Spray Content Uniformity for Nasal Products

A test to assess pump-to-pump reproducibility in terms of drug product performance and to evaluate the delivery from the pump should be performed. The proper performance of the pump should be ensured primarily by the pump manufacturer, who should assemble the pump with parts of precise dimensions. Pump spray weight delivery should be verified by the applicant for the drug product. In general, pump spray weight delivery acceptance criteria should con- 

The amount of active ingredient per determination is not outside 80 to 120% of label claim for more than two of 20 determinations (10 from beginning and 10 from end) from 10 containers 

None of the determinations is outside 75 to 125% of the label claim The mean for each of the beginning and end determinations is not outside 85 to 115% of label claim 

If the above acceptance criteria are not met because three to six of the 20 determinations are outside 80 to 120% of the label claim, 14 units but none are outside 75 to 125% of label claim, and the means for each of the beginning and end determinations are not outside 85 to 115% of label claim, an additional 20 containers should be sampled for second-tier testing. 

For the second tier of testing of a batch, the acceptance criteria are met if 

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