ABSTRACT

Immunoglobulin Products ................................................ 343 18.4 Conclusion ................................................................................... 350 Keywords .............................................................................................. 351 References ............................................................................................. 351

18.1 INTRODUCTION

Multi-angle laser light scattering detector (MALLS) method was validate for the analyses molecular mass distribution of hydroxylethyl starch and was used for the determination percentage and molecular mass of polymers and aggregates in albumin’s and immunoglobulin’s products obtained from different manufacturers. Calculated percentages of aggregates in albumin products by both European Pharmacopoeia and MALLS methods were compared.