ICH-Q7 GMP Manufactured Product
Sodium Decanoate – Blend Batch, is a blend of multiple production batches to provide the end-user with a larger blended, uniform Lot size. 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.
CAS #: 1002-62-6
Formula: C10H19NaO2
Sol. In H2O (g/L): 0.1
F.W.: 194.25 g/mol.
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ANALYSIS |
SPECIFICATIONS |
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White to off-white Powder | ||
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97.0% – 103.0% | ||
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Passes Test | ||
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3.0% max. |
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9.0 – 11.0 |
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≤1.0% | ||
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Passes Test | ||
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Passes Test | ||
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1.5% – 3.0% |
Printable Version
Bio Excipient Grade Sodium Decanoate NDEC-3320 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Sodium Decanoate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Sodium Decanoate is two years from the date of manufacture.
Ship and Store between 2°C and 8°C. Store in a clean and dry area. Store in the original container.
1 kg bottle, 5 kg, 10 kg and 25 Kg pails
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.