What is “Ferric oxide red USP NF”?
Ferric oxide red USP NF is a red iron oxide pigment made from iron(III) compounds. In pharmaceutical and manufacturing contexts, “USP NF” means it is produced and tested to meet the standards in the United States Pharmacopeia (USP) and the National Formulary (NF) for identity, purity, and other quality requirements. It’s commonly used as a colorant in tablets, capsules, coatings, and other finished dosage forms.
What does USP/NF imply for quality and use?
When a material is labeled “USP NF,” it signals that regulatory-facing quality criteria are defined and that the supplier’s product is intended to comply with those compendial standards (for example, limits on impurities and tests supporting consistent identity and composition). This matters for drug manufacturers because colorants can contribute impurities if not controlled tightly.
What is it used for in pharmaceuticals?
Ferric oxide red USP NF is mainly used as a coloring agent for dosage forms. Because it’s an inorganic pigment, it’s typically selected for color stability and because it can be incorporated into solid oral dosage technologies at appropriate levels defined by formulation practice and regulatory guidance for excipients.
Is it the same as “iron oxide red” used outside pharma?
Yes in a broad sense, because ferric oxide red is the chemical identity. But “USP NF” is the key difference: non-compendial grades may not meet the same specifications or documentation that drug manufacturers request for finished pharmaceutical products. That distinction often affects which grade is acceptable for drug product formulation and filings.
Where can I verify the exact USP/NF monograph details?
The specific USP/NF requirements (such as identity tests and impurity limits) depend on the exact compendial monograph used for ferric oxide red. If you share the exact label text from the product you have (including whether it says “Ferric Oxide Red” vs “Ferric Oxide Red, USP/NF,” and any additional designations), I can help you narrow down what to look for in the USP/NF material.
Do you mean a drug, a supplement, or an excipient listing?
Ferric oxide red USP NF is typically an excipient/colorant, not an active ingredient. If you’re trying to find it in a drug product label, tell me the product name (or paste the ingredient section), and I can help interpret what it means in that context.
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