Source material shall capture information on the taxonomic and anatomical origins as well as the fraction of a material that can result in or can be modified to form a substance.
This set of data elements shall be used to define polymer substances isolated from biological matrices.
Taxonomic and anatomical origins shall be described using a controlled vocabulary as required.
This information is captured for naturally derived polymers ( .
starch) and structurally diverse substances.
For Organisms belonging to the Kingdom Plantae the Substance level defines the fresh material of a single species or infraspecies,
the Herbal Drug and the Herbal preparation.
For Herbal preparations,
the fraction information will be captured at the Substance information level and additional information for herbal extracts will be captured at the Specified Substance Group 1 information level.
See for further explanation the Substance Class: Structurally Diverse and the herbal annex.
Inherited description: ELEMENTQUALIFIED controls the format of exported XML.
The ELEMENTQUALIFIED specification should be based on the elementFormDefault attribute of the
schema that defines the type.
To maintain compatibility, ELEMENTQUALIFIED will default to 1 (true) for literal format export
and will default to 0 (false) for encoded or encoded12 format export.
These were the values always previously assumed for the elementFormDefault attribute.
NOTE: Direct use of XMLExport method does not support the ELEMENTQUALIFIED. The export must be
done using %XML.Writer or SOAP support.
parameter XMLNAME = SubstanceSourceMaterial;
Inherited description: This parameter provides the default XMLNAME for the class. If it is
empty then the class name will be used to construct a default XML name.
The default XMLNAME is used as the top level tag
when exporting objects and the export context
did not provide an XML container name.
parameter XMLPROJECTION = ELEMENT;
parameter XMLSEQUENCE = 1;
Inherited description: If the XMLSEQUENCE = 1, then the order of the XML elements must match the
order of the class properties. This allows us to deal with XML where the
same field appears multiple times and is distinguished by the order.
parameter XMLTYPE = SubstanceSourceMaterial;
Inherited description: This parameter provides the default XMLTYPE for the class. If it is
empty then the class name will be used to construct a default XML type.
The default XMLTYPE is used when naming and referencing this type
in a schema and the schema context did not provide an XML type name.
The country where the plant material is harvested or the countries where the plasma is sourced from as laid down in accordance with the Plasma Master File.
For ?Plasma-derived substances? the attribute country of origin provides information about the countries used for the manufacturing of the Cryopoor plama or Crioprecipitate.
Many complex materials are fractions of parts of plants,
Fraction elements are often necessary to define both Substances and Specified Group 1 Substances.
For substances derived from Plants,
fraction information will be captured at the Substance information level ( .
Juices and Exudates).
Additional information for Extracts,
such as extraction solvent composition,
will be captured at the Specified Substance Group 1 information level.
For plasma-derived products fraction information will be captured at the Substance and the Specified Substance Group 1 levels.
This subclause describes the organism which the substance is derived from.
the parent organism shall be specified based on these subclause elements.
As an example,
full taxonomy will be described for the Substance Name: .,