Novobiocin Sodium
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
C31H35N2NaO11 634.61
Benzamide, N-[7-[[3-0-(aminocarbonyl)-6-deoxy-5-C-methyl-4-0-methyl-B-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 CAS RN: 1476-53-5; UNII: Q9S9NQ5YIY.
Novobiocin Sodium has a potency equivalent to not less than 850 µg of novobiocin (C31H35N2O11) per mg, calculated on the dried basis.
Packaging and storage-Preserve in tight containers.
USP REFERENCE STANDARDS (11)-
USP Novobiocin RS
1 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 R, 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.
2 Assay
Dissolve a suitable quantity of Novobiocin Sodium, accurately weighed, in an accurately measured volume of Buffer B.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 B.6 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
