ICH-Q7 GMP Manufactured Product
ANALYSIS |
SPECIFICATIONS |
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White to off-white powder | ||
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95.0% – 105.0% | ||
Elemental Impurities | Complies with USP <232> | ||
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Matches the reference | ||
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≤ 1.0% Report Report ≤ 3.0% |
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Report |
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5.0% max. |
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9.0-11.0 | ||
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≤ 5000 ppm | ||
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Report | ||
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Passes Test | ||
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≤ 5.0% |
Printable Version
Bio Excipient Grade Sodium Decanoate NDEC-3201 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.
The recommended retest period for Sodium Decanoate is two years from the date of manufacture.
Ship and Store between 2°C and 8°C. Store in a clean and dry area. Store in the original container.
1 kg bottle, 5 kg, 10 kg and 25 Kg pails
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.