Extractables and Leachables Analysis

Dear All,

I need to analyse the samples contain the Polymer(plastics) Extractables, Leachables in the Pharmaceutical analysis rightnow i know that its conc is about 5 to 50 mg in 1000ml of solution basing on their physical properties which colums need to use and which detector can able to detect its presence in water, ethanol, 50%DMF is it possible to analyse by PDA detector.

A link that can help you

http://www.polymersolutions.com/leachables.html

efoconnor is correct.  You need to identify specific extractable components and then search for analytical methods.  There are many ways to complete the extraction, and many options for analysis.

In general, you will need extraction equipment (Soxhlet or other glassware, sample homogenization equipment, solvent evaporation methods, etc.).  For analysis, HPLC is common, but some methods use FTIR or NMR for organics, or ICP-MS for metals.

Start with standard references sources (USP, European Pharmcopeia) and then post some more questions here.

Hi efoconner, Hello Dr.,

As you told we need to find out the analyte of intrest properties, that may be my question now i am analysing by NVR qty, FTIR to get the information about the composition of Extractables but i wanted to do the more elabarated analysis by chromatography.

Normally i get the extractables from MOC of devices (like Pharmacetical grade Plastics) we can idetify by FTIR is it possible to idetify the Plastics with PDA or UV-Vis detector, if yes what type of columns require to get the seperation in these typeo of molecules present in those samples,

we got the clear information through GC-MS and other techniques that there is no metals from the devices as it is not there in MOC

I will get back you with further analysis and work.

Thank you, yes GCMS usase in analysis of Extractables, leachables study this information is usefull but i wanted to know weather i can analyse it by LC with PDA detector

My organization currently performs the analytical side for an international organization specializing in the verification of drinking water units for extractable (sometimes called leachable) components from the units manufacture.

Depending upon your application there are a number of NSF protocols to follow for the extraction. For drinking water, you are generating synthetic drinking water, challenging the system, and then analyzing the water from the challenge. If your application is within the midical industry, then you should look at adjusting the extraction fluid from synthetic drinking water to whatever fluid the unit will be used with.

On the analytical side doe oeganics you typically you use GCMS, both volatiles and semivolatiles by GCMS (USEPA methods 524.2, 525, and 625) as well as at time HPLC when the known chemistry of the material would indicate the potential for compounds to leach from the unit that are not ameniable to GCMS. For metals we are using ICPMS following USEPA method 200.8. The challenge is first to get a complete breakdown of the material the unit is made up of (100.0% composition of parts in contact with the fluid) so you know what to look for. This is typically a fairly arduous process to simply sort out everything that went into the unit. This list is then sent over to a toxicologist who then determines if any additional testing is needed beyond the GCMS and ICPMS techniques. 

On the instrument side, if this is in fact NSF type testing, there is a significant challenge in achieving the levels of detection for their requirement (NSF).

If this is pharnaceutlcal; I would be surprised if there are not very specific requirements for the for how the leaching is performed, and what analytes you need to monitor.