Module 3 - Strategic case studies in practice

3.2.P.5

Control of Drug Product – Max Strength Cold & Flu Day & Night Capsules

3.2.P.5.1

Specification The Drug Product Specification is provided below:

Day Capsules:

Acceptance Limits

Test

Method

Release

End of Shelf Life

Off white powder, free from large aggregates and particulate contamination. Odourless. Capsule with Yellow body and Red cap. Size 0.

Appearance and Odour of Powder

As Release

DAM 001

Appearance of Capsule

DAM 001

As Release

No discolouration or product/pack interaction.

Appearance of Packaging Average Fill Weight (g) Uniformity of Weight Paracetamol (mg/capsule) Paracetamol Identification

DAM 001 DAM 003 DAM 118 or DM 140 DAM 013

N/A

0.566 – 0.602

As Release

Ph.Eur (Capsules)

Ph.Eur

N/A

475 – 525

As Release

Complies by HPLC

N/A

Phenylephrine HCl (mg/capsule) DAM 118 or DM 140

5.8 – 6.4

As Release

Phenylephrine HCl Identification Phenylephrine HCl Content Uniformity

DAM 013

Complies by HPLC

N/A

Ph.Eur & DAM 118 or DM 140 DAM 118 or DM 140

Ph.Eur (Test B) 

N/A

Caffeine (mg/capsule) Caffeine Identification

23.75 – 26.25

As Release

DAM 013

Complies by HPLC

N/A

All capsules disintegrate within 7.5 minutes

Disintegration

Ph.Eur

As Release

Microbiological Quality of Pharmaceutical Preparations

Ph.Eur

Ph.Eur 

Ph.Eur

Related Substances 4-Aminophenol

Not more than 0.1% with respect to Paracetamol. Not more than 0.005% with respect to Paracetamol No unidentified Related Substance more than 0.2% and total Related Substances not more than 0.5% with respect to Paracetamol No single degradant more than 0.5% with respect to Phenylephrine HCl No unidentified Related Substance more than 0.5% and total Related Substances not more than 1.0% with respect to Phenylephrine HCl No unidentified Related Substance more than 0.5% and total Related Substances not more than 1.0% with respect to Caffeine

DAM 098

N/A

4’-Chloroacetanilide

DAM 098

N/A

Paracetamol Related Substances

DAM 098

N/A

Phenylephrine HCl Degradation Products (Isoquinoline 6 and Isoquinoline 8)

DAM 100

N/A

Phenylephrine HCl Related Substances

DAM 100

N/A

DAM 118 or DM140

Caffeine Related Substances

N/A

 1 in 10 batches will be tested at release with a minimum of 1 batch per year.  Would comply if tested