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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