Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)

Abstract Background The intolerance to Acetylsalicylic Acid (ASA) can be detected by conducting oral provocation testing (OPT), which is to gradually introduce low doses of ASA. To perform this test, hospital pharmacies compound small batches of different low-dosage ASA capsules. This work aims to validate a method for fast HPLC-UV assay that allows routine quality control and physicochemical stability studies of capsules. Methods The chromatographic separation is performed using a C18 column Kinetex (100 A, 50×4.6 mm, 2.6 µm) equipped with a precolumn C18. Separation is achieved using a mobile phase composed of water-acetonitrile-orthophosphoric acid (68:32:0.2 v/v/v) at a flow rate of 0.8 mL/min and UV detection at 237 nm. Results Validation shows that the method was suitable for routine analysis and could be used to perform stability studies. Conclusions The 5, 25, 100 and 250 mg dosed capsules show acceptable stability over 12 months, while the 1 mg dosed capsule show an unacceptable degradation of more than 15 % after 3 months. Therefore, hospital pharmacy can plan the manufacture of capsules and anticipate the requests of doctors.

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Fully-Automated Synthesis of 177Lu Labelled FAPI Derivatives On The Module Modular Lab-Eazy

10.21203/rs.3.rs-292849/v1 ◽

2021 ◽

Author(s):

Kurtulus Eryilmaz ◽

Benan KILBAS

Keyword(s):

Quality Control ◽

Chromatographic Analysis ◽

Radiochemical Purity ◽

Radiochemical Yield ◽

Automated System ◽

Automated Synthesis ◽

Modular Approach ◽

Stability Studies ◽

European Pharmacopoeia ◽

First Time

Abstract Backround: To the best of our knowledge, manually production of [177Lu]Lu-FAPI radiopharmaceutical derivatives has been only described in literature. In this work, a fully-automated [177Lu]Lu-FAPI synthesis has been well designed for the first time using commercially available synthesis module. In addition to the development of an automated system with disposable cassette, quality control (QC) and stability studies were comprehensively employed. Results A fully automated synthesis of [177Lu]Lu-FAPI derivatives was achieved on the Modular Lab Eazy (ML Eazy) with high radiochemical yield (85–90%). Chromatographic analysis indicated the formation of radiosynthesis with an absolute radiochemical purity (99%). Stability experiments clarified the durability of the products within 4 days. All obtained specifications are consistent to European Pharmacopoeia. Conclusion A fully automated synthesis of [177Lu]Lu-FAPI radiopharmaceuticals were accomplished regarding quality control standards and quality assurance by using commercially available a modular approach namely ML Eazy with disposable customized cassette and template.

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Development of a Rapid and Sensitive HPLC Assay Method for Lenalidomide Capsules and Its Related Substances

E-Journal of Chemistry ◽

10.1155/2012/673736 ◽

2012 ◽

Vol 9 (3) ◽

pp. 1165-1174 ◽

Cited By ~ 4

Author(s):

L. Maheshwara Reddy ◽

K. Janardhan Reddy ◽

L. Bhaskar Reddy ◽

P. Raveendra Reddy

Keyword(s):

Wave Length ◽

Hplc Method ◽

Assay Method ◽

Hplc Assay ◽

Stability Studies ◽

Related Substances ◽

Mobile Phases ◽

Acid Sodium Salt ◽

Sun Light

A chromatographic method was established for the determination of lenalidomide and related substances in 10 mg and 5 mg capsules using Sunfire C-18(250×4.6 mm ID, 5 μm) HPCL column with 85:15 v/v ratio of mobile phases A (mixture of phosphoric acid buffer and 1-octane sulphonic acid sodium salt) and B(55: 45 v/v ratio of methanol and acetonitrile) at 40°C and 210 nm wave length. The degradation studies were performed using 0.1N HCl, 0.1 N NaOH, 1% v/v hydrogen peroxide, humidity, UV at 254 nm, Sun light, and heat to 60°C. No significant degradation of lenalidomide was observed. However, the slight degradation was observed in presence of NaOH. The developed HPLC method gave the peaks purity angle was less their threshold angle, indicating it to be suitable for stability studies. It was validated with respect to linearity, accuracy, precision, ruggedness, and robustness.

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A convenient assay method for the quality control of peptides and proteins

Journal of Pharmaceutical Sciences ◽

10.1021/js990209e ◽

1999 ◽

Vol 88 (12) ◽

pp. 1242-1248 ◽

Cited By ~ 2

Author(s):

Neil Purdie ◽

Dennis W. Province ◽

Erin A. Johnson

Keyword(s):

Quality Control ◽

Assay Method

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Influence of Packaging and Stability Test Assessment of an Anti-aging Cosmetic Cream

Materiale Plastice ◽

10.37358/mp.18.3.5043 ◽

2018 ◽

Vol 55 (3) ◽

pp. 426-430

Author(s):

Anca Maria Juncan ◽

Luca Liviu Rus

Keyword(s):

Quality Control ◽

Stability Test ◽

Stability Studies ◽

Stability Tests ◽

Cosmetic Product ◽

Accelerated Stability ◽

Test Assessment ◽

Cosmetic Formulation ◽

Plastic Containers

The aim of this study was the development and formulating of a cosmetic product and the assessment of compatibility tests performed on the product, transfered to the cosmetic jar. Sample of cosmetic cream were stored using 50 mL PP (Polypropylene) plastic containers. The developed cosmetic formulation was monitored under accelerated stability studies. Accelerated stability tests were performed over a period of 30 days while maintaining the product at 4, 20 and 40�C. Quality control initial, and after initiating the accelerated stability test was performed for the developed cosmetic formulation.

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Primary Packaging and Stability Evaluation of a Serum Used for the Periorbital Area of the Sensitive Eye

Materiale Plastice ◽

10.37358/mp.19.2.5186 ◽

2019 ◽

Vol 56 (2) ◽

pp. 360-365

Author(s):

Andrei Catalin Muntean ◽

Anca Maria Juncan ◽

Dana Georgiana Moisa ◽

Andreea Loredana Vonica ◽

Luca Liviu Rus ◽

...

Keyword(s):

Quality Control ◽

Hyaluronic Acid ◽

Stability Test ◽

Stability Evaluation ◽

Stability Studies ◽

Stability Tests ◽

Cosmetic Product ◽

Accelerated Stability ◽

Cosmetic Formulation ◽

Glass Bottles

The aim of this study was the development and formulating of an eye contour serum containing hyaluronic acid (HA) and the assessment of stability tests performed for the cosmetic product, transfered into a glass cosmetic bottle with polipropylene (PP) pump and cap. Sample of cosmetic serum were stored using 20 mL glass bottles with PP (Polypropylene) pump and cap. The developed cosmetic formulation was monitored under accelerated stability studies, performed over a period of 30 days while maintaining the product at 4, 20 and 40�C. Quality control initial, and after initiating the accelerated stability test was performed for the developed cosmetic formulation.

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