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Excipient

ICH-Q7 GMP Manufactured Product

SODIUM DECANOATE

GMP, Excipient Grade

Minimum Order Quantity: If Stock-5kg / No Stock-30kg Lead Time: If Stock, 1-month/ No Stock, 3-months
COAs Spec Sheet

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Product Code: NDEC-3201
Intended For Use As An Excipient

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

ANALYSIS

SPECIFICATIONS

Appearance  
White to off-white powder
Assay (Dried basis)  
95.0% – 105.0%
Elemental Impurities Complies with USP <232>
Identification (IR)  
Matches the reference
Impurities (GC)

Single Impurities

Sodium Octanoate (Octanoate Acid)

Sodium Nonanoate (Nonanoic Acid)

Total Impurities

≤ 1.0%

Report

Report

≤ 3.0%

Iron  

Report

Loss on Drying  

5.0% max.

pH(10%)  
9.0-11.0
Residual Solvent (GC) Ethanol
≤ 5000 ppm
Sodium Quantification  
Report
Solubility in Water  
Passes Test
Water (KF)  
≤ 5.0%

 

Printable Version

General Product Description:

  • The manufacturing of Sodium Decanoate NDEC-3201 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-3201 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-3201 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.