ÍøÆØÃÅ

Pharmaceutical compounding with pharma ethanol is the result of many decisions such as deciding to choose USP-grade ethanol over other solvents such as propylene glycol USP or diethylene glycol monoethyl ether NF. We make no specific recommendations regarding your formulation and suggest referring to a reputable formula database such as PCCA to determine the ideal solvent. But if your compounded formulation includes ethanol, there are key factors to understand before buying USP ethanol online.

Pharma Ethanol Uses

Pharma ethanol has many uses in compounding pharmacies: solvent, antimicrobial preservative (at concentrations of 10% or greater), stock solution, topical vehicle, penetration enhancer, and disinfectant. When used in topical preparations, ethanol also has penetration enhancement properties.

Ethanol is suitable for human consumption, where isopropyl or denatured alcohol are not. So for oral compounded preparations, USP ethanol is the only option. Pharma ethanol contains no denaturant additives such as ethyl acetate, kerosene, or isopropyl alcohol making the solvent 100% pure or GRAS (Generally Regarded As Safe).

Different Grades of Ethanol

Ethanol is manufactured for many applications under these production standards:

• United States Pharmacopoeia (USP) ‒ referred to as USP or pharma grade ethanol manufactured using USP (and similarly European, British and Japanese Pharmacopoeias) standards that guide with strict production, storage, inspection, and packaging procedures. Suitable for consumption so that it can be used in medications and perfumes.
• Food Chemical Codex (FCC) ‒ referred to as food grade ethanol that is tested for toxicity to be suitable for human consumption, thus free from heavy metals such as mercury or trace elements such as arsenic, cadmium, or lead so that it may be used to make beverages, sanitisers and food preservative, often for baked goods.
• American Chemical Society (ACS) ‒ referred to as ACS Grade, the highest purity chemical grade for laboratory and analytical research

The 3 grades above are the most common for use in pharmaceutical facilities, but when purchasing ethanol for a pharmaceutical lab, many terms may be encountered. These help buyers make informed decisions about purity as well as the tailoring of a product to a specific application or procedure. In addition to the standards that, when referenced in product descriptions, give you information about appropriate applications, other terms are also used:

• Analytical Grade ‒ High-purity reagents suited for analytical procedures.
• Bacteriological Grade ‒ Reagents for most molecular biology and cell culture applications.
• Electrophoresis Grade ‒ For use in electrophoresis applications
• Histology Grade ‒ Produced for use in histology and immunohistochemistry applications.
• HPLC Grade ‒ High-quality tailored for use in HPLC applications.
• Lab Grade ‒ High-quality ethanol with the potential to contain undefined impurities best suited for educational or demonstration purposes.
• Medical Grade ‒ Reagents rigorously tested and screened for trace pathogens.
• Molecular Biology Grade ‒ Tested for impurities such as enzymatic activity, DNases, RNases, proteases, and nucleic acid contaminants.
• NF Grade ‒ Complies with National Formulary specifications. Note that USP now encompasses NF and you may see USPNF designated on products.
• Reagent Grade High-quality materials that typically meet the same standards as ACS, so the term may be used interchangeably with ACS grade.
• Pharmaceutical Grade ‒ a “catch-all” grade that indicates production under a national pharmacopoeia (USP, BP, JP, EP)
• Technical Grade ‒ Chemicals of good quality, suitable for industrial or demonstrative purposes.
• Tissue Culture Grade ‒ High-purity products, suitable for use in tissue culture applications.
• Ultra Pure ‒ Purity level exceeding USP monographs where impurities must be very low stated in parts per trillion or parts per billion.

It is no wonder that purchasing pure ethanol for USP pharmaceutical, nutraceutical, botanical, research and development, and other industrial use can be daunting. But for any material to be used as a component of a patient-consumed (includes topical and inhaled) product, look for USP, pharma and ultra-pure grades.

Cleanroom Connection can help your facility select the proper pharmaceutical ethanol for your products and processes. The most frequently purchased ethanol products for pharma compounding are Decon Labs:

• 140 proof ethanol (70% ethyl alcohol)
• 190 proof ethanol (95% ethyl alcohol)
• 200 proof anhydrous ethanol (100% ethyl alcohol)