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How many vials from a WWB lot should I send for a Karl Fischer water content test?

Asked 5 Feb 2026Modified 3 months agoViewed 4.6k times
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What I am working with: WWB · a Karl Fischer water content test.

I can do the algebra. I am not confident about the conversion factors.

If there is a standard way to lay this out, I would rather learn that than invent one.

Can someone show the working rather than just the answer?

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askednoor_alhassan11k275 Feb 2026

1 Answer

Accepted answer first, then by votes
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Accepted answer

Batch testing establishes what can be claimed about the lot as a whole, and the sample size determines how much you can actually claim.

Stratified sampling — testing one vial from the top, one from the middle, and one from the bottom of a shipment — is cheap insurance against segregation.

More usefully, for a quantitative result like content, the acceptable range determines how many vials you need to test to establish the lot complies.

Sampling plans for pharmaceutical manufacturing are defined in ISO 2859 and ANSI Z1.4, and they are based on statistical sampling theory.

Worth noting that thermal excursions during shipping affect different vials differently, so the lot may not be homogeneous even if it left the factory that way.

The practical summary: a lot number without a sampling statement is a lot number without meaning.

edited 21 Apr 2026 by tobias_maartens — tightened the wording; no substantive change

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answered · acceptedtobias_maartens171k35830 Mar 2026
6Adding a vote because this deserves more of them. – h_pergande 5 months ago
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