Valise changed their business model and no longer does testing for consumers. They were great because they were specifically focused on testing pharmaceuticals for contaminants so they were set up for this and new exactly what to look for. I don’t know of any other labs that do anything specific like this. There are many analytical testing labs out there in all the major metro areas, but when when I’ve tried to find one in the past they tend to be pretty expensive, like $700 to $1,000 for a compound analysis via HPLC, but that was a few years ago last time I looked. Perhaps there are new ones offering low cost services now.
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Some good news on the Indian pharmaceutical front… I wonder if they will be allowed to do unannounced inspections of the Indian factories. That was one of the problems cited in the Katherine Eban book, that the FDA was not allowed to do unannounced inspections of the facilities so some of the Indian companies were just hiding the false records, etc. before the FDA people inspected the factories…
US FDA to boost inspections of drug manufacturing units in India
Feb 27 (Reuters) - The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, a top executive for the Food and Drug Administration (FDA) told Reuters.
The FDA conducted more than 200 inspections in 2023 in India, picking up after a lull in unannounced inspections during the pandemic.
“We are putting every effort into increasing the number of inspections … (and) requesting more drug investigators to be stationed here,” FDA Country Director (India) Sarah McMullen said on Tuesday.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-boost-inspections-drug-manufacturing-units-india-2024-02-27/
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I want to provide two sources of medication testing that I haven’t seen on this forum.
This past weekend, I reached out to the labs below about whether they were able to test Indian generics (or any medication) for identity, quantity, and purity. The three medications I asked about, not quite randomly, were rapamycin, bempedoic acid, and dapagliflozin.
One of these labs has been very popular in the AAS (steroid) and peptide worlds for many years. Though they test substances that are controlled in the United States, they operate legally in their country (Czech Republic). Their owner is a former MD and is very active and professional on forums.
Janoshik Analytical
The quotes:
1x Rapamycin analysis x 380 USD = 380 USD
1x Bempedoic analysis x 380 USD = 380 USD
1x Dapagliflozin analysis x 380 USD = 380 USD
The 2nd lab is Chromate. Chromate is a fairly new company located in the US, but I have seen a sample report that matched a Janoshik test of the same batch of peptides very closely. I suspect their prices will increase if they gain in popularity.
The owner gave me permission to post his response:
“Those 3 items can be tested for $200 each. Purity can only be assessed if raw powder is provided. If the medications are in finished dosage form, then we can determine the amount of the compound in the capsule / tablet.”
I think I would be satisfied with knowing identity and content.
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GoodRap
#47
I’m Wayne from Germany. I’ve been reading a lot on this excellent forum (kudos and thanks esp. to the RapAdmin) and this is my first post, so hi.
The Valisure test report for the Zydus Cadilla sirolimus lists several ingredients in addition to sirolimus. One of them is octadecanedioic acid, described in Extending Nontargeted Discovery of Environmental Chemical Exposures during Pregnancy and Their Association with Pregnancy Complications—A Cross-Sectional Study - PMC as an “abnormal fatty acid also used in plastic and resin manufacturing” and described here as potentially toxic: https://doi.org/10.1042/bj2760569. I don’t know if we should be concerned with octadecanedioic acid at the apparently low concentrations detected by LC, with the caveat that the method only detects what is soluble in methanol (see the Valisure report), which may underestimate some contaminants, including octadecanedioic acid. On the other hand, there was very low confidence (low “library score”) that this ingredient (contaminant?) actually is octadecanedioic acid. If it is not, it could be something more benign or more toxic.
The low confidence about Agistatin E concerns me even more. Agistatin E is a mycotoxin from a filamentous fungi and is bioactive (cholesterol lowering) in humans. It wouldn’t be toxic at these levels, AFAIK, if that is what it is. One can hope that the library score for agistatin E and octadecanedioic acid were low because their concentrations are near the limit of detection of the methods used. More concerning is if the score for Agistatin E is low because it is another, potentially unhealthful, fungal toxin that is not in their scoring library.
An easy way to try to gain more confidence in the Zydus sirolimus product would be to contact Zydus and to ask them to confirm that these are indeed intended excipients or that these ingredients are known and conform to their own product analyses. E.g., they may be known “contaminants” based on their manufacturing reagents or based on what else is manufactured at the plant where they make sirolimus, if their plant isn’t cGMP. They should make a statement about any contaminants that don’t fall under these categories (potential fungal contamination?).
I won’t follow up on this myself, since I would rather take Rapamune. I’m posting this in case someone else on this forum might be interested.
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GoodRap
#48
He may have worded that poorly. It seems more likely that he meant: “Only purity can be” assessed if raw powder is provided. If the medications are in finished dosage form, then we can [additionally] determine the amount of the compound in the capsule / tablet.”
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Yes, English is not his first language.
