الفهرس 
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Abstract
The aim of the study is to provide rapid practical solutions to resolving LAL test interferences appear during performing LAL tests in pharmaceutical Drug products and Drug substances. In addition, to pay the attention of clinical pharmacists and physicians in developing countries for the risk of combination of several parenteral drugs without taking into consideration the total endotoxin limit of this combination and whether it might exceed the threshold limit allowed for the endotoxin limit for the patient or not. and LAL test can be used as a rapid, simple, accurate and reliable screening procedure for the diagnosis of clinically significant gram-negative bacteriuria. The first interfering factors inhibiting or enhancement the endotoxins measuring in the LAL test was the suboptimal pH condition of the LAL reaction which was investigated to optimized the range of pH between 6-8. This factor was resolved by adjusting the pH by buffers for the sample and then dilute with LRW to finally resolve pH, using a dilution of the sample equivalent to the NIC or more dilute but without exceeding the MVD with LAL-reagent water (LRW). The second factor of the high concentration of the sample was resolved by using a dilution of the sample equivalent to the NIC or more dilute but without exceeding the MVD with LRW. The Inhibitory interference due to EDTA (unbalanced cation concentration) was the third one which is removed by using few drops of the buffer contains divalent cations pH7.2 as a diluents followed by LWR. The last factor was the gelation due to the protein content of the sample by lead to the enhancement interference and resolved by preheating of the sample at 90 °C for 15 min and then dilution by LRW respectively. After resolving the interference problems the validation of the final procedure was done. 7 samples from patients with UTI is collected and tested, 3 was gram negative and give positive LAL test and 4 was gram positive and give negative response with LAL test, The time required for LAL coagulation when urine was tested that containing ≥ 105 per ml of GNB elicited positive LAL test within 15 min incubation, so the current study showed good diagnosis of LAL to recognizing gram negative infection in UTI. The current study also showed. The risk of combination of several parenteral drugs without taking into consideration the total endotoxin limit of this combinations which might exceed the threshold limit allowed for the patient. Therefore, this study recommended that, if the endotoxin limit of the co-administrated drugs exceeds the allowed limit the administration of this combination should be organized in a time dependent manner. This risk could be avoided by prolonged infusion time.