Bromhexine hydrochloride (BRX) is widely applied as an active pharmaceutical ingredient of oral solutions and tablets for the treatment of the infections of the respiratory tract. However, fulfillment of the present regulations, required for the registration process of BRX, might constitute a challenge, due to the occurrence of (3RS)-6,8-dibromo-3-cyclohexyl-3-methyl-1,2,3,4-tetrahydroquinazolin-3-ium, specified as impurity E by European Pharmacopeia. To overcome this issue, a novel BRX orodispersible tablets (ODT) with improved chemical stability were developed that contain low level of impurity E. Herein the analytical methods, elaborated for the determination of BRX and the related impurities in this product are presented. Stability of the product was tested at accelerated (ACC), intermediate (INT) and long-term (LT) conditions for ICH zones II and III. The degradant E was the most common impurity detected. In the samples stored in INT and LT conditions only a slight increase in the impurities and a slight drop in the assay of the BRX was observed, however the results did not exceed the pre-established acceptance criteria. In the samples stored at ACC conditions, an increase of the known impurities, including degradant E, degradant B and N-oxide, was noted. Noteworthily, even after three years of the product’s shelf-life, the level of the degradant E is still below 0.2 % which corresponds to the ICH identification threshold for the BRX related impurities.
The article discusses the vernacular wooden architecture Naleczow and surrounding areas. He forged in the shadow of stylish architecture spas in the second half of the nineteenth century. Unchanged was implemented in the form of "Naleczow" standard of the mid-twentieth century. Societal changes resulted from the liquidation of the mid-twentieth century, these objects, or eclectic adaptations and remodeling. The presented work is a preliminary study of the needs and possibilities of adapting a wooden object vernacular to contemporary requirements and functional. Designs August realize this by building a solid building natural building technologies, using straw and green clay. The intention is to create an object vernacular, combining modernity with tradition.
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