USP <788> and USP <789>
USP <788> and USP <789> are standard, validated methods for analyzing foreign particles within injectable and ophthalmic pharmaceutical products.
The presence of foreign materials within injectable and ophthalmic drug products can have significant effects on product quality and safety. USP<788> and USP <789> are required tests for the release of injectable and ophthalmic drug products, respectively. We provide standard testing for compendial methods of USP <788> and USP <789> that allow our customers to understand the number and size of foreign particles within their injectable and ophthalmic drug products.
Gateway Analytical offers both Method 1 (LO) and Method 2 (MM) for these compendial methods.
Method 1 is an automated method performed using light obscuration to objectively count and size particles with a HIAC.
Method 2 is a manual method performed using microscopic techniques. This is performed when Method 1 either fails or is infeasible.
USP <788> and <789> Testing Services
Injectable and ophthalmic drug products should be free of particles that pose a great danger when introduced into either the bloodstream or eye. The risks include phlebitis, vein irritations, local tissue infarction, and anaphylactic shock, among others.
We leverage <788> and <789> testing approaches including light microscopy, micro FTIR spectroscopy, and SEM, and SEM/EDS for qualitative and semi-quantitative results. We provide our customers with data formats that both comply with USP methods and are easy to read and understand.
Particle detection and measurement are imperative to determine the safety and accuracy of your manufacturing processes. The standard tests are:
for pharmaceuticals that come in contact with blood and tissue
for those that come into contact with the human eye.
We don’t just identify the number and nature of particulate contaminants in your sample. Our USP testing processes can reveal where the contamination happened in your product development processes.
We will tell you exactly what needs to be audited in your manufacturing process. Let’s help you achieve compliance and minimize product recalls. Contact us today to learn more.
Contact us today to learn how our FDA-inspected facilities can meet your analytical needs.