Analysis of PVC plasticizers in medical devices and infused
Plasticizers used to validate our GC–MS method were (CAS number, purity): Benzyl-Butyl Phthalate (BBP) as internal standard (85-68-7, 97%), DINP (68515-48-0, 99%), ATBC (77-90-7, 98%), DEHA (103-23-1, 99%), DEHT (6422-86-2, 96%), TOTM (3319-31-1, 99%), DEHP (117-81-7, 97%) from Sigma–Aldrich (Saint-Louis, USA) and DINCH (166,412-78-8, 99%) from
Analysis of PVC plasticizers in medical devices and infused
We therefore developed a versatile GC-MS method to identify and quantify both these newly used plasticizers and DEHP in MDs and to assess their migration abilities in simulant solution.
Analysis of PVC plasticizers in medical devices and infused
Analysis of PVC plasticizers in medical devices and infused solutions by GC-MS. Sign in | Create an account. https://orcid.org. Europe PMC. Menu
Establishing a protocol for the compatibilities of closed
Antineoplastic drugs were selected based on the following two criteria: (i) commonly used chemotherapy drugs, classified by their mechanism of action and (ii) drugs that pose potential incompatibility risks.
Phthalate and alternative plasticizers in indwelling medical
Analysis of PVC plasticizers in medical devices and infused solutions by GC-MS. Bourdeaux D, Yessaad M, Chennell P, Larbre V, Eljezi T, Bernard L, Sautou V; ARMED study group. Bourdeaux D, et al. J Pharm Biomed Anal. 2016 Jan 25;118:206-213. doi: 10.1016/j.jpba.2015.10.034.
- How are plasticizers analyzed in PVC tubings?
- Chromatographic analyses of both the plasticizers in the PVC tubings after solvent extraction (before migration tests) and in the simulant after contact with the samples (specific migration) were performed according to the analytical method described by Bernard et al. (2015).
- Does plasticizer release a PVC MD into a simulant solution?
- We then tested the developed method on 32 PVC MDs used in our hospital and evaluated the plasticizer release from a PVC MD into a simulant solution during a 24 h migration test. The results showed a predominance of TOTM in PVC MDs accompanied by DEHP (<0.1% w/w), DEHT, and sometimes DEHA.
- What are the alternative plasticizers for PVC MDS?
- This resulted in the commercialization of PVC MDs plasticized with the DEHP alternative plasticizers tri-octyl trimellitate (TOTM), di- (2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), di- (2-ethylhexy) adipate (DEHA), and Acetyl tri- n -butyl citrate (ATBC).
- How many plasticizers are found in medical devices analyzed?
- Distribution of the majority plasticizers in the 32 medical devices analyzed according to the type of MD. Moreover, in the MDs tested, trace levels of minority plasticizers are often found. Table 5 shows the quantities of the different plasticizers recovered from the MDs. Table 5. Plasticizer content of the 31 MDs analyzed.
- How do we quantify plasticizers in MDS?
- To quantify plasticizers in MDs, we performed a chloroform-based solvent extraction method suitable for extracting plasticizers in the MD’s matrix, as previously described by Bernard et al. .
- Can plasticizers be quantified in medical devices?
- For plasticizer quantification in MDs we chose to limit the sample quantity considering that the limit of quantification obtained on 10 mg was enough. Indeed we wanted to be able to analyze very small PVC samples from medical devices, so the less we used for extraction, the better. 3.4. Medical device tests