Module 3 - Strategic case studies in practice

Proposed Finished Product Specification – PL 12063/0003 Cold Relief Capsules

Acceptance Limits

Test

Release

Shelf-Life

Green capped, yellow body size 1 capsule containing a white flowing powder Essentially odourless; no foreign odour should be present Not more than two capsules deviate by more than ±7.5% from the average and none deviate more than ± 15% from the average

Appearance

As release

Odour

As release

Uniformity of Weight (capsule content) (20 capsules) Average net weight (mg) Disintegration Time Identities a) Paracetamol b) Caffeine c) Phenylephrine HCL Assays a) Paracetamol (mg/cap) b) Caffeine (mg/cap) c) Phenylephrine HCL (mg/cap) Uniformity of Content Phenylephrine HCl (carried out on 10 capsules)

As release

332 – 362

As release

30 minutes maximum

As release

Positive Positive Positive

As release

285 – 315 23.75 – 26.25 4.75 – 5.25

As release

Not more than one of the individual values is outside the range 4.25 – 5.75 and none are outside the range 3.75 – 6.25. If these criteria are not met consult the BP* Not more than 0.1% with respect to Paracetamol

Ph.Eur *

4-Aminophenol

N/A

*Would comply if tested.