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Novobiocin Sodium
C31H35N2NaO11 634.61

Benzamide, N-[7-[[3-O-(aminocarbonyl)-6-deoxy-5-C-methyl-4-O-methyl--L-lyxo-hexopyranosyl]oxy]-4-hydroxy-8-methyl-2-oxo-2H-1-benzopyran-3-yl]-4-hydroxy-3-(3-methyl-2-butenyl)-, monosodium salt.
Novobiocin, monosodium salt [1476-53-5].
» Novobiocin Sodium has a potency equivalent to not less than 850 µg of novobiocin (C31H36N2O11) per mg, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Identification—
A: Prepare a test solution by dissolving a quantity of it in methanol to obtain a concentration of about 1 mg of novobiocin per mL. Similarly prepare a Standard solution, using USP Novobiocin RS. Separately apply 1-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture, and allow the spots to dry. Place the plate in a chromatographic chamber equilibrated with a solvent system consisting of a mixture of chloroform, methanol, and ammonium hydroxide (75:25:1), and develop the chromatogram. When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and allow to dry. Locate the spots on the plate by examination under short-wavelength UV light: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
B: The residue obtained by igniting it responds to the tests for Sodium 191.
Specific rotation 781S: between 50 and 58.
Test solution: 50 mg per mL, in a mixture of methanol and hydrochloric acid (100:1).
Crystallinity 695: meets the requirements.
pH 791: between 6.5 and 8.5, in a solution containing 25 mg per mL.
Loss on drying 731— Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 6.0% of its weight.
Residue on ignition 281: between 10.5% and 12.0%, the charred residue being moistened with 2 mL of sulfuric acid and an ignition temperature of 550 ± 50 being used.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve a suitable quantity of Novobiocin Sodium, accurately weighed, in an accurately measured volume of Buffer No. 3 sufficient to obtain a stock solution of convenient concentration. Proceed as directed under Antibiotics—Microbial Assays 81, using an accurately measured volume of this stock solution diluted quantitatively and stepwise with Buffer No. 6 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison : Ian DeVeau, Ph.D., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 1566
Phone Number : 1-301-816-8178