Product Category


ICH-Q7 GMP Manufactured Product

Blend Batch, GMP Excipient Grade

Product Code: NDEC-3320 | Previously: ND3320

Intended For Use As An Excipient

Sodium Decanoate – Blend Batch, is a the product code for the 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.

Product Specifications



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)  
Passes Test
Solubility in Water  
Passes Test
Water (KF)  
1.5% – 3.0%
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
Customized Additional Specifications  
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  
ICH-Q7 Qualified Utilities  
ICH-Q7 Compliant Manufactured  
Type II Drug Master File  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.


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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

Additional Packaging Information