Chromatography Forum

I need clarification. Following the ICH guidelines I read that for impurities with registered Specification below 1.0%, for example 0.5%, I must report the value with two decimal digits.
But what does reporting the value mean? Does my specification become 0.50? or remains 0.5?

For example 0.53 is in specification or not?

etaxene wrote:
I need clarification. Following the ICH guidelines I read that for impurities with registered Specification below 1.0%, for example 0.5%, I must report the value with two decimal digits.
But what does reporting the value mean? Does my specification become 0.50? or remains 0.5?

For example 0.53 is in specification or not?

If your specification maximum is listed as 0.5%, then 0.53% becomes 0.5%; so in specification.

If your specification maximum is listed as 0.50%, then 0.53% is out of specification.

Consumer Products Guy wrote:

etaxene wrote:
I need clarification. Following the ICH guidelines I read that for impurities with registered Specification below 1.0%, for example 0.5%, I must report the value with two decimal digits.
But what does reporting the value mean? Does my specification become 0.50? or remains 0.5?

For example 0.53 is in specification or not?

If your specification maximum is listed as 0.5%, then 0.53% becomes 0.5%; so in specification.

If your specification maximum is listed as 0.50%, then 0.53% is out of specification.

Thanks.. but why ICH declare that I have report the value with 2 digits?
So I don't have to approximate it?