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Testing for the presence of residual solvents in Active Pharmaceutical Ingredients (APIs) is critical for patient safety and commonly follows United States Pharmacopeia (USP) Method <467> guidelines, or more broadly, International Council for Harmonization (ICH) Guideline Q3C(R6). The gas chromatography (GC) runtime suggested by USP Method 467 ...
The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.
Egg lecithin is usually extracted chemically using ethanol, acetone, petroleum ether but not benzene or hexane due to restrictions on residual solvents by the pharmaceutical regulations. [2] It is an emulsifier, especially for parenteral use since it does not need to be metabolized.
Solvent Density (g cm-3) Boiling point (°C) K b (°C⋅kg/mol) Freezing point (°C) K f (°C⋅kg/mol) Data source; Aniline: 184.3 3.69 –5.96 –5.87 K b & K f [1 ...
Diisopropyl ether is a secondary ether that is used as a solvent. It is a colorless liquid that is slightly soluble in water, but miscible with organic solvents. It is used as an extractant and an oxygenate gasoline additive. It is obtained industrially as a byproduct in the production of isopropanol by hydration of propylene. [3]
In terms of niche applications, 1,2-dichlorobenzene is a versatile, high-boiling solvent. It is a preferred solvent for dissolving and working with fullerenes . It is an insecticide for termites and locust borers, historically used by the United States Forest Service to combat widespread bark beetle outbreaks.
Hexamethyldisiloxane can be produced by the addition of trimethylsilyl chloride to purified water: . 2 Me 3 SiCl + H 2 O → 2 HCl + O[Si(CH 3) 3] 2. It also results from the hydrolysis of silyl ethers and other silyl-protected functional groups.
A mobile phase in reversed-phase chromatograpy consists of mixtures of water or aqueous buffers, to which organic solvents are added, to elute analytes from a reversed-phase column in a selective manner. [7] [27] The added organic solvents must be miscible with water, and the two most common organic solvents used are acetonitrile and methanol.
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