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.
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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
(VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3120
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.