Novobiocin Sodium
C31H35N2NaO11
634.61
Benzamide,N-[7-[[3-O-(aminocarbonyl)-6-deoxy-5-C-methyl-4-O-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 [1476-53-5].
»Novobiocin Sodium has a potency equivalent to not less than 850µg 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 1mg of novobiocin per mL.Similarly prepare a Standard solution,using USP Novobiocin RS.Separately apply 1-µLportions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)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 UVlight:the RFvalue 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 á191ñ.
Specific rotation á781Sñ:
between -50
and -58.
and -58.
Test solution:
50mg per mL,in a mixture of methanol and hydrochloric acid (100:1).
Crystallinity á695ñ:
meets the requirements.
pHá791ñ:
between 6.5and 8.5,in a solution containing 25mg per mL.
Loss on drying á731ñ—
Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 6.0%of its weight.
for 3hours:it loses not more than 6.0%of its weight.
Residue on ignition á281ñ:
between 10.5%and 12.0%,the charred residue being moistened with 2mLof sulfuric acid and an ignition temperature of 550±50being used.
being used.
Assay—
Dissolve a suitable quantity of Novobiocin Sodium,accurately weighed,in an accurately measured volume of Buffer No.3sufficient to obtain a stock solution of convenient concentration.Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this stock solution diluted quantitatively and stepwise with Buffer No.6to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information—
Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1406
Phone Number:1-301-816-8178