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 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

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Extension: Product Batch Strength Textual Extension

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension				Version: 2.0.0
Standards status: Trial-use			Maturity Level: 2	Computable Name: ProductBatchStrengthTextualExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.64

Extension for strength as a string for ingredients in the batch formula.

Context of Use

This extension may be used on the following element(s):

• Element ID: ManufacturedItemDefinition.component.constituent

Usage info

Usage:

• Use this Extension: Drug Product Batch Formula
• Examples for this Extension: Bundle/BatchFormulaBundle

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

 

Other representations of profile: CSV, Excel, Schematron

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()