The European Pharmacopeia (EP) and the United States Pharmacopeia (USP) pyrogen test
for parenterals involve the measurement of the temperature rise in rabbits following the …

Rabbits, 27 or 36 in each experiment, were injected with the International Pyrogen Standard
(IP St.) in different seasons. The maximum temperature rises were registered, randomized …

Although the rabbit pyrogen test is one of the crucial methods included in each
pharmacopeia to evaluate the safety of parenteral medicine, the experimental procedures …

Rabbits generally numbering 27 or 36 in each experiment were injected in 1970 with doses
of the pyrogenic preparation Pyrago (HUMAN) and in 1971-72 and 76 with doses of the …

Previously we have published a series of papers comparing the requirements of various
world pharmacopoeias with respect to the pyrogenic effect of drugs [1-6]. These works …

The handling technique in pyrogen testing influences the temperature of rabbits. The
thermocouple‐box method described in this paper minimizes handling which results in …

The in vivo pyrogen test is the main toxicological assay used in the quality control of
injectable products, especially immunobiologicals. Pharmacopoeias state that, before the …

There are many steps involved in developing a drug candidate into a formulated medicine
and many involve analysis of chemical interaction or physical change. Calorimetry is …

As a result of the Process Analytical Technologies (PAT) initiative launched by the US Food
and Drug Administration (FDA), analytical development is receiving more attention within the …

Abstract Significant Thermal Analysis-physical chemical data needs to be acquired by the
new analyst whether an entry level chemist or a new function for the experienced …