Hi
Is it necessary to validate a test method for Loss on Drying? I would appreciate if a reference can be provided for a guidance document or protocol for method validation for Loss on Drying.
Regards, Shaun
Hi Shaun, is the Loss on Drying method you using a new way of doing loss on drying or an establish USP/BP method?
The Loss on Drying method is an established USP/BP method. However, we are testing a new product which is not listed in the pharmacopoeias. We therefore do not know if the loss on drying method we are using is suitable for the specific product.
If you going to use the USP Loss on Drying method than the following statement from the USP will help you. “The procedure set forth in this chapter determines the amount of volatile matter of any kind that is driven off under the conditions specified.” You may use the USP method for Loss on Drying without any method validation. I hope this helps. I’ve also send you a private message (check under notifications) and I emailed you.
I will explore this path and see what fruits it delivers. Thank you for the input - much appreciated.
Regards,
Not necessary, the methods addressed in the general chapters may not require any validation.(Eg: LOD, Moisture content etc…)
agree with bujjikanchi. in this condition, what we should do is performance qualification for each instrument(s) used in the procedure (burrettes, oven, etc).
Performance qualification of instrument is a part of calibration, as per schedule we verify.
Performance qualification of method is called Validation.
Hence no need to corelate the method in this case with the instrument when we do the performance individually.