Stability Studies

For a 503A compounding pharmacy, the beyond-use date (BUD) is one of the most limiting numbers on a label. Without supporting data, USP <797> defaults are short — a matter of days — forcing small batches, tight scheduling, and steady waste. The way out is a stability study: data that justifies a longer date.

We sell turnkey stability studies for 503A pharmacies that want to extend Category 2 or Category 3 BUDs — one engagement covering every required test, configured to your regulatory environment.

Under USP <797> (2023), longer dates are still capped by category limits, and using a Category 3 BUD requires your pharmacy to qualify and operate as a Category 3 facility which has other requirements including regular MFT, training, etc.

Introduction to stability studies

An extended BUD promises that the formulation remains safe, sterile, and potent over that period of time. It justifies a date up to the category maximum — 30 days room temp / 45 refrigerated for Category 2, and 60 / 90 / 120 days (room temp / refrigerated / frozen) for Category 3 non-terminally sterilized products.

It validates two outcomes: chemical (API stays within potency spec and degradants below limits) and physical/microbiological (container-closure system holds, formulation resists growth, particulates remain within limits). A validation study is a coordinated panel of tests, repeated at intervals under defined storage conditions.

Available tests

• Stability-indicating method validated per USP <1225> — so a drop in active ingredient or rise in breakdown products is captured

• USP <51> Antimicrobial Effectiveness Testing — when a preservative system is present

• USP <1207> Container Closure Integrity Testing

• USP <788> / <790> particulate matter — sub-visible (providing assurance that nothing has precipitated out of the solution after storage) and visible.

• Sterility and Endotoxin

• pH — a sensitive indicator of formulation drift.

Design it with our configurator

No two formulations degrade alike, so a one-size schedule wastes money and leaves gaps. Our online configurator lets you choose the tests and intervals, then builds your study matrix.

Note the study runs in real time — a 90-day endpoint means pulls over 90 days — so make sure to plan well in advance of when you want to release your formulation.

Pricing

Studies start at $10,000 for a single API, covering the full panel across your time points. Multi-API formulations and longer timelines scale from there.

For a Category 3-capable 503A pharmacy, a study backs an extended beyond date — and for the right product it pays for itself in reduced waste and larger batches.

Contact us to configure a study.