Cyclophosphamide - problems during reconstitution, please help

[lager]

Hello everybody

I do not know if this question is asked in a right place, but I really do not know where I can seek help.

The problem is that when a pharmacist reconstitutes cyclophosphamide (using a closed-system transfer device - CSTD), insoluble particles appear in the syringe.
These particles are not an insoluble drug. They look like a kind of rubber stopper (from a vial). This situation only takes place during reconstitution of cyclophosphamid.
The drug manufacturer claims that the possible cause is the presence of ABS in a closed transfer system. However, the CSTD manufacturer claims that, of course, ABS is present in the system, but it has no contact with the drug.
Thus, my question is : Have you ever met or heard of similar situation?
If not, maybe could you advise me where can I look for a help ?

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[lord999]

Ok, this should be simple enough. Transfer the particles as neatly as you can to a container, and acetonitrile or styrene should stick out like a sore thumb if you have a mass-spectrometer in the lab or in the pharmacy. But can't you tell ABS from looking? ABS is a pretty obvious off-white color. If it's not, you might want to just pack it and send it back to the manufacturer for USP testing.

Sigh, they don't teach analytic chemistry in pharmacy anymore...

 

[lager]

Thank you for quick answer.

Well, I'm not a pharmacists, I work for company that distributes medical products.
I tried to send the product back to the manufacturer but the manufacturer claims that if the product is contaminated, it is not possible to test contaminated samples : ( and in this case I was forced to look for solution myself. ]

 

[CetiAlphaFive]

Ok, this should be simple enough. Transfer the particles as neatly as you can to a container, and acetonitrile or styrene should stick out like a sore thumb if you have a mass-spectrometer in the lab or in the pharmacy. But can't you tell ABS from looking? ABS is a pretty obvious off-white color. If it's not, you might want to just pack it and send it back to the manufacturer for USP testing.
Sigh, they don't teach analytic chemistry in pharmacy anymore...

If they were going to trash the syringe anyway, I'd try to eject the liquid but leave the particles.

Then, draw up a bunch of acetone.
If it dissolves- voila.