izpis_h1_title_alt

Fizikalno-kemijsko preskušanje izbranih plastičnih ovojnin in materialov po USP 661.2 in 661.3.
Zorko, Zala (Author), Časar, Zdenko (Mentor) More about this mentor... This link opens in a new window

.pdfPDF - Presentation file, Download (2,93 MB)

Abstract
Plastične materiale, ki se uporabljajo za plastično ovojnino ali plastične proizvodne dele, sestavljajo polimeri z različnimi molekulskimi masami in različni dodatki, kot so antioksidanti, stabilizatorji, drsila, plastifikatorji in barvila. Različne snovi lahko fizikalno-kemijsko interagirajo s plastično ovojnino ali plastičnimi proizvodnimi deli, posledica pa je lahko nakopičenje izlužkov v snoveh, ki so v kontaktu z ovojnino. Zato je pomembno, da izberemo materiale, ki so kakovostni, varni in učinkoviti. Cilj magistrske naloge je bil ugotoviti varnost in kakovost izbranih plastičnih ovojnin in plastičnih proizvodnih delov z različnimi fizikalno-kemijskimi preskušanji glede na podpoglavji <661.2> in <661.3> ameriške farmakopeje. Glede na ti podpoglavji smo na sedmih izbranih vzorcih izvedli preskušanje izgleda ekstrakcijske raztopine barve in bistrosti, preskus kislosti oziroma bazičnosti, na UV-VIS spektrofotometru smo v spektru med 230 in 360 nm določili absorbanco ekstrakcijske raztopine vzorca, prav tako smo ekstrakcijski raztopini vzorca določili celotni organski ogljik (TOC). Po končanem preskušanju smo ugotovili, da vse ekstrakcijske raztopine vzorcev ustrezajo specifikacijskim mejam v obeh navedenih podpoglavjih ameriške farmakopeje, saj so bile vse ekstrakcijske raztopine vzorcev brezbarvne in bistre, absorbanca vseh ekstrakcijskih raztopin vzorcev je bila nižja od 0,2, razlika med TOC slepe kontrole in ekstrakcijskih raztopin vzorca je bila manjša od 5 mg/L (specifikacija podpoglavja <661.3>) oziroma 8 mg/L (specifikacija podpoglavja <661.2>). Na podlagi rezultatov lahko zaključimo, da so vzorci testiranih plastičnih ovojnin in materialov varni in kakovostni.

Language:Slovenian
Keywords:izgled raztopin, absorbanca, TOC, plastična ovojnina, plastični proizvodni deli, podpoglavje <661.2> ameriške farmakopeje, podpoglavje <661.3> ameriške farmakopeje, fizikalno-kemijsko preskušanje
Work type:Master's thesis/paper (mb22)
Organization:FFA - Faculty of Pharmacy
Year:2019
Views:371
Downloads:157
Metadata:XML RDF-CHPDL DC-XML DC-RDF
 
Average score:(0 votes)
Your score:Voting is allowed only to logged in users.
:
Share:AddThis
AddThis uses cookies that require your consent. Edit consent...

Secondary language

Language:English
Title:Physicochemical testing of selected plastic packaging systems and materials according to USP 661.2 in 661.3.
Abstract:
Plastic materials used for plastic packaging systems and plastic packaging systems used for manufacturing pharmaceutical products consist of polimers with different molecular masses and different additives such as antioxidants, stabilizators, lubricants, plastificators and colourants. Different substances can physicochemically interact with plastic packaging systems for pharmaceutical use or plastic packaging systems used for manufacturing pharmaceutical products. This can cause accumulation of leachables in components that are in contact with plastic packaging system. Due to this interaction, it is important to choose quality, safe and efficient materials. Aim of the master thesis was to ensure safety and quality of chosen plastic packaging systems for pharmaceutical use and plastic packaging systems used for manufacturing pharmaceutical products with different physicochemical tests according to subchapters of USP <661.2> and <661.3>. According to the abovementioned subchapters, we performed testing on seven samples. We did tests of appearance of solution’s colour and clarity on extraction solutions of samples, we tested acidity or alkalinity, we measured absorbance on UV-VIS spectrofotometer in the spectrum between 230 and 360 nm, we also measured total organic carbon (TOC). After all the tests, the results corresponded to the specifications in USP subchapters <661.2> and <661.3>. All extraction solutions were colourless and clear, absorbances of all the extraction solutions of all samples were under 0,2, differrence between TOC of the blank solution and TOC of the extraction solutions of all samples were lower than 5 mg/mL (according to specification in subchapter <661.3>) or lower than 8 mg/L (according to specification in subchapter <661.2>). We can therefore conclude that the exctraction solutions of all tested samples of plastic packaging systems for pharmaceutical use and plastic packaging systems used for manufacturing of pharmaceutical products are safe and have good quality.

Keywords:appearance of solution, absorbance, TOC, plastic packaging systems for pharmaceutical use, plastic packaging systems used for manufacturing pharmaceutical products, USP <661.2>, USP <661.3>, physicochemical testing

Similar documents

Similar works from RUL:
Similar works from other Slovenian collections:

Comments

Leave comment

You have to log in to leave a comment.

Comments (0)
0 - 0 / 0
 
There are no comments!

Back