Expertise & Lab Services / Pharmaceutical Analysis / USP <788> & <789>
USP <789>
USP <789> analysis is specifically done for ophthalmic solutions. The test is performed with the light obscuration method. In this case, however, a ≥50 μm particulate size is evaluated in addition to ≥10 µm and ≥25 μm sample sizes. <789> calls for testing via a microscopic approach if light obscuration is not applicable.
USP requires that a minimum of 25mL of the sample be used to run a particulate matter test to obtain statistically meaningful results. Provided the parenteral /ophthalmic sample container has a minimum of 25mL, the <789> samples can be analyzed with no further consideration. If the sample is less than 25mL, ten containers must be combined for sound testing.
<789> USP limits for the light obscuration test
Volume ≥ 10 μm:
- 6000 per container for small volume injections
- 25 per container for large volume injections
Volume ≥ 25 μm:
- 600 per container for small volume injections
- 3 per milliliter for large volume injections
<789> USP limits for the microscopic test
Volume ≥ 10 μm:
- 3000 per container for small volume injections
- 12 per container for large volume injections
Volume ≥ 25 μm:
- 300 container for small volume injections
- 2 per milliliter for a container for large volume injections
At Gateway Analytical, we provide USP <789> testing services and approaches that are optimal for diverse formula and dosage forms. We make it possible to trace the source of contamination in your drug development process. We provide expert help with our timely and thorough USP <789> particulate analysis procedures for accelerated product manufacturing and time to market.
We employ multi-tiered <789> analytical approaches. Our sample preparation techniques make it possible to test micron-sized particles that weigh much less than a few micrograms.
