Tablet IPC test


(Sajjad Ahmad) #1

what are Inprocess physical and chemical tests for tabs?


(Md.Asif Hussain) #2

General test:
Physical: Appearance/description
DT (Not applicable for chewable and SR Tabs)
Friability
Hardness
Thickness
Length/width

Chemical: Moisture contenT
Disso
Assay
RS
CU

Micro : MLT


(Sajjad Ahmad) #3

RS
CU stands for?


(Md.Asif Hussain) #4

Related substances
Content uniformity
Thanks


(Sajjad Ahmad) #5

kindly explain related substance test for tab?


(Sajjad Ahmad) #6

how moisture content and miro are chemical test?


(Md.Asif Hussain) #7

MC test is chemical test and done with Karl Fischer titration method.
Thanks


(Sajjad Ahmad) #8

Moisture contents are cheched by 2 method Karyl fisher
LOD
kyrl fisher just give water content
Lod give any solvent moisture content


(Md.Asif Hussain) #9

Related substances are the defined impurity level of any products and it’s pharmacology activity is known…
They are termed as

  1. Know impurity as A, B or xyz (generated during process of manufacturing)
    2.Metabolite of API.
    3.unknown impurity.

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


(Sajjad Ahmad) #10

thanks for explaning


(Saleemullah) #11

Micro: MLT, TYMC and Pathogen Test is requird.


(amit salunkhe) #12

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??