Products Tested

Inhaled Products

NDA Analytics has been testing inhaled products since the early 1990s and, during that time, we have built up a depth of expertise in the specialised and challenging techniques associated with testing of these products. We have many years' experience in testing both pressurised metered dose inhalers (pMDIs) and dry powder inhaler devices (DPIs) and we can also provide testing of nasal spray products. The tests offered include:

General tests

• Assay of active ingredient
• Assay of related impurities and degradation products
• Cascade impactor (Andersen) testing (USP/EP)
• Twin impinger testing
• Multi-stage liquid impactor testing (MSLI)
• Water content by Karl-Fischer titration (volumetric and coulometric)
• Emitted dose
• Dose uniformity through life
• In-use assessment
• Foreign particulate matter determination
• Microbial limit tests (USP).

pMDI specific tests

• Determination of total can content assay ("freeze and cut" and "expel and cut")
• Appearance of can contents under pressure
• Spray pattern assessment
• Valve leakage tests
• Storage orientation evaluation.

DPI specific tests

• Bulk blend homogeneity assessment
• Device cleaning assessment.