What is usp788?

The USP <788> Particulate Matter in Injections test is used to quantify the count and size of subvisible particles in parenteral drugs. The test calls for using a light obscuration particle counter and counting particles on a filter by microscopy.

What is light obscuration?

Light obscuration works by passing a dilute stream of particles in a liquid suspension between a light source and a detector. In the HIAC 9703+ liquid particle counter, the light source is a laser diode, which illuminates individual particles in the stream to generate a shadow or blockage of light on the detector.

What are Subvisible particles?

Subvisible particles are usually defined as particles that are too large for analysis by size exclusion chromatography (SEC) (e.g., ~ > 0.1 μm), but too small to be visible to the unaided eye (e.g., < 100 μm).

What is microscopic particle count test?

Microscopic Particle Count Test Utilized when certain test articles cannot be analyzed by the Light Obscuration method due to color, reduced clarity and/or viscosity. This method can also be utilized in the event a product does not meet the USP criteria for the Light Obscuration Method.

What size are visible particles?

approximately 100–150 µm
Particles also come in a variety of sizes. There are visible particles (approximately 100–150 µm and larger), which can be spotted with the naked eye during visual inspection and without any outside assistance such as magnifying glasses or microscopes.

Is USP 788 required for parenteral products?

For those creating parenteral products for veterinary use, solutions used for irrigation alone, or radiopharmaceutical preparations, particle matter regulation requirements of USP 788 do not need to be met.

What is chapter 788 of the United States Pharmacopeia?

Chapter <788> of the United States Pharmacopeia (USP) is harmonized with Chapter 2.9.19 of the European Pharmacopoeia, and Japanese Pharmacopoeia. These standards apply to most small- and large-volume parenteral products.

What do the symbols () mean in the USP text?

Portions of the present general chapter text that are national USP text, and therefore not part of the harmonized text, are marked with symbols ( ) to specify this fact. Particulate matter in injections and parenteral infusions consists of mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.