Module 3 - Strategic case studies in practice

55

Pharmaceutical Expert Report Form 11

PART II C

CONTROL OF STARTING MATERIALS

II C 2.a: OTHER CONSTITUENTS (ROUTINE TESTS)

COMMENT

(a) Other constituents described ln a pharmacopoeia

Starch EP Croscarmellose Sodium NF Sodium Lauryl Sulphate EP Magnesium Stearate EP

Capsule

Gelatin EP

(b) Other constituents not described ln a pharmacopoeia

Titanium Dioxide Erythrosine Quinoline Yellow

These are the capsule colourants and identity tests are provided in the licence documentation.

t .