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At least 19 recordsLinked to original sources

Drug contamination from opening glass ampules.

Recently there have been several reports of postoperative sepsis due to the intravenous injection of contaminated solutions of propofol (Diprivan). The mechanism by which this contamination occurred has not been identified. This study sought to determine whether bacterial contamination of the contents of glass ampules can be decreased by swabbing the neck of the vial with alcohol prior to opening. Glass ampules of 1% propofol and 1% lidocaine were swabbed with a solution of Staphylococcus epidermidis. Half of these ampules were subsequently wiped with alcohol pads prior to being opened. An aliquot from each ampule was pipetted into a nutrient broth and allowed to incubate overnight at 37 degrees C. These solutions were plated on agar, incubated for 24 h, and then examined for bacterial growth. Three of the eight lidocaine ampules and six of the eight propofol ampules not cleaned with alcohol demonstrated evidence of bacterial contamination. The contents of all ampules that had been wiped with alcohol prior to being opened remained sterile (P less than 0.001 vs. non-alcohol-treated group for propofol ampules and P = 0.20 vs. non-alcohol-treated group for lidocaine ampules). These data suggest that bacterial contamination of propofol and lidocaine may occur as a result of opening glass ampules. Wiping the outside of the ampule with alcohol immediately prior to opening may decrease this risk.

Alcohols

Drug contamination of mortars and pestles.

Evidence is presented suggesting that potent water-insoluble antipentylenetetrazol agents triturated in porcelain mortars and pestles are not removed from this mixing device by the usual laboratory washing procedure. Moreover, amounts sufficient to contaminate the next substance triturated in this vessel can be demonstrated by the subcutaneous pentylenetetrazol seizure threshold test. The data show that a rigorous washing routine must be followed to achieve a "clean" mortar and pestle. Attention is also directed to the importance of using disposable hypodermic syringes, test tubes, etc., whenever possible and of designing an internal control test to determine when implements that must be reused are "clean."

Animals

Potentiometric determination of acid-base contaminations in drugs.

A potentiometric method for the determination of impurities in pharmaceuticals with acid-base behaviour is proposed. Based on proton balance condition, appropriate equations for the treatment of the data are derived. The latter in combination with Gran's equations allow the determination of acid-base impurities in pharmaceuticals--weak protolytes. The proposed method is quick, accurate and precise. It is suitable both for technical control and for analyses according to the pharmacopoeias.

Acids

Carcinogenic N-nitrosodimethylamine as a contamination in drugs containing 4-dimethylamino-2,3-dimethyl-1-phenyl-3-pyrazolin-5-one (amidopyrine, aminophenazone).

A total of 68 commercially available drugs containing amidopyrine were investigated for contamination with the strong carcinogen N-nitrosodimethylamine (NDMA). All samples contained varying amounts of NDMA. About half of the drugs contained 1--10 micrograms/kg, 40% contained 11--50 micrograms/kg, 7% contained 51--10 micrograms/kg and one sample had 370 micrograms/kg. NDMA-contents in batches of pure amidopyrine that had been utilized for preparation of drugs were higher than those in the respective drugs: about one-third was in the range of 20--50 micrograms/kg, one-third had 51--100 micrograms/kg, and one-third was above 100 micrograms/kg. There was, however, no correlation between NDMA-contents of batches of the pure substance and NDMA-contents of the drugs prepared from these batched. NDMA concentrations in the samples were inhomogenously distributed. It could be demonstrated that amidopyrine in substance reacts extremely rapidly with nitrogen oxides from the air to form NDMA. Ascorbic acid, which prevents nitrosamine formation in aqueous-acidic solution, under these conditions had no protective effect.

Aminopyrine

Studies on contamination of vegetable drugs with halogen derivative pesticides. Part 1: Changes of concentrations of halogen derivatives in herbal raw materials within the period of 1980-1984.

Levels of concentration of halogen derivatives (p,p'-DDT with metabolites p,p'-DDD and p,p'-DDE, HCH, DMDT, aldrin, dieldrin) and their changes in herbal raw materials commercially manufactured in Poland within the period of 1980-1984 have been analyzed (qualitative analyses by TLC, quantitation by GLC). Higher levels of these compounds in 1982 as compared with the periods of 1980-1981 and 1983-1984 has been noticed.

Chromatography, Gas

Detection of amphetamine and methamphetamine-type materials in pharmaceutical and biological fluids by fluorometric labeling.

A rapid and sensitive method for detecting amphetamine and methamphetamine in drug preparations and biological fluids has been developed. Amphetamine and methamphetamine in pharmaceutical and clandestine drug preparations can be easily screened from other contaminating drugs and readily identified by their fluorescence, with subsequent separation accomplished by TLC. The same general procedure can also be used to detect amphetamine and methamphetamine in human urine at concentrations of 0.1 mug/ml.

4-Chloro-7-nitrobenzofurazan

[Quantitative analysis of particulate matter in infusion solutions, administration sets and additives (author's transl)].

There have been recevitly many comments on clinical and experimental reports which have demonstrated the safety problems associated with parenteral drugs contaminated with particles. Some countries have developed recommendations with a standard for counting of particles and their limits. Based on these limits, we have made a critical quantitative analysis of particulate matter in the most common commercially produced solutions, of particles added during manipulations in clinics and addition of drugs. Most authorities agree that particulate contamination should be kept to a minimum, above all in an intensive-care-unit where patients receive large quantities of solutions. As the risk to the patient is unacceptably high, many authors ask for filters to prevent the injection of particles in the bloodstream and their pathological consequences. A filter pore-size of 5 to 10 micron should be able to reduce this problem in a sufficient manner, without decreasing the infusion flow; whereas membrane-filters (0.22 micron), with their own problems, could also eliminate bacteria together with their microbiological hazards. Another source of particulate matter is represented by the injection of two or more drugs, administered at the same time, which may lead to chemical incompatibilities. This problem is not yet defined very well. To complete our quantitative analysis, we decided to start a prospective clinical study.

Critical Care

Toxic risks of inappropriate therapy.

Drug therapy may produce toxicity. Patient individuality or drug interactions account for many cases of poisoning, but other factors such as genetic predisposition, drug contamination or human error are also known causes. Examples of various types of drug poisoning are given, illustrating the role of the clinical chemist in minimizing or studying drug toxicity.

Drug Interactions