Tablet IPC test

Quality Control
1

what are Inprocess physical and chemical tests for tabs?

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

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3

RS
CU stands for?

4

Related substances
Content uniformity
Thanks

5

kindly explain related substance test for tab?

6

how moisture content and miro are chemical test?

7

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

8

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

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

1 Like
10

thanks for explaning

11

Micro: MLT, TYMC and Pathogen Test is requird.

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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??