Chromatography Forum

I have two results out of ten tablets getting out of specs values but I'm getting an acceptance value that is passing. Is this just okay? thanks.

I would think that if you have a tablet that is out of spec, regardless of the fact that the set of 10 passes the acceptance value, it would fail.

What do your SOPs say? If they *don't* say, why not?

What are your acceptance criteria? What is the uncertainty in your method? What was the RSD in this set of 10? How far out were the two that failed?

I have two results out of ten tablets getting out of specs values but I'm getting an acceptance value that is passing. Is this just okay? thanks.

What do you mean by "out of spec"? Specification for assay?
The only (!) specification for L1 (10 single dosage forms) content uniformity is the acceptance value! Content uniformity is NOT assay.
Only if L1 does not pass, there are additional specifications concerning single values for L2.

I have two results out of ten tablets getting out of specs values but I'm getting an acceptance value that is passing. Is this just okay? thanks.

What do you mean by "out of spec"? Specification for assay?
The only (!) specification for L1 (10 single dosage forms) content uniformity is the acceptance value! Content uniformity is NOT assay.
Only if L1 does not pass, there are additional specifications concerning single values for L2.

yes, what I mean is the specification for assay of the individual tablet

As I said, for L1 of content uniformity according to the pharmacopoeias there is only one specification: the acceptance value. There is not such a thing as "assay of individual tablet".
Only if the acceptance value L1 (with 10 tablets) is not fulfilled, you have to test L2 which includes a specification for each single tablet.
"Assay" usually includes testing of a homogenous "bulk" sample (such as a tablet trituration). "Content uniformity" and "assay" are two distinctive test with distinctive specifications. A single tablet doesn't have to comply with the specification for assay testing of a bulk sample.

This applies to content uniformity testing according to the pharmacopoeias. If you have different or additional specifications in the respective technical dossier or in your internal SOPs then, well, you're busted .

Please read Ph. Er 2.9.6. or USP 905.

Please read Ph. Er 2.9.6. or USP 905.

Ph.Eur.2.9.6 is outdated. You should read 2.9.40.

Please read Ph. Er 2.9.6. or USP 905.

Ph.Eur.2.9.6 is outdated. You should read 2.9.40.

thanks

Please find the clarification of the Ph.E.:

"Taking this into account, the decision on what approach to take is left to the applicant. Application of either the Ph. Eur. harmonised general chapter on uniformity of dosage units (2.9.40) or the Ph. Eur. general chapters on uniformity of mass of single-dose preparations (2.9.5) and uniformity of content of single-dose preparations (2.9.6) are both considered acceptable options to demonstrate compliance with the Ph. Eur. with regard to uniformity of dosage units."

2.9.40 is harmonised to USP
Where as the 2.9.6 is still in force. (not outdated!).
Tabs are single dose preparations by the way.

Kind Regards

Please find the clarification of the Ph.E.:
"Taking this into account, the decision on what approach to take is left to the applicant. Application of either the Ph. Eur. harmonised general chapter on uniformity of dosage units (2.9.40) or the Ph. Eur. general chapters on uniformity of mass of single-dose preparations (2.9.5) and uniformity of content of single-dose preparations (2.9.6) are both considered acceptable options to demonstrate compliance with the Ph. Eur. with regard to uniformity of dosage units."
2.9.40 is harmonised to USP
Where as the 2.9.6 is still in force. (not outdated!).

Since the OP mentioned the acceptance value, we're talking about 2.9.40.
But generally you're right - I was under the impression that 2.9.5 and 2.9.6 are accepted for marketed products only, whereas for new products 2.9.40 is mandatory nowadays. A little googling revealed that this requisite seems to have changed. Nice to know.

Tabs are single dose preparations by the way.

Erm, yes. So what? They are dosage units, too