what is difference between drug products and drug substance?
Answer Posted / md. zafor iqbal
Drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
Drug substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient.
| Is This Answer Correct ? | 18 Yes | 4 No |
Post New Answer View All Answers
Why only hydroxy naphthol blue indicator is used for standardisation of 0.05M EDTA solution instead of solochrome Black T or Euriochrome Black T indicator which is used for all sample analysis with 0.05M EDTA solution?
what you do when compound having dwel wavelength?
if peak get problamatic then what require to do?
Ph meter can show more than 14 ph reading? Why ph range in between 1 to 14 only?
What is control room temperature and which guide line says?
what is definition of validation? which components are followed give detail?
Why perchloric acid used for potentiometric titration
if your impurity coeluting with each other in that situation how require to set specification? is it acceptable?
what are the standard methods for HPLC?
why we use Dichlorobenzene.nitrobezine.t-butyldi sulhate.for calibration of gc Head space
WHY pKa value is more important than pH value of the mobile phase in HPLC?
[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?
what is mean by 40 in the dissolution basket mesh size?
Loss of linearity in tkn analysis, possible reasons?
please explain about aluminium hydroxide assay