Module 3 2019

Target Product Profile – TOPRAnib example

Quality Attribute

Target

Criticality

Dosage form

Tablet, maximum weight 250 mg

Not applicable

Potency

50 mg

Not applicable

Pharmacokinetics

Immediate release enabling T max

in <3 hours

Related to dissolution

Appearance

Tablet conforming to description (shape and size)

Critical

Identity

Positive for TOPRAnib

Critical

Assay

95 – 105%

Critical

Impurities

Impurity A NMT 0.4% Other impurities NMT 0.2% Total NMT 1.0%

Critical

Water

NMT 2%

Not critical – API not moisture sensitive

Content Uniformity Meets Ph.Eur.

Critical

Hardness

6-10 kP

Not critical – related to dissolution

Friability

NMT 1.0%

Not critical

Dissolution

Consistent with immediate release For example: very rapid (> 85 % within 15 min) or rapid (85 % within 30 min)

Critical

Disintegration

NMT 15 mins

Not critical – precursor to dissolution

Microbiology

If tested meets Ph. Eur. criteria

Not critical – drug product does not support microbial growth

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