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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
?
Hint
Extreme aspect ratio refers to particles having equant habit and being greater than 30um.
Question 2/10
Is the powder flow poor?
Yes
No
Don't know
Somewhat
?
Hint
If response is No it means that flow is good or acceptable
Next
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
Next
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
?
Hint
If response is Yes it means that many salts identified from screen or parent molecule have no acidic or basic groups
Next
Question 6/10
Have a large number of polymorphs
solvates and hydrates been found
following detailed polymorph studies?
Yes
No
Don't know
Somewhat
Question 7/10
Does the computational Informatics
assessment of the API suggest that
a more polymorph, hydrate or process
relevant solvate can exist?
Yes
No
Don't know
Somewhat
?
Hint
If response is Yes, it means that informatics assessment confirms the most stable form is being developed with limited ability to hydrate or form solvates
Next
Question 8/10
Is the API hygroscopic?
Yes
No
Don't know
Somewhat
?
Hint
If an API is not hygroscopic 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
Next
Question 10/10
Does the API require size reduction?
Yes
No
Question 11
If the API requires size reduction,
is there evidence of amorphization?
Yes
No
Don't know
Somewhat
?
Hint
Amorphisation refers to a limited or amorphous content that is not measurable.
Next
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