6ANALYTICAL ASPECTS FOR DETERMINATION OF MASS BALANCES

Matthew Jorgensen*

Chemical R&D, Pfizer, Inc., Groton, CT, USA

6.1 INTRODUCTION

The role of the analytical chemist in API process development is critically important in the pharmaceutical industry. The analyst and the analytical data they provide are the “eyes” on the process. Without accurate analytical results, the process would be running blind. Often the process engineer and chemist know what to expect. But without reliable analytical data, it is impossible to know if the processes have quantitatively met expectations.

The level of importance placed on the analytical data highlights how critical it is that the data be sound and truly representative of the process.

Occasionally the analytical results may be confounded with unquantified or unseparated components or simply may be nonrepresentative due to oversight on the part of the chemist, engineer, analyst, or a combination of the three. This breakdown in the quality of the analytical results is traced back to a breakdown in the communication between the parties involved. Information that one or all parties are unaware of can directly impact the quality of the analytical results. The entire process team needs to be cognizant of information such as the stability of reaction components, composition of samples (in addition to starting materials intermediates and products), and what level of precision is required of the results.

This chapter will deal directly with what ...

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