Норма

05:31 Aug 2, 2016 

Thank you, Macro!

02:13 Aug 2, 2016 

@Artyom: I was right about "standard". Here is an aria from Norma for you:
https://www.youtube.com/watch?v=JlSodSvo1Lg
(singing starts at 1:40).
A bit different from Bob Dylan.

17:55 Aug 1, 2016 

I'm more accustomed to Bob Dylan, but I'll check out Bellini.

Maybe "Requirements:" would also fit.

Or maybe one could omit the word altogether, since it is a bit excessive. The company itself produces the drug product, and is unlikely to break its own standard. It's that the word "норма" is useful in the neighboring paragraphs, where it's used to describe the ranges or values, like "Limits: clear colorless liquid". Or mayb it's better as "Standard: clear colorless liquid" too.

I'll re-read ICH documents to look what word might be used there.

15:56 Aug 1, 2016 

You might want to listen to Norma by Bellini instead. On the other hand, these look like standard sizes.