Chromatography Forum

Perhaps some of you pharmaceutical chemists can help me out.

We've recently begun using a new excipient (flavoring) in a pharmaceutical oral dosage form. The CofA from the manufacturer lists "Total Sugars" with "Trace" as the specification limit. Their analytical method is via colorimetric titration.

My question: How does one objectively quantitate "Trace?" Is th a compendial (USP, EP...) definition out there somewhere? I've spoken to the vendor and they indicate that their actual result is usually "not detected" and since they haven't used this particular material in pharma products this issue has never come up for them.

Any thoughts?
Thanks,
Jeff

You need to find another vendor. If they list the amount as "Trace", they should be able to tell you what it means. That said, it probably means below LLOQ but above LOD.

Thanks, Tom. That sounds like a perfectly reasonable definition to me.

I've spoken with our formulators and they add an amount of sugar into the product anyway. So from a finished product perspective (my company's interest), it's really a moot point. A trace amount of sugar in a minor excipient is negligible as far as the identity, strength, purity and quality of our product.

As far as the vendor, they are willing to work with us to meet our specific needs, they just have not dealt with this issue before. For them, "Trace" is just that - a low enough amount such that it will not affect the batch-to-batch flavor of the ingredient.

It's just been a lesson learned - Know the reason behind the specifications you set...

It's just been a lesson learned - Know the reason behind the specifications you set...

Really good point -- and one that's easy to lose sight of in the rush to get things done!