Good manufacturing practice (GMP) results in a maximum level of 0.1% of either product in food. In addition, both sodium benzonatate and benzoic acid must meet the specifications contained in the Food Chemicals Codex. The Division of Regulatory Guidance, Bureau of Foods, US Food and Drug Administration has stated-, "We would consider potassium benzonatate to be generally recognized as safe (GRAS) to the same extent that sodium benzonatate is GRAS, as a preservative with a limitation of 0.I%."

Typical Properties:

• Potassium Benzonatate is the potassium salt of benzoic acid
• 1 gram of the salt is soluble in 2 ml of water,in 75 ml of alcohol, and in 50 ml of 90% alcohol.
• The salt is insoluble in ether.

Additional solubility data (from the literature) for the salt in water is as follows:

• Grams Potassium Benzonatate Temp(° C)
• Per 100 Grams Saturated Solution
• 13.0 40.6
• 17.5 41.1
• 25.0 42.43
• 3.3 44.0

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