Chromatography Forum

First i would start with compare some of this 7k$ medication with nystatin from China producers.

The problem is that manufacturers add different kinds of inactive ingredients before they pack medications into capsules and tablets, and those inactive ingredients change appearance and smell. But my medication is supposed to be 99% pure, without any added ingredients.

This paper describes an analysis that would tell you what percent of your powder actually is nystatin:

J AOAC Int. 2001 Jul-Aug;84(4):1050-5.
Liquid chromatographic determination of nystatin in pharmaceutical preparations.
Wilson P, Stewart A, Flournoy V, Zito SW, Vancura A.
Source

US Food and Drug Administration, NRL, Jamaica, NY 11433, USA.
Abstract

A rapid, reversed-phase liquid chromatographic method was developed for the assay of nystatin in the bulk drug and a variety of dosage forms. Analysis was performed on a Symmetry C18 reversed-phase column using a mobile phase of methanol-water-dimethylformamide (DMF; 55 + 30 + 15, v/v/v), with detection by UV at 305 nm. Quantitation is based on the sum of the peak areas of the 2 major isomers of nystatin. The linearity of the assay was determined for a concentration range of 0.05 to 0.2 mg/mL (correlation coefficient > 0.999). Accuracies and precision showed good reproducibility.

The instrument used runs about $30-60K, but is a fairly common piece of analytical equipment. However, this analysis won't tell you if there is bacterial or other types of trace toxic contamination (think current outbreak of fungal meningitis in the U.S.), or if the crystalline form is correct to allow the drug to dissolve in your stomach and be effective, or any of a number of other tests usually run to assure a product is ready for the market. These are really good reasons to buy your drugs from a reputable and regulated source.

Thank you very much Mary, this is great. Could you please give me a link to this text? I’d like to include the link when I contact a laboratory. This way they’ll immediately know exactly what I want.

And yes, I’m aware it’s risky what I’m doing. I’m not taking it lightly, believe me. I have a chronic illness and I’m aware how precious health is. Me and my friends used to buy weed and other stuff from dealers. Today I wouldn’t dare doing that. Not because I think weed itself is dangerous, but because I’m concerned it would be contaminated by something toxic. If I could buy nystatin from a pharmacy I would. But I simply can’t afford it because I’m physically handicapped due to my illness and therefore unable to hold a job.

I can't echo this enough. From what you have said it seems as if the Chinese supplier is selling to you the raw material as though you are a manufacturer, not an individual. Every manufacturer is expected to do the tests that Mary has listed and insure that the material is of good quality. In addition, if you are getting raw material grade, you would then have to compound a mixture to replicate the capsules/tablets you previously received. You would have to make sure you had adequate mixing, that the mixture you made gave you the same efficacy when taken, that you were handling the materials in a sterile manner, including storage and whatever vessels you used to compound.

The suppliers from China also test the medications themselves. Certificate of Analysis includes 7 different things (Appearance, Assay(HPLC), Heavy metals, Solubility, PH, Ash, Loss on drying). But of course the problem is that you can’t be sure whether they’ve really done all those tests.

Nystatin capsules that I used to take contained 500.000 units. I know that is equivalent to about 114 mg of nystatin. Packing it into capsules is not a problem since I have different size manual capsule fillers, the kind they use in pharmacies. I can also control the amount of nystatin in each capsule by adding the right amount of vitamin C or any other filler into the mix. I packed the powder into small amber glass bottles and sealed them with special sealing wax which will prevent moisture from entering the bottles. But just to be sure I also put bottles into Lock & Lock airtight containers with activated Drierite desiccant and a humidity card which will let me see whether there’s any moisture getting into the container. This nystatin will be good for 100 years. LOL

The team i work within recently developed a new method for the analysis of Nystatin for HPLC as it was previously only tested using a 'micro' technique. I can tell you the method isn't the simpliest i have seen as the nystatin usually splits as two distinct isomers. I don't think you are going to find anywhere that can test this product purity for you cheaply, not in such small quantities anyway.
Taking on the challenge of buying a HPLC/GC or whatever instrument would also be wayy to costly, and you would struggle to get any meaningful results without a trained operator.

The team i work within recently developed a new method for the analysis of Nystatin for HPLC as it was previously only tested using a 'micro' technique. I can tell you the method isn't the simpliest i have seen as the nystatin usually splits as two distinct isomers. I don't think you are going to find anywhere that can test this product purity for you cheaply, not in such small quantities anyway.
Taking on the challenge of buying a HPLC/GC or whatever instrument would also be wayy to costly, and you would struggle to get any meaningful results without a trained operator.

Thanks for your post LC_addict. Could you please tell me how much do you think is an acceptable price for nystatin purity testing? Could your laboratory do the test? Thank you very much.