Biotin - The Good, Bad and Indifferent - How To Tell.

There are good and bad forms of Biotin. To qualify as pharmaceutical grade, pure Biotin must be greater than 97.5% pure. There are also a lot of other measures it must conform to.


Biotin

A useful comment at this point is how to identify a good form of Biotin you buy in either a concentrated, powered form or what grade of Biotin has been used in capsule or pill production.

In brief, to qualify as Pharmaceutical Grade, the pure Biotin must conform the following measures. It must be :

            Greater than 97.5% pure,
            Have a specific rotation of between +89 and +93 degrees,
            Have not more than 2% impurities

There are a lot of other measures that it must conform to, to be considered fit for human consumption. For our purpose, when selecting a biotin these are the most important.

What I call the Ultra High Grade of biotin that we use in most of our products is specifically manufactured at the top of the acceptable range that is considered acceptable for a Pharmaceutical Biotin. What I call a standard Pharmaceutical grade is one that has been manufactured to fit anywhere in the acceptable range.

A biotin manufactured to have purity greater than 97.5% is far cheaper to make than a biotin that is made to be greater than 99% pure. I hope for obvious reasons.

Always ask for a Certificate of Analysis (CoA) from the manufacture of the Biotin. It is also useful to see a retest certificate that on-sellers/repackages sometimes have done. CoA’s are pretty standard and should include an Impurities field. This is usually measured in an identifier like "NMT 2%" Meaning Not More Than 2%. Here's a typical Certificate of Analysis (CoA).  This tells you that it is 99.44% pure. There are two main standards that are used to govern the quality of chemicals manufactured for human consumption, USP and FCC.  The specification for a Pharmaceutical (Pharma) grade under the current USP standard is 97.5-102% pure and FCC is 97.5-100.5%. As you can see FCC has a tighter specification than USP. Here we will only discuss USP standards unless otherwise stated.  Manufacturing costs increase exponentially the closer the manufacturer gets to 100% pure.  However, CoA's do not tell you everything you need to know about the Biotin you are buying.

Biotin is a chemical compound with the formula C10H16N2O3S. The compound is known as an isomer, as it can exist in different forms with the same chemical makeup.  There are different types of isomers, structural and positional to name a couple but I won't go into this detail here. Biotin can take the form of eight different isomers which have the same chemical makeup, but with different geometry at three of the Carbon atoms at the centre of the molecule. An easy way it was explained to me was like having a left and right hand versions. Both are identical, just mirror images of each other. But with Biotin there are 8 of them. Some of these occur naturally and some don't. Each of the naturally occurring isomers have different levels of biological availability to different organisms. As far as I can tell, the term D-Biotin is used rather generically to describe all the naturally occurring forms which can have from zero to around 50% biologically activity. A more accurate designation given to a more biologically active form appears to be one identified as d-(+)-biotin. That is d not D, there is a difference I found out recently, d has the same meaning as + and refers to a positive spin on reflected polarised light, whereas D refers to the geometry of a molecule (left hand/ right hand).

Biotin Manufacturing: Biotin is manufactured using several different methods. Some are purely chemical in nature others are a combination of natural (using biological organisms to create the biotin) and chemical and mechanical methods to extract and purify the biotin. By controlling things like moisture, pressure, heat, light, and other radiation sources etcetera during the manufacturing processes, concentration of the different isomers in the finished product can be influenced. The tighter the manufacturing is controlled, the more consistent the finished product will be. Generally a manufacturer will test multiple samples to confirm purity etc. and their testing gives a much more accurate result than a one off test that an on-seller might get done. So always ask to see the manufacturers CoA as a one off retest certificate is inaccurate and only good to indicate that the manufacturers goods are what they say they are.

How to gauge biological availability? Scientists have worked out that if you expose a Right handed or a Left handed isomer to polarised light, it will reflect the light in either a positive (d, +) or negative (l,-) direction (Clockwise or Anticlockwise). With biotin, they have determined that the isomers that reflect polarised light in a positive (clockwise) direction coincide to those with higher growth rates in certain organisms. Hence, they are said to be biologically active forms of biotin. Which are most biologically active for humans? I don’t think we really know as I have not been ably to locate any papers that investigate this, but the specification used to designate a pure biotin as a Pharmaceutical Grade of biotin defines a specific rotation of between +89 to +93 degrees.

Now I make a concerted effort to ensure the type that is used in our formulations is always greater than 99% pure and has a specific rotation greater than 92 degrees whenever possible. The biotin we uses for most of our high biotin products is right at to top end of the specification used to define Pharma grade biotin, both in terms of purity and specific rotation. I have found that some suppliers are not able to tell what version of Biotin they supply is. Or even that that they are aware there is a difference. Only that the biotin they use is Pharmaceutical Grade. The only product at this stage that we do not use an Ultra High Pharmaceutical Grade of biotin is our MS-High Biotin. For this product we use a Standard Pharmaceutical grade of biotin, which is significantly cheaper as the manufacturer does not have to have such tight manufacturing controls in place.

So, in brief, the Biotin we use for most high Biotin products is what we refer to as an Ultra-High Pharma Grade and is manufactured to always be at the top end of the USP specification. There is another little secret that renders our Ultra Grade biotin easier for the intestine to absorb at such high concentrations but I am not quite ready to share that yet.

The Biotin we use for our cheaper high biotin product, MS-High Biotin, is a Standard Pharmaceutical Grade and can be anywhere in the USP specification.

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