Problem rounded

Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.

3 posts Page 1 of 1
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?
3 posts Page 1 of 1

Who is online

In total there is 1 user online :: 0 registered, 0 hidden and 1 guest (based on users active over the past 5 minutes)
Most users ever online was 599 on Tue Sep 18, 2018 9:27 am

Users browsing this forum: No registered users and 1 guest

Latest Blog Posts from Separation Science

Separation Science offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques.

Subscribe to our eNewsletter with daily, weekly or monthly updates: Food, Environmental, (Bio)Pharmaceutical, Bioclinical, Liquid Chromatography, Gas Chromatography and Mass Spectrometry.

Liquid Chromatography

Gas Chromatography

Mass Spectrometry