Grade Confusion

[Cool_Breeze]

I’m trying to sort what is the better approach for me in procuring base mixing materials for ecigarette eliquids. Of course ECF has provided useful information. Below is some of what I have come across and is excerpted. Further down are some conclusions, speculations and questions. Some material other than what is copied below may be involved in the questions.

SmokeyJoe- 12-02-2009, 04:09 PM


1. What is the USP?

The USP stands for United States Pharmacopeia. The USP is the official pharmaceutical compendium in the United States. It includes chemical descriptions, identifying tests, and purity tests, primarily for active ingredients. All materials listed in the USP are considered drugs by law and subject to all the U.S. Food & Drug administration requirements pertainingto drugs.

USP grade is pharmaceutical grade (the same grade a drug company orpharmacist manufacturing or compounding a formulation for human use would berequired to utilize) is the only grade that has any FDA regulation and oversight associated with it’s manufacture, labeling and marketing.

When you buy USP grade you are assured of 3 things:

1. The product was made tothe exact specifications listed in it’s USP monograph
2. The manufacturer is FDAregistered and licensed and the product HAS been approved (including thelabeling/marketing material) by the FDA as meeting USP specifications.
3. The product was made in aFDA certified facility using cGMP (current good manufacturing practices) whichare stringent to ensure lot to lot consistency.

rolygate - 03-11-2012, 12:52 PM

Only the pharma grade of these materials (PG, VG/AG, PEG) should be used for inhalation, in theory, since all other grades contain contaminants to an increasing degree (the difference between the grades is the percentage of contaminants).
These carriers are made in four grades:

1. • Pharmaceutical Grade - for human consumption including by inhalation
   • Food Grade - for human consumption by ingestion but not inhalation
   • Agricultural (Farm) Grade - for use in connection with animals
   • Industrial Grade - for use in machinery, manufacturing and similar purposes

All of these grades except Pharma Grade contain contaminants, in increasing amounts as the grade quality reduces. This is the difference inthe grades.

DO NOT buy FARM GRADE OR INDUSTRIAL GRADE MATERIALS FOR INHALATION - THEY ARECONTAMINATED.
It is possible that a USP product can be either pharma grade or food grade.The USP designation only refers to a general production regime and does notcover the percentage of contaminants. The USP designation only refers to ageneral production regime and does not cover the percentage of contaminants. So a USP product might be considered safe for inhalation; or it might, on test, prove inadvisable to inhale. The only product that is guaranteed to be suitablefor inhalation is a product that is (a) designated by the manufacturer as Pharmaceutical Grade, and that (b) also has a provable license for inclusion ina specific inhalable medicine. Needless to say this is virtually impossible tolocate for the individual buyer. A vendor would be able to buy e.g. Dow Optim glycerine in quantity, for mixing down (or its PG equivalent), and be assured thematerial is suitable. This however doesn't take into account the nicotine basecarrier PGor glycerine.


· Itseems that USP can apply to both Food Grade and Pharmaceutical Grade. Is this correct?
· Then is it correct that USP cannot be applied to Industrial Grade and Agricultural Grade?
· Agallon of Propylene Glycol purchased from an agricultural supplier AND labeledUSP is at least Food Grade – Correct or Incorrect?
· Food Grade products ‘could’ be of the same contents as Pharmaceutical Grade, but would not be labeled so as per the rebottling process it may have gone through. – Correct or Incorrect?
· Should USP actually be referred to in terms of ‘grade?’
· From the above quoted material one might conclude that Pharmaceutical, Food, Agriculture and Industrial are grades within USP. Would that be an errant conclusion? If not, what/who determines the 4 grades?
· What is the proper light in which to view USP relative to the Grades offered?

 

[Hoosier]

Yeah, this is a source of much confusion.

Primarily USP is a purity standard known as Pharma. (It also covers other things, but let's stick with the purity.)
Food grade is primarily a purity standard and is suppose to be fine for human consumption. (It also covers a few other things, but we are sticking with the one thing.)
Agricultural grade is also a purity standard and is suppose to be fine for consumption by animals that are consumed by humans. (It is really close to food grade)
Industrial is to not have contaminates that could damage machinery, but isn't much of a purity standard and doesn't have to be safe for any living thing to consume.

You can use USP for any of the other 3. You could use Food grade for Agricultural or Industrial, but not Pharma. You could use Agricultural for Industrial, but not food or Pharma. Industrial grade cannot be used for anything but.

So you could have a USP labeled product that is also labeled Food, Farm, and Industrial, or a Food grade that is also labeled for Farm and industry, or Farm labeled product also labeled for industrial use.

Now, USP purity is a standard so to be able to use the USP on the label requires the product meet that standard at a minimum. A Certified USP label means the product was tested by the USP labs themselves and is usually only done for research or testing usage. If you buy a USP labeled bottle and unseal it, it is no longer USP unless it was opening in a certified environment, even if the container is immediately resealed.

Who determines?
USP for USP
FDA for Food
USDA for Farm
The manufacturer assumes liability for industrial.

 

[r77r7r]

Subscribed and bumped.

 

[JUDGMENT AFFIRMED]

What good questions Cool Breeze.
It took me some time to get over the "for animal use only" thing, but I got Hoosiers piont and it seems to be true.
The marketing and grading "clouds" the picture.
Go to Dow's website and you will see that their PG [ the DOW Puraguard ] is marketed for the Pharmaceutical industry, the food processing industry and the animal feed industry. And if you click the PDF's under each, its the same PG, with 99.8% or greater purity.

 

[Ilovenips]

Thought this would clarify but now more confused. I am trying to find a legit, reputable online ejuice vendor that sells 100 percent vg that is pharmaceutical USP grade. I am finding sites I go on... always say food grade USP.... Please help me.

 

[Hoosier]

USP is also known as "Pharma" grade.

Because it qualifies for "Pharma" it is also allowed to be sold for Food Grade use, Agricultural Grade use, and even Industrial Grade use.

So you are seeing USP, aka: Pharam, being sold for food also. There is only one specification above USP and it is usually sold in very small quantities and is very expensive for calibration purposes.

Think of it this way...
95.5% purity to be Great
94% purity to be Good
92% purity to be Okay
80% purity to be So-So

If I had Great, I could use it for Good, Okay, and So-So uses.
If I had Good, I could use it for Okay and So-So uses.
If I had Okay, I could use it for So-So uses.

Now assume that Great=USP, Good=Food, Okay=Ag, and So-So=Industrial. Or if it is pure enough to be USP, that does not make it too pure for all other uses, so it is acceptable to have the label also say Food Grade, Agricultural Grade, and even Industrial Grade. It is still USP (Pharma)...