176633 | Emulsion stabilizing agent |
| C42650 | Filler |
| C176648 | Film coating agent |
| C176634 | Foam stabilizing agent |
| C176649 | Free radical scavenger |
| C176650 | Gelling agent |
| C42654 | Anticaking agent |
| C176651 | Humectant |
| C42653 | Lubricant |
| C176652 | Lyophilization aid |
| C176653 | Matrix-forming agent |
| C176654 | Microencapsulating agent |
| C176655 | Ointment base |
| C176656 | Opacifier |
| C176660 | Polymers for ophthalmic use |
| C176635 | Organoleptic agent |
| C176657 | Osmotic agent |
| C55826 | Plasticizer |
| C176659 | Polishing agent |
| C42659 | Preservative |
| C42657 | Ink |
| C176661 | Propellant |
| C176639 | Reducing agent |
| C176662 | Release modifying agent |
| C176640 | Solubilizing agent |
| C45790 | Solvent |
| C176636 | Stabilizer |
| C176663 | Suppository base |
| C42739 | Surfactant |
| C42660 | Suspending agent |
| C176641 | Tonicity agent |
| C176664 | Transdermal delivery component |
| C176665 | Transfer ligand |
| C176666 | Viscosity modifier |
| C176667 | Water-repelling agent |
| C176668 | Wetting agent |
| C176658 | pH modifier |
Generated Narrative: ValueSet
Expansion based on supplement PQ-CMC-FDA NCIt Hieararchy Supplement v2.0.0-ballot (CodeSystem)
This value set contains 57 concepts
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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