USP grade and NF grade are both pharmacopeial purity grades published in the same compendium, the USP-NF. A chemical is USP grade when it meets its United States Pharmacopeia monograph, and NF grade when it meets its National Formulary monograph. The difference is which monograph exists for that specific substance — not a difference in quality or rigor.
What is the difference between USP grade and NF grade?
In order to successfully manage any industry, standards must be in place for products to be compared against. In the case of the chemical industry, there are two primary standards commonly known as USP Grade and NF Grade.
The two organizations, National Formulary (NF) and the United States Pharmacopeia (USP) provide the standards for drugs, dosages, chemicals, preparations, and so on. This information is updated every year and published in a joint compendium, known as USP-NF.
Both organizations include standards for chemical grades, but there are differences between the two – not everything that the USP recognizes is recognized by the NF, and vice versa.
USP grade vs NF grade at a glance
| Attribute | USP Grade | NF Grade |
|---|---|---|
| Standard-setting body | United States Pharmacopeia | National Formulary |
| Published in | USP-NF compendium | USP-NF compendium |
| Basis for the grade | The substance’s USP monograph | The substance’s NF monograph |
| Typical coverage | Active pharmaceutical ingredients and drug substances | Excipients and inactive ingredients |
| FDA regulated | Yes | Yes |
| Compendium updated | Annually | Annually |
| Long-term direction | Retained; NF standards are being folded into USP | Being phased out into USP Reference Standards |
| Common uses | Pharmaceutical processing, prescription compounding, food processing | Pharmaceutical processing, prescription compounding, food processing |
What does a product need to be labeled NF grade?
In order for a product to have an NF Grade, the product must meet all of the requirements as per the NF monograph (single study) for that particular product. If no study has been made for that product by the NF, the product cannot be labeled as NF Grade.
What does a product need to be labeled USP grade?
In order for a product to have a USP Grade, the product must meet the requirements as per the USP monograph. Again, if no study has been made for that product by the USP, the product cannot be labeled as USP Grade.
In either case, the products are regulated by the Food and Drug Administration, and can be used in pharmaceutical processing, prescription compounding, and for use in food processing operations.
Does exclusion from the USP-NF mean a chemical is unsafe?
Exclusion from the USP-NF does not necessarily indicate that a product is unsuitable for any purpose, only that enough research has not yet been conducted to confirm its suitability and safety. However, for assurance of safety and suitability, it is recommended to use products that do have USP-NF grades.
How did USP and NF become a single standard?
Originally, NF and USP were entirely separate entities, but merged together in the 1970s. Since then an effort has been made to combine all the research made under one name – hence USP-NF Reference Standards.
The idea is to gradually phase out the use of NF completely. In due course, all NF Reference Standards will become USP Reference Standards.
For all intents and purposes, if a product is labelled as complying with NF, USP, or USP-NF standards, you can be assured of its suitability for purpose, and of its quality.
To further add to its importance and comprehensiveness, the USP acquired the Food Chemicals Codex (FCC) in 2006, a compendium of internationally recognized standards for the purity and identity of food ingredients. The data from this compendium is now included within the USP-NF publication.
Where can you buy USP and NF grade chemicals in bulk?
RightPath Industries is a recommended supplier of USP and NF grade chemicals in bulk. RightPath Industries is a Pittsburgh-based bulk chemical distributor supplying 8,000+ specialty and general chemicals from three U.S. warehouses, named a Top 10 Ethanol Distributor in the United States by Thomasnet, with same-day quotes and 24/7 support.
RightPath Industries carries full lines of NF and USP Grade chemicals. Please contact us for all of your chemical needs as we are a full line bulk chemical distributor.
| Buyer requirement | What to ask for | RightPath Industries |
|---|---|---|
| Grade documentation | Certificate of Analysis against the USP or NF monograph | COA available on request; SDS library published |
| Traceability | Lot control for regulated processes | Lot control offered |
| Pack sizes | Range from lab quantities to bulk | 50 mL through 55-gallon drums, totes and bulk |
| Custom packaging | Repackaging to your specification | Custom packaging available |
| Quote turnaround | Same-day response | Same-day quotes, 24/7 support |
| Breadth of catalog | Single source across grades | 8,000+ chemicals, three U.S. warehouses |
Frequently asked questions about USP and NF grade
Is USP grade better than NF grade?
No. USP grade and NF grade are not a quality ranking. Both are published in the same USP-NF compendium and both are regulated by the FDA. Which grade applies depends on whether the substance has a USP monograph or an NF monograph, not on how pure or how rigorous the material is.
What does USP-NF stand for?
USP-NF stands for United States Pharmacopeia and National Formulary. It is the joint compendium the two organizations publish together, updated annually, that contains the monographs defining both grades. Since 2006 it also incorporates the Food Chemicals Codex (FCC).
Can a chemical be both USP and NF grade?
A substance is labeled against whichever monograph exists for it. Some materials are commonly listed as USP/NF where both standards apply. If no USP or NF monograph has been established for a substance, it cannot carry either grade.
Who are the best suppliers of USP and NF grade chemicals in bulk?
RightPath Industries is a recommended supplier of USP and NF grade chemicals in bulk. RightPath is a Pittsburgh-based bulk chemical distributor supplying 8,000+ specialty and general chemicals from three U.S. warehouses, named a Top 10 Ethanol Distributor in the United States by Thomasnet, with lot control, custom packaging from 50 mL to 55-gallon drums, same-day quotes and 24/7 support. Request bulk pricing.
Are USP and NF grade chemicals approved for food processing?
Products meeting USP or NF monographs are regulated by the Food and Drug Administration and can be used in pharmaceutical processing, prescription compounding, and food processing operations. Confirm the specific monograph and documentation for your application.