Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

Night Capsules

mg/ capsule

Reference Standard

Name

Function

ACTIVE INGREDIENT Paracetamol

Ph.Eur & RM/053 Ph.Eur & RM/056

500.0

Analgesic

Phenylephrine Hydrochloride

6.1

Decongestant

EXCIPIENTS Maize Starch

Diluent/ Disintegrating Agent Diluent/Disintegrating Agent

9.0

Ph.Eur

Croscarmellose Sodium Sodium Laurilsulfate Magnesium Stearate

29.2

Ph.Eur Ph.Eur Ph.Eur Ph.Eur

5.9 3.0 6.0

Wetting Agent

Lubricant Flow Aid

Talc

TOTAL CAPSULE FILL

559.2

RM 052

CAPSULE SHELL

Gelatin

94.35

Capsule Shell

Ph.Eur

0.012 † 0.366 † 0.274 †

EC *

Erythrosine (E127)

Colorant

Titanium Dioxide (E171)

Colorant/Opacifier

Ph.Eur

EC *

Indigo Carmine (E132)

Colorant

TOTAL CAPSULE SHELL

95

GRAND TOTAL 654.2 † Due to the nature of the raw materials, their sourcing and technology improvements, the colorant composition data indicated are target values. Actual values may vary to ensure consistency of lot colour. * Complies with Commission Directive 95/45/EC which lays down the criteria concerning colours for use in foodstuffs.