Assertion: impurity | /r/HasProperty | below the m7(r1limit by at least 30%
Facets:
value: by at least 30%
type: OTHER
value: consistently
type: MANNER
Source sentences:
text: Include a suitable method for known PGIs among the release tests for each starting material, intermediate, or reagent with an acceptance criterion above the acceptable limit specified under M7(R1), coupled with a demonstrated understanding of downstream fate and purging and associated process controls in lab studies assure that no further testing is needed to confirm that the impurity is consistently below the M7(R1) limit by at least 30%.