USP MINERAL OIL FACTS!
https://renkertoil.com/the-critical-role-of-usp-grade-mineral-oil-in-medical-product-stability/
About USP-Grade Mineral Oil
Mineral oil, often called white oil, comes in many purities. Only one meets the strict limits set by the U.S. Pharmacopeia (USP). To earn the USP label, each batch must:
Demonstrate purity with no aromatics as measured by sensitive UV absorption.
Contain no cancer-linked polycyclic aromatic hydrocarbons (PAHs).
Hit narrow ranges for viscosity, color, and odor.
Come from facilities working under current Good Manufacturing Practices (cGMP).
In short, USP-grade mineral oil is tested, traced, and trusted—a clear step above tech-grade or cosmetic-grade oils. This standard earns a place for these oils in the National Formulary (NF).
“The USP-NF has for 185 years provided public standards for medicines. These standards provide information on the quality, strength, and purity of the ingredient or product and ensure consistency in the medicines taken by the public. USP feels strongly that the success of any drug importation program implemented in the United States must recognize the critical role of public standards and require adherence to the official US compendia – the USP-NF. Adherence to the public standards in the USP-NF can achieve, via testing to the standards of a monograph and with the use of USP Reference Standards, the assurance that medicines meet the quality expected by patients and practitioners.” – Dr. Todd Cecil, Vice President, USP (testimony before the U.S. Senate)
How USP-Grade Mineral Oil Protects Drug Stability
Moisture barrier – An inert compound, USP-grade mineral oil creates a thin film on tablets or powders, blocking water vapor that can trigger early breakdown and also functions as dust control.
Oxygen shield – Its low reactivity keeps air away from sensitive actives.
Plasticizer in soft-gel shells – Small amounts act as an excipient (inert substance) that keeps gelatin flexible, cutting the risk of cracks during storage; USP excipients are certified with annual independent audits to ensure safety.
Texture control in creams and ointments – Consistent quality simplifies durable emulsification so the dose spreads evenly every time.
Because the oil itself does not change in normal heat, light, or humidity, it acts like a built-in insurance policy for the formulator.
Real-World Uses of USP-Grade Mineral Oil
These are just a few examples of mineral oil applications in pharmaceuticals and food supplements, for which the highest level of purity is critical.
Eye Ointments — Smooth, Sterile Protection
Pharmacy‐shelf eye lubricants use a USP-grade mineral oil blend to keep the base silky and germ-free. The oil forms a gentle moisture barrier, so delicate eye tissue stays calm instead of drying out.
Soft-Gel Vitamins — Flexible Shells That Don’t Crack
A few drops of mineral oil act as a plasticizer inside gelatin shells, letting them bend without breaking during filling, shipping, and months on a store rack. Softer shells also keep capsules from sticking together in the bottle.
Nasal Sprays — Long-Lasting Moisture Relief
In saline and medicated sprays, USP-grade mineral oil coats nasal passages and slows water loss—as shown in ethical testing on rabbits. That gentle film eases dryness and protects sensitive membranes—especially in arid or cold climates.
Topical Creams & Salves — Even Texture, Every Dose
Many prescription and over-the-counter creams list mineral oil as an inactive ingredient. It keeps the formula smooth so the active drug spreads evenly and delivers the right dose with each squeeze.
