Finished product testing will be performed as per guidelines by FDA. All finished products must be tested prior to distribution. The tests that are performed will ensure that the product meets established specifications and that these specifications account for its purity, integrity, efficacy, and concentration. The tests can include titrations, Spectrophotometer, pH, conductivity, HPLC, GC, AA, and others
Pharmaceutical equivalence studies (Comparative dissolution profile) is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. At Prime Health comparison of therapeutic performances of two medicinal products containing the same active substance will help assessing the possibility of alternative using between the innovator and any essentially similar medicinal product.
Prime Health raw material testing will help provide purity, contamination, Residual Solvents and material testing services, for a variety of raw materials. Raw material quality control is necessary to prevent product failure and ensure a consistent level of quality, as well as safety in consumer and industrial products.
Stability testing (Using stability indicating methods) at Prime Health Lab will help to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability Storage is structured as multiple chambers, which are designed to meet various temperature conditions, required by FDA and ICH, as well as other conditions required specifically by the client. All of storage chambers are continuously monitored by a computerized system, with temperature and humidity set-point windows at ±2° C and ±5°RH.