Leachables and Extractables in pharmaceuticals

[pillin]

Hello,
i need some information about testmethods for the analysis of ectractables and leachables in pharmaceutical formulations by HPLC or GC. Examples for leachables are Dibutyl phtalate (DBPht), Bis-(2-ethyl hexyl) phtalate (DEHP, Dioctyl phtalate, DOP) and Butylated hydroxytoluene (BHT).
The origin of these leachables can be silicon tubing used for filling of liquid pharmaceutical formulations or primary packing materials like plastic vials.
Can anyone provide me some information about testmethods, specifications or companies that are capable to do this analysis in middle europe?

[Cathy]

I have a HPLC test method for those leachables.

Column: Agilent SB-CN, 4.6*150mm, 3.5um
Mobile A: 0.1% Formic Acid
Mobile B: 0.1% Formic Acid in 90% ACN, 10% Milli Q water
Flow Rate: 1mL/min
Column Temp: 40C
UV wavelength: 270 nm
Gradient: Time %B
0 10
36 100
45 100
46 10
post time: 5 min

Dibutyl Phthalate, DEHP and BHT can be eluted out with this method.

There is a good review about Extractable/Leachable.

"Extractable/Leachable Substances from Plastic Materials Used as Phahrmaceutical Product Containers/Devices"
Dennis Jenke, PDA Journal of Pharmaceutical Science and Technology, Vol 56, No. 6, 2002, pg 332-371

Hope those informations can help you.

[jamesque]

A clearing house for current information and industry best pratice for leachables and extractables is Product Quality Research Institute (PQRI). Check the following link for the lastest guidances.

http://www.pqri.org/pdfs/LE_Recommendat ... -29-06.pdf