what you don't understand? that raw manufacturer can create pure product if they want and they care?
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Janoshik Analytical laboratory testing services
- Thread starter janoshik
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readalot
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That a "random" sample used for this particular work would test as clean as the euro pharmacopeia ref standard. As I said, not a hint of anything besides side product. No free hormone. No precursor. Nothing. Look at the GCMS raw data.
IMO: All the data we have thus far indicates HPLC overestimates purity of Test ester raws with -ene impurities due to the inability of the HPLC method to resolve the respective peaks.
See posts #219 and 220. Combined with data shared above by Jano today (minimal side product formation in GC), the picture seems very clear to me.
Would be simple to demonstrate with testosterone impurity (-ene) reference standard mixed with test ester ref standard at various ratios. Then shoot onto HPLC.
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janoshik
Subscriber
We'we had exactly two test e raw samples in last week and the other was 30% purity, so I figured it wouldn't be quite representative.
And I didn't feel like scouring the archives.
Will run the CRM through HPLC tomorrow if we have the time.
And I didn't feel like scouring the archives.
Will run the CRM through HPLC tomorrow if we have the time.
readalot
Member
Thanks for the follow up. Sorry I am confused.
Just need the HPLC raw data for this, no? All that is shown in the raw data file is the GCMS data.
If someone is interested in all of this detail, I'll split the CRM for the testosterone -ene impurity now that Jano purchased this TE reference standard (CRM). That should get to the bottom of this issue.
I thought you already did:
Just need the HPLC raw data for this, no? All that is shown in the raw data file is the GCMS data.
If someone is interested in all of this detail, I'll split the CRM for the testosterone -ene impurity now that Jano purchased this TE reference standard (CRM). That should get to the bottom of this issue.
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Was the test C raw sample with more shit in it? Like ditotrestolone or something like that..I would have been more interested in seeing the pharmacopeia standards of test C ran against those test C RAWS, but my knowledge about all these stuff is very very poor so probably just talking shit
readalot
Member
Test E or Test C. Either one proves the same point. He is doing the CRM for Test E which is great.
See my extensive comments above. The Test C and Test E raw I had my collaborator send in appears to have been significantly contaminated with impurity the HPLC may show as Test C / Test E. The HPLC results on both of those raws showed high purity. The GCMS data indicates otherwise. That's what we are trying to trying to figure out (Project 3).
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janoshik
Subscriber
I'd love to rerun it personally under my specified conditions.
European Pharmacopoeia, which is the one I have full access to doesn't use Testosterone Cypionate, so I cannot have that delivered to me with fully iced logistics and guarantees that I can sue for. I looked elsewhere too, but it's not quite easy to obtain such a standard, unfortunately.
readalot
Member
Fantastic! My offer stands if anyone wants to put some skin in the game. And if not I guess I'll pay for the other CRM (for the -ene impurity) myself if Jano agrees to the testing.
Thank you Jano. These are exciting tests and appreciate your work and collaboration.
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janoshik
Subscriber
My pleasure.
Although I am not entirely sure what exactly you mean by the first paragraph?
Is there CRM for that particular impurity available?
Thank you.
readalot
Member
I thought there were a bunch of variants (minus two protons) we could choose from that had CRM status. I or you would have to confirm availability for your location.
janoshik
Subscriber
There's exactly one available. 'H'
And it's something entirely different.
And it's something entirely different.
readalot
Member
Infamous impurity F not available? Bummer!
Thanks for checking. It's all riding on your personally specified conditions now.
janoshik
Subscriber
Not at European Directorate for the Quality of Medicines.
readalot
Member
Also these you shared I'd have to match up with "Impurity X descriptors". But as you say we are limited by what you can get ahold of.His feedback was that the GC peak in question was one of these Test Cyp derivatives missing a hydrogen.
As I stated before, we'd need usp standards to do a definitive targeted analysis with gcms
Fun collaborating with you. Thanks.
janoshik
Subscriber
readalot
Member
Thank very much for updating the data file. I could write many more paragraphs but seems only you and I have any interest in this. Further comment / speculation on my part is pointless without the CRM for impurity to test with HPLC in various dilutions with API CRM.
I really appreciate you attempting to quantify the amount of impurity generated from CRM Test E with your GCMS assay.
In my mind still unclear if the impurity found in Project 3 is actually there in the raw or was reaction artifact in the GC. Perhaps trace amount of catalyst in the raw amplified the generation of impurity in the GC vs the CRM. ??? Would need additional work.
Thank you Janoshik. You work is commendable here. I appreciate you.
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