Bioluminescence for USP sterility testing of pharmaceutical suspension products

Bioluminescence for USP sterility testing of pharmaceutical suspension products.

Bioluminescence measurement significantly improved the accuracy, sensitivity, precision, and reliability of the current visual endpoint determination for the USP sterility test and eliminated the day 7 transfer/dilution step required for testing suspension products. Thirteen strains of bacteria and fungi (representing potential contaminants in sterile products), three pharmaceutical suspension ...

Cephalexin for Oral Suspension Usp

Cephalexin for Oral Suspension, USP, is a pink colored powder forming pink colored suspension on constitution. After mixing, each 5 mL of cephalexin for oral suspension, will contain cephalexin USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of anhydrous cephalexin. The suspension also contains the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40, sodium benzo...

Comparison of endotoxin testing methods for pharmaceutical products.

Roughness Model for Adhesion Testing of Pharmaceutical Coating Materials

Objective Roughness is the main parameter in interlocking bonding mechanism. Yet there is no model designed to evaluate the effect of surface roughness on adhesion of coating materials in pharmaceutical sciences. Materials and Methods In this study polymethyl metacrylate spherical beads with different sizes were poured into 10 mm mold, then it was pressed by hand screw and finally heated to 141...

Application of the BacT/ALERTR 3D system for sterility testing of injectable products

Sterility testing as described in the pharmacopoeia compendia requires a 14-day incubation period to obtain an analytical result. Alternative methods that could be applied to evaluating product sterility are especially interesting due to the possibility of reducing this incubation period and thus the associated costs. The aims of this study were to evaluate the performance of the BacT/ALERT(R) ...