MC gives only % of water in a substance(Low melting range
substance).But LOD result is a combination of water
content and other volatile organic solvents.And more over
Melting range of a substance has to be considered in case
of LOD. Substances whichever is having high melting point
is required for LOD checking.
M/c (moisture content) - It determine that how many quantity of water present in supplied sample. It generally check by Karlfisher.
LOD ( lose on Drying)- determine both water and non-volatile substance in supplied sample. It done in oven at 110'C for 1hr.
stability study is going on up to 3years for famotidine-USP but the pharmacopeia is revised and tlc test is replaced with hplc test. At the 4th year frequency the product is failed in hplc test .how can i assain the expiry or retest date and can i stop or continue the programme?