6 replies to this topic

[matthewcc]

Hello all,

 

We have a product in R&D (research & development) that we have in our accelerated stability chamber (higher temperature and humidity than ambient) and at the last time point, six months, we found that the sample has many thick strand-like pieces in it. The 4-month sample was not like this.  We pulled another 6 month sample.  It too had the particles.   This is very unusual and not typical.  This is not like the normal debris on the bottle dropper.  Under the microscope, it looks blobby and plant-like (like something that would be from a plant) like fatty or greasy, but it does not look like bacteria or fungus. 

 

The formulation includes herbal extracts of Echinacea and goldenseal as well as citric acid, glycerin, and some essential oil. What do you think the pieces in the samples could be? 

 

We are regulated in the United States under 21 CFR Part 111 and 117 and we have SQF and NSF GMP certifications for manufacturing dietary supplements. 

 

Thank you,

Matthew

[GMO]

Difficult to know without knowing the product but could it be something as simple as poorly emulsified oils?  

[Tony-C]

Difficult to know without knowing the product but could it be something as simple as poorly emulsified oils?  

 

I agree GMO it sounds like it, Echinacea a possible source.

 

A photo may be useful Matthew, is this product just blended or is it homogenised?

 

Kind regards,

 

Tony

[matthewcc]

I tried to upload a couple of files. Please see if you can see those. The photos kind of look like they have plant mucilage, although I don't think that is possible since the product has gone through distillation.

 

This is a blended product.

 

I agree GMO it sounds like it, Echinacea a possible source.

 

A photo may be useful Matthew, is this product just blended or is it homogenised?

 

Kind regards,

 

Tony

 

Attached Files

•  t5 ech gold orange glyc_1_bak.jpg   91.3KB   0 downloads
•  t5 ech gold orange glyc_bak.jpg   74.41KB   0 downloads

[GMO]

Is this for a food application?  Looks like micelles or droplets of oil to me, especially the second photo. 

 

Do you have anything in there which could act as an emulsifier?  I'm guessing you have something watery in there to dissolve the citric acid and glycerol.  Could you include something amphiphilic?  Like a fatty acid perhaps if you're aiming for something natural or if you make the salt of it that's basically the same as a soap?  (You'd have to check on suitability for consumption or skin use depending on what you're making.) 

 

What that will do is help make smaller droplets into micelles which mix more thoroughly and form an emulsion. You'll never get your oils and water completely mixing but it will look like they do.  I bit like how detergents work to get fatty residues cleaned off into water or like the egg works as an emulsifier in mayonnaise to suspend the water in the oil.

[matthewcc]

It's a certified organic dietary supplement. I am not aware of any emulsifier in the product. Theoretically, it could include something amphiphilic; however, we are limited on what we can use in a certified organic dietary supplement, so that would be a challenge. I agree with what you are saying and will suggest it to the group; we are really picky about what we add to our products.

 

Is this for a food application?  Looks like micelles or droplets of oil to me, especially the second photo. 

 

Do you have anything in there which could act as an emulsifier?  I'm guessing you have something watery in there to dissolve the citric acid and glycerol.  Could you include something amphiphilic?  Like a fatty acid perhaps if you're aiming for something natural or if you make the salt of it that's basically the same as a soap?  (You'd have to check on suitability for consumption or skin use depending on what you're making.) 

 

What that will do is help make smaller droplets into micelles which mix more thoroughly and form an emulsion. You'll never get your oils and water completely mixing but it will look like they do.  I bit like how detergents work to get fatty residues cleaned off into water or like the egg works as an emulsifier in mayonnaise to suspend the water in the oil.

[GMO]

It's a certified organic dietary supplement. I am not aware of any emulsifier in the product. Theoretically, it could include something amphiphilic; however, we are limited on what we can use in a certified organic dietary supplement, so that would be a challenge. I agree with what you are saying and will suggest it to the group; we are really picky about what we add to our products.

 

Understood but if you have oily ingredients and watery ingredients they will eventually split.  There are natural emulsifiers.