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Development and validation of HPLC-UV method for the quantitative analysis of carcinogenic organic impurities and its isomers in the sodium polystyrene sulfonate polymer

Zinjad Pushpavati, Gondhale Priyanka, Kulkarni Shrikant, Musmade Bhaskar, Bhope Shrinivas, Padmanabhan Sriram

Acta Chromatographica

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2021

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Vol. 33, no. 2

162--169

EN

Sodium polystyrene sulfonate (SPS) powder is in use for over 50 years for the treatment of hyperkalemia. SPS powder is official in United States Pharmacopoeia, British Pharmacopoeia and European Pharmacopoeia. However, till date, no study has been published on the assessment of organic impurities for this drug. The organic impurities in bulk drug and finished product are associated with their safety, efficacy and stability. A simple, rapid, specific, precise and an accurate HPLC method has been developed for the estimation of toxic organic impurities like styrene, naphthalene, divinyl benzene (DVB) and ethylvinyl benzene (EVB) from SPS bulk drug and finished product. The developed method was validated for specificity, accuracy, precision, linearity, limit of detection (LOD), limit of quantitation (LOQ), solution stability, ruggedness and robustness. The influence of acid, alkali, oxidative stress, photolytic stress, thermal stress and humidity stress conditions on SPS bulk powder and finished product has been studied and reported. The proposed method can be successfully employed for the impurity testing of commercial batches of the bulk drug and finished products of both sodium salt and calcium salt of polystyrene sulfonate.

2

Effect of Human Factor on Product Quality in Manufacturing Activities

Gruszka S., Gašpar Š.

Multidisciplinary Aspects of Production Engineering

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2018

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Vol. 1, Iss. 1

851--856

EN

Human factor, often referred to in the literature as human resources, is an important type of resources in an enterprise in ensuring the highest possible quality of products and meeting the needs of customers. The paper presents the question of influence of human factor on the quality of manufacture of the finished product in individual stages of the production process. This problem was presented based on literature analysis and on observations in a production business. Due to the ever-increasing significance of human influence on product quality, this issue is not only very timely, but is constantly being developed.

3

Variants of determining the manufacturing cost of a product in a production unit in the light of balance sheet law

Strojek-Filus M.

Management Systems in Production Engineering

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2014

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nr 1 (13)

13--19

EN

The category of the manufacturing cost of a product is one of the most important ones from the point of view of proper valuation of the assets of a production unit, costs of its operations as well as pricing decisions. This article presents the problem of determining the manufacturing cost of a product in terms of balance sheet law. It has been shown that in order to determine this value various methods and options are allowed by this law, by means of which different values of manufacturing cost of a product are obtained. The importance of a proper selection of an allocation key in settlement of indirect production costs has been highlighted as well as the results of using, in certain cases, approved simplifications in the balance sheet law when determining the manufacturing cost of products have been demonstrated. The problem presented in this article is crucial from the point of view of an organization and management of production as well as managerial decision‐making in a company in the area of design of products and processes.

PL

Kategoria kosztu wytworzenia produktu jest jedną z najważniejszych z punktu widzenia prawidłowej wyceny majątku jednostki produkcyjnej, kosztów jej działalności oraz decyzji cenowych. W artykule przedstawiono problematykę ustalania kosztu wytworzenia produktu w ujęciu prawa bilansowego. Wykazano, że prawo to dopuszcza różne metody i warianty ustalania tej wielkości, przy których uzyskiwane są różne wartości kosztu wytworzenia produktu. Podkreślono znaczenie prawidłowego doboru kluczy rozliczeniowych w rozliczaniu kosztów pośrednich produkcyjnych oraz wykazano skutki stosowania dopuszczonych, w określonych przypadkach, w prawie bilansowym uproszczeń w ustalaniu kosztu wytworzenia produktów. Problematyka zaprezentowana w artykule jest istotna z punktu widzenia organizacji i zarządzania produkcją oraz podejmowania decyzji menedżerskich w przedsiębiorstwie w obszarze projektowania wyrobów i procesów.