Eco-friendly RP-HPLC method for determination of diazepam in coated tablet
Macedonian Journal of Chemistry and Chemical Engineering, 2023 A new eco-friendly RP-HPLC method for determining diazepam in coated tablets was developed and validated. The separation was achieved on a Lichrosper® 100 RP-18 (250 mm × 4 mm, 5 µm particle size) using the isocratic elution mode with a mobile phase ...
Marija Tomić +6 more
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Providing clinical evidence under the MDR 2017/745: New challenges for manufacturers in medical device industry [PDF]
Arhiv za farmaciju, 2019 Providing necessary clinical evidence throughout the systems for Clinical Evaluation and Post-Market Surveillance in accordance with new MDR 2017/745 requirements imposes new challenges for manufacturers in medical device industry.
Ivanovska Elena +5 more
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Macedonian Journal of Chemistry and Chemical Engineering, 2021 Fast and simple closed-vessel microwave-assisted digestion procedure was developed for decomposition of three pharmaceutical dosage forms of ibuprofen such as tablets, suspension and gel, prior to elemental impurity analysis by one robust and precise ...
Katerina Jancevska +4 more
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Macedonian Journal of Chemistry and Chemical Engineering, 2022 This research highlights the specificity of the new stability-indicating method developed to evaluate the impurity profile of Atorvastatin film-coated tablets. The proposed method has the ability to capture any possible changes that may occur during the
Elena Trajchova Kovachovska +6 more
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Investigation of the influence of critical process parameters in roller compaction process on physical properties of granules and tablets using design of experiments [PDF]
Arhiv za farmaciju, 2020 Different granulation methods are used in the pharmaceutical industry, mainly divided as wet or dry granulation. Although roller compaction is a widely used dry granulation process, the evaluation of critical process parameters has proven challenging ...
Atanaskova Elizabeta +2 more
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Complaints management in the pharmaceutical industry: A Case Study [PDF]
Makedonsko Farmacevtski BiltenEffective complaints management in the pharmaceutical industry is one of the cornerstones for ensuring product quality, regulatory compliance, and customer safety and satisfaction.
Marija Stojanovska +4 more
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Workflow for investigation of Out of Specification results in physico-chemical laboratory in Alkaloid [PDF]
Makedonsko Farmacevtski BiltenThe efficient and accurate investigation of Out of Specification (OOS) results is crucial in maintaining the reliability and quality of products in a physico-chemical laboratory.
Andrea Alagjozovska +8 more
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Advantages of trend analysis in stability studies for prediction of potential OOS result within estimated shelflife of medicinal product [PDF]
Makedonsko Farmacevtski BiltenStability studies are crucial for pharmaceutical product registration, providing vital data to assess batch-to-batch consistency, monitor critical quality attributes, and ensure the product's quality, safety, and efficacy over its entire shelf life ...
Milena Nanov +4 more
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Analysis of alkaloids (indole alkaloids, isoquinoline alkaloids, tropane alkaloids)
, 2020 Alkaloids are a large cluster of molecules found in Mother Nature all over the world. They are all secondary compounds and collection of miscellaneous elements and biomolecules, derived from amino acids or from transamination. This diverse chemical group is categorized, based on the amino acids that deliver their nitrogen atom and part of their ...
Dey, Prasanta +7 more
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Optimization of a forced degradation study of atorvastatin employing an experimental design approach
Macedonian Journal of Chemistry and Chemical Engineering, 2018 This study involved the optimization of experimental conditions for the forced degradation of atorvastatin employing the experimental design (DoE) approach, as a scientific multifactorial strategy.
Maja Hadzieva Gigovska +7 more
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