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Platform for ID, assay & purity<br />

Process Process Stage Process Operation Parameter list<br />

ID, Assay and chromatographic purity Instrumentation HPLC System X<br />

Data Acquisition System X<br />

Autosampler Vials X<br />

Reagents and solution Reagents X<br />

Mobile Phase A, B, C, D X<br />

Dilution Solvent X<br />

Blank Solution X<br />

Reference Solution 1, 2, 3 X<br />

Selectivity Solution X<br />

Sample Solution X<br />

Procedure HPLC Conditions X<br />

Sequence (X)<br />

Rinse Program X<br />

System Suitability X<br />

Chromatographic Characteristics X<br />

Identification test Identification of active (X)<br />

Calculations Resolution -<br />

Recovery of control solutions -<br />

Assay of active -<br />

A Companywide ELN as the Enabler for a Recipe Data Warehouse<br />

Pascal Maes 26<br />

Determination of related compounds -

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