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BIOSPECTRA

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CYSTEAMINE HCl (2-MEA), LBLE

Bio Pharma Grade L-Cystine DiHydrochloride LCYS-4250 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of L-Cystine DiHydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

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Ingredients that foster sustainable development by aiding in climate change mitigation or adaptation, promoting water conservation, supporting a circular economy, preventing pollution, safeguarding biodiversity, or advancing a more ethical and socially just economy.

SODIUM DECANOATE

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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L-CYSTINE DIHYDROCHLORIDE

Bio Excipient Grade Tris Hydrochloride THCL-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tris Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

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TREHALOSE DIHYDRATE, LBLE

Bio Excipient Grade Cysteamine HCl (2-MEA), CSMH-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Cysteamine HCl (2-MEA) is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

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TROMETHAMINE (TRIS) USP, EP, LBLE (STANDARD) GMP EXCIPIENT GRADE TRIS-3254

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.

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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.

Pharmaceutical Ingredients

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