product specifications

Question 1

Specification

Answer 1

Describes test and criteria of a drug product and may refer to the assay to allow the release of a a manufactured batch

Question 2

Analytical procedures

Answer 2

Detailed description of the assay for the substance (drug product, drug substance or excipients)

Question 3

Validation of the analytical procedures

Answer 3

demonstrate the assay has sufficient sensitivity and reproducibility to reliably quantify the amount of drug (i.e. in the product or during the dissolution test)

Question 4

Batch analysis

Answer 4

provides results of batches that have been tested for the purpose of demonstrating that you can make batches that comply with the specification

Question 5

Justification of specification

Answer 5

-why the limits you have sent are reasonable i.e. its an IR it should dissolve within 40 mins