13 Assay and stability testing

Wong, Anissa W.; Datla, Aruna

doi:10.1016/s0149-6395(05)80057-1

Cited by 6 publications

(4 citation statements)

References 4 publications

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“…7 From the data obtained in these studies it is easier to determine ideal storage conditions and re-test periods, as well as establishing shelf lives. 8 Moreover, stress testing allows the determination of the inherent stability of a molecule when subjected to adverse conditions by establishing the degradation pathways which is analogous to the established metabolic profile.…”

Section: 6mentioning

confidence: 99%

“…5,6 Stability-indicating methods for drugs are established and studied in order to provide evidence on the quality of drugs when exposed to different conditions such as pH, temperature, solvent system composition, solution ionic strength, and light. 7 From the data obtained in these studies it is easier to determine ideal storage conditions and re-test periods, as well as establishing shelf lives. 8 Moreover, stress testing allows the determination of the inherent stability of a molecule when subjected to adverse conditions by establishing the degradation pathways which is analogous to the established metabolic profile.…”

Section: Introductionmentioning

confidence: 99%

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Stability-indicating methods for the enantioselective determination of dihydropyridines by high performance liquid chromatography and capillary electrophoresis

et al. 2012

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2012Stability-indicating methods for the enantioselective determination of dihydropyridines by high performance liquid chromatography and capillary electrophoresis ANALYTICAL METHODS, CAMBRIDGE, v. 4, n. 9, supl. 2, Part 3, pp. 2953-2961, SEP, 2012 This paper presents simple, rapid, precise and accurate stability-indicating HPLC and CE methods, which were developed and validated for the determination of nitrendipine, nimodipine and nisoldipine. These drugs are calcium channel antagonists of the 1,4-dihydropyridine type which are used in the treatment of cardiovascular diseases. Experimental results showed a good linear correlation between the area and the concentration of drugs covering a relatively large domain of concentration in all cases. The linearity of the analytical procedures was in the range of 2.0-120.0 mg mL À1 for nitrendipine, 1.0-100.0 mg mL À1 for nimodipine and 100.0-600.0 mg mL À1 for nisoldipine, the regression determination coefficient being higher than 0.99 in all cases. The proposed methods were found to have good precision and accuracy. The chemical stability of these drugs was determined under various conditions and the methods have shown adequate separation for their enantiomers and degradation products. In addition, degradation products produced as a result of stress studies did not interfere with the detection of the drugs' enantiomers and the assays can thus be considered stability-indicating.

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Section: 6mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability-indicating methods for the enantioselective determination of dihydropyridines by high performance liquid chromatography and capillary electrophoresis

et al. 2012

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“…The half-life of the radioactive component and the stability of certain radiopharmaceuticals are the main constraints of its SC. Indeed, for medicine in general, stability refers to the product's capacity to preserve its active component during a certain time despite variation its environmental factors [3]. When it comes to radiopharmaceuticals, the radioactive component reduces the stability of the medical component.…”

Section: Introductionmentioning

confidence: 99%

Technetium-99 process mapping: an end-to-end SCOR and BPMN modelling

Rabarijaona¹,

Ndiaye²

2022

2022 IEEE 6th International Conference on Logistics Operations Management (GOL)

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The supply chain of Molybdenum-99 (Mo-99) or more precisely, its daughter product, Technetium-99 (Tc-99m), is widely acknowledged as complex by both practitioners and researchers. This product is used to diagnose some of the deadliest diseases and loses its active substance over time. Furthermore, its supply chain (SC) is highly regulated because by nature it is a pharmaceutical and a radioactive product at the same time. The complexity of the SC is also due to the fact that said SC was not initially designed for the Tc-99m. In parallel, different production technologies are being investigated, which adds more to the diversity of the Tc-99m SC landscape which consequently can vary tremendously. In this context, this study aims at implementing a model that would clearly distinguish the roles and activities of the major stakeholders in the most prevalent Tc-99m SC: a reactor-based SC, from the production of the raw materials to the patient examination. Furthermore, this perspective will ultimately lead to the optimization of the SC and to reach that goal, the establishment of an end-to-end supply chain mapping as comprehensive as possible is the first step toward to be achieved. The originality of this study lies in the detailed modeling of the activities of the key actors of the Tc-99m chain based on the Supply Chain Operations Reference (SCOR) reference and the Business Process Modelling Notation (BPMN) standard. A presentation of other production routes using different technologies completes this study to give a perspective as broad as possible of the different Tc-99m SC design.

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“…Stability of an active compound refers to the extent to which the product retains its original properties and characteristics from the time of manufacture [12]. Extemporaneously prepared oral liquids often have arbitrary short expiry dates [13], with little or no information available on the compounded inhalation solutions.…”

Section: Introductionmentioning

confidence: 99%

An Investigation into the Stability and Sterility of Citric Acid Solutions Used for Cough Reflex Testing

Falconer

Lau

et al. 2014

Dysphagia

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Citric acid is used in cough reflex testing in clinical and research settings to assess reflexive cough in patients at risk of swallowing disorders. To address a lack of knowledge in this area, this study investigated the stability and sterility of citric acid solutions. Triplicate solutions of citric acid (0.8 M) in isotonic saline were stored at 4 ± 2 °C for up to 28 days and analysed by high-performance liquid chromatography. Microbiological sterility of freshly prepared samples and bulk samples previously used for 2 weeks within the hospital was determined using a pour plate technique. Microbial survival in citric acid was determined by inoculating Staphylococcus aureus, Escherichia coli, or Candida albicans into citric acid solution and monitoring the number of colony-forming units/mL over 40 min. Citric acid solutions remained stable at 4 °C for 28 days (98.4 ± 1.8 % remained). The freshly prepared and clinical samples tested were sterile. However, viability studies revealed that citric acid solution allows for the survival of C. albicans but not for S. aureus or E. coli. The microbial survival study showed that citric acid kills S. aureus and E. coli but has no marked effect on C. albicans after 40 min. Citric acid samples at 0.8 M remained stable over the 4-week testing period, with viable microbial cells absent from samples tested. However, C. albicans has the ability to survive in citric acid solution if inadvertently introduced in practice. For this reason, in clinical and research practice it is suggested to use single-use aliquots prepared aseptically which can be stored for up to 28 days at 4 °C.

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13 Assay and stability testing

Cited by 6 publications

References 4 publications

Stability-indicating methods for the enantioselective determination of dihydropyridines by high performance liquid chromatography and capillary electrophoresis

Stability-indicating methods for the enantioselective determination of dihydropyridines by high performance liquid chromatography and capillary electrophoresis

Technetium-99 process mapping: an end-to-end SCOR and BPMN modelling

An Investigation into the Stability and Sterility of Citric Acid Solutions Used for Cough Reflex Testing

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