[Microbiological and biological methods of the European Pharmacopoeia. Relevant for each medicinal product]. / Mikrobiologische und biologische Methoden des Europäischen Arzneibuchs. Relevant für jedes Arzneimittel.

According to the EU Directive 2001/83 the European Pharmacopoeia is the official Pharmacopoeia of the European Union. Therefore the European Pharmacopoeia is one of the legal pharmacopoeial compendia in Germany. Any licensed medicinal product on the German market complies with the requirements of the compendial monographs, if applicable. Because the general monographs of the European Pharmacopoeia on Dosage Forms, Substances for Pharmaceutical Use and Pharmaceutical Preparations refer to the microbiological and biological methods of the Pharmacopoeia, the methods are relevant for medicinal products, too. This article presents a rough summary of the microbiological and biological methods of the European Pharmacopoeia and is intended to be a stimulus for the reader to better understand the original compendia. The short description of the methods mentioned, here, is a summary from the Pharmacopoeia and the non-official collection of comments on the texts of the European Pharmacopoeia.

Prediction of the oversulphated chondroitin sulphate contamination of unfractionated heparin by ATR-IR spectrophotometry.

The detection of a contamination of heparin with oversulphated chondroitin sulphate (OSCS) was first analysed in an unfractionated heparin batch supplied to the US API-market in April 2006. OSCS is a semi-synthetic derivative of the natural occuring glycosaminoglycan chondroitin sulphate. Moreover some spectroscopic characteristics of the substance overlap with those of heparin, so that the infrared (IR) spectra are visually difficult to distinguish whereas (1)H-NMR (Nuclear Magnetic Resonance) spectroscopy or capillary electrophoresis (CE) provides identification by a simple visual inspection of either the spectrum or the electropherogram respectively. However, applying special tools of Multivariate Data Analysis (MVA) to the IR spectra an identification of the contaminated samples is possible. In detail a rapid Attenuation Total Reflectance-Infrared (ATR-IR) measurement was selected, which does not require any sample preparation. The result (contaminated or not contaminated) is predicted within a few minutes. A method transfer to mobile ATR-IR spectrometers seems to be possible. The analysis is based on the fact that the fingerprint of the OSCS IR spectrum (1st derivative) complies with a theoretically calculated principal component in the MVA.

Cerebral concussion in athletes: evaluation and neuropsychological testing.

OBJECTIVE: To conduct a topic review of studies related to cerebral concussion in athletes, as an aid to improving decision-making and outcomes. METHODS: We review the literature to provide an historical perspective on the incidence and definition of and the management guidelines for mild traumatic brain injury in sports. In addition, metabolic changes resulting from cerebral concussion and the second-impact syndrome are reviewed, to provide additional principles for decision-making. Neuropsychological testing, as it applies to athletes, is discussed in detail, to delineate baseline assessments, the characteristics of the neuropsychological evaluation, the neuropsychological tests used, and the methods for in-season identification of cerebral concussion. Future directions in the management of concussions are presented. RESULTS: The incidence of cerebral concussions has been reduced from approximately 19 per 100 participants in football per season to approximately 4 per 100, i.e., 40,000 to 50,000 concussions per year in football alone. The most commonly used definitions of concussion are those proposed by Cantu and the American Academy of Neurology. Each has associated management guidelines. Concussion or loss of consciousness occurs when the extracellular potassium concentration increases beyond the upper normal limit of approximately 4 to 5 mmol/L, to levels of 20 to 50 mmol/L, inhibiting the action potential and leading to loss of consciousness. This phenomenon helps to explain the delayed effects of symptoms after trauma. CONCLUSION: Neuropsychological testing seems to be an effective way to obtain useful data on the short-term and long-term effects of mild traumatic brain injury. Moreover, knowledge of the various definitions and management strategies, as well as the utility of neuropsychological testing, is essential for those involved in decision-making with athletes with mild traumatic brain injuries.