Sodium Decanoate, or sodium caprate, is the sodium salt of caproic acid, a 10-carbon saturated fatty acid. It has amphiphilic character and can form micelles and liquid crystalline phases in aqueous solution. Sodium decanoate’s properties may help elucidate the transport of biologically active molecules and as a final component of a finished drug product, it may serve to enhance the bioavailability of the API. BioSpectra’s Bio Excipient Grade of Sodium Decanoate is supported by a Type IV drug master file submitted with the FDA.
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BIOSPECTRA
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SODIUM DECANOATE
Pharmazeutische Inhaltsstoffe
TROMETHAMINE (TRIS BASE) USP, EP, JP, LBLE, GMP EXCIPIENT GRADE TRIS-3255
Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.
Pharmazeutische Inhaltsstoffe
DEXTRAN SULFATE 8000 NA, LBLE, GMP GRADE DXSE-4250
Dextran Sulfate 8000 Na is a polyanionic derivative of dextran, produced by the esterification of the glucose polymer (glucan polysaccharide) with chlorosulphonic acid. Dextran fractions are characterized by their average MW and MW distribution with predominantly 1-6 glycosidic bones and 5% or less of 1-3 branching. Each base dextran polymer has characteristics unique to the specific strain of bacteria from which is was derived. In addition to variables in molecular weight and branching, the level of sulfonation adds to the unique character and performance of the finished product in terms of its intended end use. Dextran Sulfate 8000 Na, 8000 MW is used in the solubilization and purification process of protein molecules intended for use in a final drug product. Dextran is neutral in pH and soluble in water. It is easily filtered and biodegradable.
Pharmazeutische Inhaltsstoffe
GUANIDINE HCL, NF GRADE, GMP EXCIPIENT GRADE GHCL-3220
Guanidine Hydrochloride Buffer is a strong protein denaturant that functions as a chaotropic agent. As a denaturant, it acts to unfold proteins and turn them into their original polypeptide chains. As a chaotropic agent, it breaks down the structure of proteins. Guanidine Hydrochloride Buffer is commonly used in the purification of RNA by dissociating the RNA into its nucleic acids and protein forms. At higher concentrations, Guanidine Hydrochloride Buffer decreases enzyme activity. It is also used to increase the solubility of hydrophobic molecules.
Pharmazeutische Inhaltsstoffe
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