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Question 1/10
Does the particle show an extreme
aspect ratio, or is it very small?
Yes
No
Don't know
Somewhat
?
N/A
Question 2/10
Is the powder flow poor?
Yes
No
Don't know
Somewhat
?
If the flow is good or acceptable, then answer “No”
.
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Question 3/10
Is API bulk density low?
Yes
No
Don't know
Somewhat
Question 4/10
Is the API a salt with an acidic counterion?
Yes
No
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Question 5/10
If the API is a salt with an acidic counterion, is the pKa of the API less than 5?
Yes
No
Don't know
Somewhat
Question 5/10
Is the number of salt forms identified
from the salt screen few in number?
Yes
No
Don't know
Somewhat
?
If response is Yes it means that many salts identified from screen or parent molecule have no acidic or basic groups
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Question 6/10
Following detailed polymorph studies, have a large number of polymorphs solvates and hydrates been found?
Yes
No
Don't know
Somewhat
Question 7/10
Does the computational informatics
assessment of the API suggest that
a more stable polymorph, hydrate or process
relevant solvate can exist?
Yes
No
Don't know
Somewhat
?
N/A
.
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Question 8/10
Is the API hygroscopic?
Yes
No
Don't know
Somewhat
?
If your API picks up significant water, then it is hygroscopic. If “No”, it means that the selected version does not pick-up significant water.
Question 9/10
Is the melting point of the API low?
Yes
No
Don't know
Somewhat
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Question 10/10
Does the API require size reduction?
Yes
No
Question 11/11
If the API requires size reduction,
is there evidence of amorphisation?
Yes
No
Don't know
Somewhat
?
Amorphisation refers to a limited or amorphous content that is not measurable.
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