Very small quantities parentals as like as Inj. Erythropoietin 0.5 ml prefilled syringe how mach sample are needed to perform LPC test according to USP requirement?
According USP we have different test procedure for based on fill volume of the container volume i.e USP 788 <25 ml <100ml >100 ml test 1.B A and test 1.B
So if your 0.5 ml sample fill volume container wil come under USP< 25ml Test 1.B test procedure is suitable for your LPC test.
So you say that at least 50 prefilled syringe are required to perform the LPC test but the batch size of product is only 1000 and this products are very expensive. So how I perform LPC Test in minimum sample?