Sodium Decanoate
BIO EXCIPIENT GRADE / ND3220
INTENDED FOR USE AS AN EXCIPIENT
BIO EXCIPIENT GRADE / ND3220
CAS #: 1002-62-6
Molecular Formula:
C10H19NaO2
Solubility in Water (g/L): 0.1
F.W.: 194.25 g/mol.
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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.
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ANALYSIS |
SPECIFICATIONS |
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White to Off-White Powder | ||
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97.0% – 103.0% | ||
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Passes Test | ||
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3.0% max. |
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9.0 – 11.0 |
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<1.0% | ||
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Passes Test | ||
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Passes Test | ||
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1.5% – 3.0% |
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Key Compliance Attributes of BioSpectra Grades |
Bio ExcipientGrade ICH Q7 Compliant Manufactured | ||
|---|---|---|---|
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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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