Spring Intro 2023

28/03/2023

3.2.P.5 Control of Drug Product Typical Tablet FP Specification

Test

Specification

Method

Appearance

Complies with reference standard Complies with reference standard

Visual

Identity

IR (Ph. Eur.) HPLC retention time

Assay

95-105% at release 91-105% shelf life

HPLC (in-house)

Dissolution

NLT 70% (Q) dissolved in 30 minutes

Type I Apparatus Ph. Eur. UV Spectrophotometer

Moisture Content

NMT 3%

KF (Ph. Eur.)

Uniformity of Dosage Units

Ph. Eur. criteria

HPLC (in-house)

Degradation Impurities

NMT 4% Total NMT 0.5% Individual

HPLC (in-house)

Microbial Quality

Ph. Eur. criteria

Ph. Eur. test methods

The Organisation for Professionals in Regulatory Affairs

NLT – Not Less Than; NMT – Not More Than; KF – Karl Fischer Method

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3.2.P Drug Product 3.2.P.5 Control of Drug Product

• Specifications should include individual specified and unspecified and total impurities (Time of Release and End of Shelf Life) • Current specifications cannot be reasonably derived from the available time of release and shelf-life testing of the API. • In the EU, “Ideal” potency limits are 95 – 105% (for small molecule drugs) unless batch data justifies wider limits (US “Ideal” is 90 – 110%) • Unspecified impurities limit should be NMT 0.2% or 0.10% depending on the maximum daily dose • Specified Ph. Eur. impurities limits should be consistent with Ph. Eur. • Drug product specifications and test methods should be consistent with the registered drug substance specifications

The Organisation for Professionals in Regulatory Affairs

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