Sodium Decanoate

Excipient

ICH Q7 GMP Manufactured Product

SODIUM DECANOATE

BET*, GMP, Excipient
Product Code: NDEC-3201

*Bioburden and Endotoxin Tested

Minimum Order Quantity: 5kg
Lead Time: 1-3 months

Product Inquiry COAs Spec Sheet

Click the button above for additional pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Please Use the Product Inquiry button (above) for bulk volumes.

Customer Service

First Name *

Last Name *

Company Name *

Position in Company

Email *

Company website

Company phone with country code *

Country where product is to be used *

Street Address *

City *

State *

Zip Code *

Country *

Additional Information Needed/Requested

Please Use the Product Inquiry button (above) for bulk volumes.

UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: NDEC-3201

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Sodium Decanoate, or Sodium Caprate, is the sodium salt of capric 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: C₁₀H₁₉NaO₂F.W.: 194.25 g/mol.

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

White to Off White Powder

Assay, Dried Basis

95.0 – 105.0%

Elemental Impurities

Complies with USP <232>

Endotoxin

< = 20.0 EU/g

Identification, IR

Conforms to Reference Standard

Impurities

Any Single Impurity

Sodium Octanoate (Octanoic Acid)

Sodium Nonanoate (Nonanoic Acid)

Total Impurities

< = 1.0%

Report

< = 3.0%

Iron (Fe)

Report

Loss on Drying

< = 5.0%

Microbial Content

TAMC

TYMC

< = 100 CFU/g

pH (10%)

9.0 - 11.0

Residual Solvents

Ethanol

< = 5000 ppm

Sodium Quantification

Report

Solubility

Passes Test

Water, KF

< = 5.0%

Printable Version

Key Product Features:

The manufacturing of Sodium Decanoate, NDEC-3201 is performed at BioSpectra’s Bangor, PA facility.
Appears as white to off-white powder
Manufactured in accordance with ICH Q7
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: Capric Acid; Sodium Caprate; Decanoic Acid

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

5kg, 10kg, and 25kg

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.