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The following absolute rate constants of the reactions of eaq⊖ and OH with dimethylthioether and dimethylsulfoxide have been determined: k (eaq⊖ + CH3SCH3) =2.0·107 mol-1 l sec-1; k(e⊖+ CH3SOCH3) =1.7·106; k(OH+CH3SCH3) =5.2·109; k(OH+CH3SOCH3) =4.2·109. The acid and basic components of the equilibriumare formed in the reactions of OH+CH3SCH3 and eaq⊖ +CH3SOCH3, respectively. The anion absorbs at 3500 Å. The ρK value of the equilibrium was found to be equal to 10.2. The CH2SCH3 radical (2900 Å) and the ions CH3SCH3⊕ or (CH3SCH3)2⊕ (4700 Å) are also formed in the reaction between OH and CH3SCH3. High thioether and low OH⊖ concentrations favour the formation of the positive ion which is believed to result from a reaction between CH3SOHCH3 and CH3SCH3.

The study indicates that the TGA is able to reliably predict procoagulant activities probably associated with the presence of FXIa and potential thrombogenicity. Comparison of thrombin generation with product-specific acceptance criteria as well as variables from other test systems as amidolytic activity and molecular size can help to monitor IgG quality and manufacturing changes with regard to thrombogenicity.

BackgroundCounterfeit and unapproved medicines are inherently dangerous and can cause patient injury due to ineffectiveness, chemical or biological contamination, or wrong dosage. Growth of the counterfeit medical market in developed countries is mainly attributable to life-style drugs, which are used in the treatment of non-life-threatening and non-painful conditions, such as slimming pills, cosmetic-related pharmaceuticals, and drugs for sexual enhancement. One of the main tasks of health authorities is to identify the exact active pharmaceutical ingredients (APIs) in confiscated drugs, because wrong API compounds, wrong concentrations, and/or the presence of chemical contaminants are the main risks associated with counterfeit medicines. Serious danger may also arise from microbiological contamination. We therefore performed a market surveillance study focused on the microbial burden in counterfeit and unapproved medicines.MethodsCounterfeit and unapproved medicines confiscated in Canada and Austria and controls from the legal market were examined for microbial contaminations according to the US and European pharmacopoeia guidelines. The microbiological load of illegal and legitimate samples was statistically compared with the Wilcoxon rank-sum test.ResultsMicrobial cultivable contaminations in counterfeit and unapproved phosphodiesterase type 5 inhibitors were significantly higher than in products from the legal medicines market (p < 0.0001). Contamination levels exceeding the USP and EP limits were seen in 23% of the tested illegal samples in Canada. Additionally, microbiological contaminations above the pharmacopoeial limits were detected in an anabolic steroid and an herbal medicinal product in Austria (6% of illegal products tested).ConclusionsOur results show that counterfeit and unapproved pharmaceuticals are not manufactured under the same hygienic conditions as legitimate products. The microbiological contamination of illegal medicinal products often exceeds USP and EP limits, representing a potential threat to consumer health.