Product Category

Excipient

ICH-Q7 GMP Manufactured Product

SODIUM DECANOATE
GMP Excipient Grade

Product Code: NDEC-3220 | Previously: ND3220

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.

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance  
White to off-white Powder
Assay (Dried basis)  
97.0% – 103.0%
Identification (IR)  
Passes Test
Loss on Drying (LOD)  

3.0% max.

pH (10%)  

9.0 – 11.0

Single Impurities (GC)  
<1.0%
Sodium  
Passes Test
Solubility in Water  
Passes Test
Water (KF)  
1.5% – 3.0%
Printable Version
List of C of As files
NDEC-0124-00012_NDEC-3220.pdf
NDEC-0124-00011_NDEC-3220.pdf
NDEC-0124-00008_NDEC-3220.pdf
NDEC-0124-00010_NDEC-3220.pdf
NDEC-0124-00009_NDEC-3220.pdf
NDEC-0124-00007_NDEC-3220.pdf
NDEC-0124-00006_NDEC-3220.pdf
NDEC-0124-00005_NDEC-3220.pdf
NDEC-0124-00004_NDEC-3220.pdf
NDEC-0124-00003_NDEC-3220.pdf
NDEC-0124-00002_NDEC-3220.pdf
NDEC-0124-00001_NDEC-3220.pdf
NDEC-0123-00006_NDEC-3220.pdf
NDEC-0123-00005_NDEC-3220.pdf
NDEC-0123-00003_NDEC-3220-92.pdf
NDEC-0123-00003_NDEC-3220.pdf
NDEC-0123-00001_NDEC-3220.pdf
NDEC-0122-00014_NDEC-3220.pdf
NDEC-0122-00013_NDEC-3220.pdf
NDEC-0122-00012_NDEC-3220.pdf
NDEC-0122-00011_NDEC-3220.pdf
NDEC-0122-00009_NDEC-3220.pdf
NDEC-0122-00008_NDEC-3220.pdf
NDEC-0122-00006_NDEC-3220.pdf
NDEC-0122-00005_NDEC-3220.pdf
NDEC-0122-00003_NDEC-3220.pdf
NDEC-0122-00004_NDEC-3220.pdf
NDEC-0121-0022_NDEC-3220.pdf
NDEC-0121-00017_NDEC-3220.pdf
NDEC-0121-00015_NDEC-3220.pdf
NDEC-0121-00014_NDEC-3220.pdf
NDEC-0121-00008_NDEC-3220.pdf
ND3220-012-1220_NDEC-3220.pdf
NDEC-0122-00002_NDEC-3220.pdf
NDEC-0122-00001_NDEC-3220.pdf
NDEC-0121-00024_NDEC-3220.pdf
NDEC-0121-00023_NDEC-3220.pdf
NDEC-0121-00022_NDEC-3220.pdf
NDEC-0121-00021_NDEC-3220.pdf
NDEC-0121-00020_NDEC-3220.pdf
NDEC-0121-00016_NDEC-3220.pdf
ND3220-014-0121.pdf
ND3220-001-1018 K003 (2).pdf
ND3220-003-1018 K003 (2).pdf
ND3220-002-1018 G500 (2).pdf
ND3220-003-1018 G500 (2).pdf
ND3220-013-1220.pdf
ND3220-011-1120.pdf
ND3220-010-0820.pdf
ND3220-009-0820.pdf
ND3220-004-1218 G500.pdf
ND3220-005-1218 K003.pdf
ND3220-005-1218 G500.pdf
ND3220-004-1218 K003.pdf
ND3220-004-1218 G025.pdf
ND3220-007-0219.pdf
ND3220-006-0119.pdf
ND3220-004-1218.pdf
ND3220-003-1018.pdf
ND3220-002-1018.pdf
ND3220-001-1018.pdf

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General Product Description:

  • The manufacturing of Sodium Decanoate NDEC-3220 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-3220 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-3220 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

Additional Packaging Information

https://www.biospectra.us/technical/packaging