Sodium Decanoate

BIO EXCIPIENT GRADE / ND3220

INTENDED FOR USE AS AN EXCIPIENT

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BIO EXCIPIENT GRADE / ND3220

CAS #: 1002-62-6

Molecular Formula:

C10H19NaO2

Solubility in Water (g/L): 0.1

F.W.: 194.25 g/mol.

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.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

 

ANALYSIS

SPECIFICATIONS

Appearance  
White to Off-White Crystalline Powder
Assay (Dried basis)  
95.0% – 105.0%
Identification (IR)  
Matches the reference
Loss on Drying  

3.0% max.

pH (10%)  

9.0 – 11.0

Single Impurities (GC)  
≤1.0%
Total Impurities (GC)  
≤3.0%
Sodium  
Passes Test
Solubility in Water  
Passes Test
Water (KF)  
≤5.0%
Printable Version

Key Compliance Attributes of

BioSpectra Grades

Bio ExcipientGrade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
 

General Product Description:

  • The manufacturing of Sodium Decanoate ND3220 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
  • BioSpectra certifies that all Sodium Decanoate ND3220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

General Product Description:

  • BioSpectra certifies that all Sodium Decanoate ND3220 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 ND3220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. This Grade of Sodium Decanoate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item. 

Expiration/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