USP Grade (United States Pharmacopeia) chemicals

What the grade means

USP grade material complies with its monograph in the United States Pharmacopeia and National Formulary, published by the United States Pharmacopeial Convention. Drug substance monographs sit in the USP and most excipient monographs in the NF, which is why excipients are often labelled NF. The FDA enforces compendial standards, and the text is updated through regular official publications.

What a monograph controls

• Definition and assay limits.
• Identification, often using USP Reference Standards.
• Organic impurities, residual solvents to General Chapter 467 and elemental impurities to Chapters 232 and 233.
• Specific tests such as water, residue on ignition or pH, plus packaging and storage.

Sodium bicarbonate USP, for example, requires 99.0 to 100.5 percent assay on the dried basis and loss on drying of 0.25 percent at most.

When to choose it

Choose USP or NF grade for products sold in the United States and for buyers whose regulators reference USP-NF.

Documentation

Each lot ships with a COA citing the official USP-NF text and a GHS SDS. Many items are listed in APIs.