what are Inprocess physical and chemical tests for tabs?
DT (Not applicable for chewable and SR Tabs)
Chemical: Moisture contenT
Micro : MLT
CU stands for?
kindly explain related substance test for tab?
how moisture content and miro are chemical test?
MC test is chemical test and done with Karl Fischer titration method.
Moisture contents are cheched by 2 method Karyl fisher
kyrl fisher just give water content
Lod give any solvent moisture content
Related substances are the defined impurity level of any products and it’s pharmacology activity is known…
They are termed as
- Know impurity as A, B or xyz (generated during process of manufacturing)
2.Metabolite of API.
The limits are defined for these impurity…
During FP analysis the test results of RS should meet the requirements of limit…
Higher side of these impurity is alarming for stability failure for products…
thanks for explaning
Micro: MLT, TYMC and Pathogen Test is requird.
may i know why they add known impurity during standard preparation to compare with any tablet test solution
is there any impurity already available in such kind of tablets which get compared with standard impurity ?? if yes then why it don’t effect tablets quality??