ICH-Q7 GMP Manufactured Product
SODIUM DECANOATE
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.
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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|---|---|---|---|
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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
General Product Description:
- The manufacturing of Sodium Decanoate NDEC-3320 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment.
- Sodium Decanoate is a White to off-white powder
- Molecular Formula: C10H19NaO2
- Molecular Weight: 194.25 g/mol.
- CAS Number: 1002-62-6
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Sodium Decanoate NDEC-3320 manufactured at BioSpectra and its raw materials are not derived from nor come in contact with animal parts, products and/or byproducts.
- Sodium Decanoate manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Decanoate at BioSpectra are not subject to genetic modification.
- Synonyms: Sodium Caprate, Decanoic acid Sodium salt, Capric acid Sodium salt
GMP Compliance:
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.
Retest Date:
The recommended retest period for Sodium Decanoate is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and Store between 2°C and 8°C. Store in a clean and dry area. Store in the original container.
Package Sizes:
1 kg bottle, 5 kg, 10 kg and 25 Kg pails
Bulk GMP Fine Chemicals exclusively manufactured in North America
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.