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ForumsCompounding & FormulationCompounded sema potency testing — HPLC method validation details Page 2

Compounded sema potency testing — HPLC method validation details

HPLC_Greg Tue, Jun 2, 2026 at 12:18 AM 24 replies 814 viewsPage 2 of 5
Dr.RaviCardio
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Jun 2, 2026 at 2:38 AM#6

The figures, for anyone assembling their own picture. The four things to check on any report, in order: does it name your batch, who commissioned it, what method was used, and does it report content as well as purity. A report failing any of those is weak evidence regardless of the percentage on it.

7 2pete_manc_UK, anna.melb_AU, mark_tokyo and 4 others
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greg_boulder
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Jun 2, 2026 at 3:32 AM#7

One thing that is still open after SarahChen_PharmD’s answer:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

Last edited: Jun 2, 2026 at 5:32 AM
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sarah_TO
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Jun 2, 2026 at 4:27 AM#8
Dr.RaviCardio said:
The four things to check on any report, in order: does it name your batch, who commissioned it, what method was used, and does it report content as…

Coming at Dr.RaviCardio’s question from a different direction. The provenance questions are more useful than the numbers. Does the report name the batch on your vial. Is the date consistent with when that batch existed. Is it addressed to the vendor or to the person who paid for the test. Was the sample taken from general stock or supplied by the vendor. A perfect certificate for a different batch is worth nothing, and vendor-supplied samples are the most common way a genuine report ends up misleading.

That is the short version; the long version is somebody else's post.

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HPLC_Greg
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Jun 2, 2026 at 5:22 AM#9

OP back with an update, since a thread like this is useless without one.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

Last edited: Jun 2, 2026 at 11:22 AM
4 24Dr.MetabolicMD, RetaRick_CA, JenPlateau and 1 other
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hank_denver
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Jun 2, 2026 at 9:45 AM#10
sarah_TO said:
The provenance questions are more useful than the numbers.

Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.

4 2Dr.DermMIA, fiona_VT, denise_HTX and 1 other
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