Assay result allowable criteria

Dear all,

In assay test specification limit is NLT 98.0% the result how much it should be allowed above 100%. In both potentiometry and by HPLC.


Please follow your specification for the assay and all other tests.

Generally, assay limits are given in the range. You may consider for higher limit as NMT 102% for both potentiometry & by HPLC.

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