Dr. Joan Malmstrøm

Principal Scientist
Novo Nordisk
Copenhagen, Denmark

Joan Malmstrøm is a Principal Scientist at Novo Nordisk A/S holding a Ph.D. degree in chemistry from the University of Copenhagen and +20 years of experience with structural elucidation of organic molecules using nuclear magnetic resonance spectroscopy and mass spectrometry as analytical tools.

The projects she has been involved in at Novo Nordisk A/S ranges from small molecules (API’s, raw materials/excipients, etc.) up to peptides/proteins and large molecular weight polymers.

During the past years one of her main activities has been the development of analytical methods suitable for analysis of leaching of silicone oil and degradation products hereof into the aqueous phase kept in primary packing material.

Related Sessions:

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Pre-Filled Syringes
Summit 2018

Enhance a fully integrated system approach for developing pre-filled syringes to maintain patient centricity.

31 May 2018
Berlin, DE
Pharma

Day 2: Friday, 01 June 2018

BLOCK: COMPONENT SELECTION AND PRIMARY PACKAGING.

CASE STUDY: Application of Quantitative 1H-NMR Spectroscopy for the determination of silicone oil and degradation products hereof.

Non destructive detection of silicone oil and it’s degradation products.
Detection of solvent residues and precipitation.
Linear quantitative method working in aqueous as well as organic solvents.
Simple to validate according to ICH principles.
Stability indicating method.
Orthogonal method to e.g. MFI and ICP.
Applicable to many other subjects where silicone oil is of interest, e.g. the use of anti-foaming silicone agents.

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Dr. Joan Malmstrøm