Purified Honey is obtained by purification of honey from the comb of the bee, Apis mellifera L. and all subspecies of Apis mellifera. The honey is extracted by centrifugation, pressure, or other suitable procedures.
Sample solution: 1 in 20 solution
Standard solution: A 7.5 µg/mL solution of USP l-Proline RS
Samples: Standard solution and Sample solution
Place 0.5 mL of the Sample solution and the Standard solution in separate reaction vials, and add 0.25 mL of formic acid and 1.0 mL of freshly prepared 3% solution of ninhydrin in peroxide-free ethylene glycol monomethyl ether to each vial. Cap the reaction vials tightly, shake well, and place in boiling water for 15 min. Cool for 5 min in a 22 water bath, remove the caps, and add 5.0 mL of 5% aqueous isopropanol solution.
Acceptance criteria: The Sample solution shows a purple color similar to, or more intense than that of the Standard solution. If necessary, scan the solutions being compared using a suitable spectrophotometer against a water blank. The two solutions each exhibit a maximum at the same wavelength, at about 520 nm. The absorbance of the Sample solution should be at least as high as that of the Standard solution.
• Chloride and Sulfate, Chloride 221: A 1-g portion shows no more chloride than corresponds to 0.5 mL of 0.020 N hydrochloric acid (0.035%).
• Chloride and Sulfate, Sulfate 221: A 2-g portion shows no more sulfate than corresponds to 0.5 mL of 0.020 N sulfuric acid (0.024%).
• Articles of Botanical Origin, Total Ash 561: NMT 0.3%
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total bacterial count does not exceed 103 cfu/g. The total combined molds and yeasts count does not exceed 100 cfu/g.
• Specific Gravity 841: 1.4001.435 at 20
• Refractive Index 831: 1.49001.4992 at 20
• Water Determination, Method I 921: 15.0%18.6%
• Microbiological Procedures for Absence of Specified Microorganisms 2022: Where it is intended for use in preparations for infants under one year of age, it meets the requirements of the Test for Absence of Clostridium Species.
• Packaging and Storage: Preserve in tight containers. No storage requirements specified.
• Labeling: Label it to indicate that it is not intended for use in preparations for infants under one year of age, unless it meets the requirements of the Test for Absence of Clostridium Species.
• USP Reference Standards 11
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USP35NF30 Page 1817Pharmacopeial Forum: Volume No. 31(2) Page 496