Thank you so much for ordering the test and having the sample checked.
Very interesting. I wonder if previous testing was actually recovering the endotoxin from oil matrix properly or we had a bunch of false negative results up until now.
Pharma Test cyp C of A shows limit NMT 0.88 EU/mg.
503b compounder sets even higher.
Great that you have a calibrated endotoxin test for oils now
@janoshik. I know IP is a concern but were you able to show close to 100% recovery with your in house method?
Thanks to your help we are getting closer to the real story. We need to confirm absolute or relative specs with respect to pharma testing vs Jano's method.
Well done!
For reference:
Compounding pharmacy
You can compare against the big pharma COA in the Source QC thread. The big pharma one much more exhaustive. To your point
@B Ware the compounding pharmacies may share raws suppliers with some UGL vendors. It's a great question.
B Ware's
HPLC test on same product (different batch).
Pharma
Could add in a few positive controls with pharma or compounded pharma products although the absolute concentration of impurities will be lower than in the raws obviously.
Ok, I am going to start with the simplest example I could think of that may be of interest to members. Getting a C of A from Pharma isn't as easy as it used to be. This took a little work with persistence. I have sanitized some of the details from this one to protect manufacturer confidential information as per forum Terms and Rules.
This is an FDA approved Testosterone Cypionate product manufactured in...