Module 3 - Strategic case studies in practice

Night Capsules:

Acceptance Limits

Test

Method

Release

End of Shelf Life

Off white powder, free from large aggregates and particulate contamination. Odourless. Capsule with translucent light blue body and dark blue 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)

DAM 001 DAM 003 DAM 118L or DM 141 DAM 013

N/A

0.542 – 0.576

As Release

Uniformity of Weight

Ph.Eur (Capsules)

Ph.Eur

N/A

Paracetamol (mg/capsule) Paracetamol Identification

475 – 525

As Release

Complies by HPLC

N/A

Phenylephrine HCl (mg/capsule) DAM 118L or DM 141

5.8 – 6.4

As Release

Phenylephrine HCl Identification Phenylephrine HCl Content Uniformity

DAM 013

Complies by HPLC

N/A

Ph.Eur & DAM 118L or DM 141

Ph.Eur (Test B) 

N/A

All capsules disintegrate within 15 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

Not Required [Would comply if tested] Not Required [Would comply if tested]

DAM 098

4’-Chloroacetanilide

DAM 098

Paracetamol Related Substances

Not Required [Would comply if tested]

DAM 098

Phenylephrine HCl Degradation Products (Isoquinoline 6 and Isoquinoline 8)

Not Required [Would comply if tested]

DAM 100

Phenylephrine HCl Related Substances

Not Required [Would comply if tested]

DAM 100

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

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