The laboratory notebook: answering important questions about quality.
Q. I purchased a product called "arginine alpha keto glutarate" and had it tested by an analytical lab. The report came back showing the product had an arginine component and an alpha keto glutaric acid component. I thought the product was a single entity. Am I wrong?
A. You probably are. Recently we have seen an increasing number of novel compounds advertised in trade journals, and several have been submitted to our lab. In addition to the one you mentioned there are ornithine alpha keto glutarate and several carnitine combinations, to name just a few. The issue relates to the difference between a compound and a mixture.
A compound is a substance with a fixed ratio of two or more connected (bonded) molecular entities. Every sample of a given compound is identical. A mixture, on the other hand, is a combination of two or more molecular entities that are not connected and therefore do not have a fixed ratio. It is possible for samples of a mixture to vary wildly. While we have seen several of these products, to date we have not seen one that is a single compound; they have all been mixtures. Therefore, a proper analysis would indeed report two or more components, and not a single entity as you had expected.
This is an important point to understand when buying these products. Presumably the supplier is charging a premium for "synthetically modified" material since synthesis is expensive. If you are receiving a mixture you should not be paying that premium. How do you ensure you are getting what you pay for? The answer is simple; properly specify the product you want and then get it tested. And if you are indeed getting a "synthetically modified" compound, the next question you must ask is are these compounds appropriately sold as nutritional supplements.
Q. I received the analytical results of one of my products from my outside laboratory and I am very skeptical of its accuracy. The lab's response to my query was very unresponsive; in short they said they were the experts and their results were correct. Should I be satisfied with this response?
A. Absolutely not. If there is one recurring theme of this column over the years it is that analytical chemistry is a business and labs should behave as such, which includes providing satisfactory customer service. There is a notion at some labs that because analytical chemistry is a high science practiced by highly skilled professionals using remarkable technologies (all of which we hope is always true), clients, being mere mortals, should not be taken seriously. We believe this is outdated and inappropriate in today's commercial world. If you take someone's money you owe them service.
When a question about an analysis occurs in our lab we follow a three-step approach. First, without any hesitation and at our expense, we review the details of the analysis. This includes reviewing the raw data generated during the analysis, the calculations made from that data and the recording of the analytical results on the report issued to the client. We then send the supporting data to the client with an explanation.
At this first stage we also ask the client to submit whatever documentation they have indicating that the analysis may be incorrect. Many times that documentation does not conflict with the initial analysis; it is just different. It could result from a different analytical method that measured different components, a different lot having been tested or even a different formulation, all of which would explain the unexpected results. Our goal in all of this is to satisfy the client, and not just give an answer.
If after presentation of the supporting data the client still insists the analysis is wrong, we generally re-run the sample at our expense. Although we get very few requests for this, we believe the cost and inconvenience involved are far outweighed by the client's appreciation and loyalty. As we said above, we are indeed a commercial enterprise. We also have complete confidence that the second analysis will support the first.
With the second analysis supporting the first the matter is almost always concluded. On that very rare occasion when the client still insists the analysis is incorrect, as a GMP facility we institute FRACAS, which stands for our Failure Report, Analysis and Corrective Action System. Simply stated, we review the handling and analysis of the sample and the data that was generated. It also includes a review of the operation of the instrumentation used on the sample in question as well as samples run before and after it. A final report is then issued.
Obviously, in seeking a lab's review of its work you need to exhibit good faith. There is a difference between thinking an analysis is incorrect and not being pleased with the results of an analysis. If you have confidence in your lab (exhibited by sending it your samples) you must be ready to accept the reality supported by credible data.
This question highlights an important question you should ask when selecting an analytical lab or reviewing one you are using. You should find out to what extent the lab will support you should its analysis raise unexpected issues. It is best to know where you stand before you encounter a serious issue.
Q. I generally buy glucosamine HCL, which I know has a slightly acidic taste. I recently received glucosamine sulfate 2KCl and the salty taste was overpowering. Can you explain this?
A. Glucosamine is a natural compound consisting of a sugar (that's the "glucos") and an amine (ergo "glucosamine"). It is found in the body and in foods such as meat, fish and poultry. Through a very complex mechanism in the body glucosamine is converted into glycosaminoglycans that form large aggregating polymers, which then form the matrix in cartilage. It is no wonder then why glucosamine is looked to as a treatment for arthritis, among other ills.
It has been said that in order for the body to absorb glucosamine it must be co-ingested with a salt, and this salt improves glucosamine's stability, so salt forms are found in the trade. Usually glucosamine is ionically bonded with sulfuric acid (glucosamine sulfate salt) or hydrochloric acid (glucosamine HCl). To take it one step further, in our industry if some salt is good, more salt must be better, so you can find one of these glucosamine forms mixed (and not chemically bonded) with more salt, usually sodium salt (NaCl) or potassium salt (2KCl). You got the extra salt version (glucosamine sulfate (salt) 2KCl (more salt), which is why your product tastes so salty.
This question once again highlights the great care that must be taken in specifying and accepting raw materials. Salt is cheaper than glucosamine, so it is easy to see why a supplier may prefer to give you a 2KCl or NaCl mixture. As in all industries, being an informed consumer is a must.
Robert S. Green is the president of Integrated Biomolecule Corporation/IBC Labs, a biotechnology company that conducts nutritional supplement ingredient and finished product testing and provides research, development, production and technical marketing services. He can be reached at 520-219-2900; Fax: 520-219-6090; E-mail: firstname.lastname@example.org; Website: www.integratedbiomolecule.com.
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|Title Annotation:||QUALITY FOCUS|
|Date:||Jan 1, 2005|
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