Related substance method validation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

If there is no any known impurity in the product then how to do the related substance method validation.
for eg. in one product impurity limit is
Any unspecified impurity - NMT 0.5%
Total impurity - NMT 2.0%

So any reference or guideline for the these method validation

2

You have to prove it! Perform ‘forced degradation’ up to 5 days (acid, base, heat, light, oxidation). Maximum degradation 10-15% of the API concentration.

Then prove your method is ‘stability indicating’. Mass balance should be 100% if there are no RS.

Then maybe…

3

References are ;

  1. ICH Q3 for related substances.

  2. ANUSA 2003 for ‘forced degradation’.

  3. The analytical method MUST comply with ICH Q2(r1).

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