Special Test Methods

Especially in laboratories in a regulated environment, tests according to the provisions for the European Pharmacopoeia (Ph.Eur.) are inconceivable. The tests regulated in the Ph.Eur. often need to be performed in a multi-step process and cannot easily be expressed in merely one result.

Frequent tests are required for e.g. the representation of the dissolution (with and without Q), content uniformity (Ph.Eur. 2.9.6), mass variation (Ph.Eur. 2.9.40), impurity or contamination or linear regression. In general, the results must be represented in a table with lines and columns.

 

LAB+ I Special test methods - precisely coordinated program functions:

• illustration of the requirements of the Ph.Eur. within a test across process plant types
• each process plant type represents a specific test method
• direct evaluations via statistic features
• multiple steps can be illustrated in one test with one result (e.g. loss in drying)