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5914-5916 Beta Carotene PDF
5914-5916 Beta Carotene PDF
ADDITIONAL REQUIREMENTS Analysis: Record the UV-Vis spectrum from 300600 nm.
PACKAGING AND STORAGE: Preserve as described under Acceptance criteria: The Sample solution shows a shoul-
Injections 1, Containers for Sterile Solids. Store at der at about 427 nm, an absorption maximum at about
controlled room temperature. 455 nm, and another maximum at about 483 nm. The
LABELING: It meets the requirements for Injections 1, absorbance ratio A455/A483 is 1.141.18.2S (USP35)
Labeling.
Change to read:
Change to read:
B. The retention time of the major peak of the Sample
USP REFERENCE STANDARDS 11 solution corresponds to that of the Standard solution, as ob-
USP Azaerythromycin A RS tained in the Content of Beta Carotene.2S (USP35)
9-Deoxo-9a-aza-9a-homoerythromycin A.
C37H70N2O12 734.96 ASSAY
USP Azithromycin RS
USP Azithromycin N-Oxide RS Delete the following:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl--L-ribo- PROCEDURE
hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy- [NOTEPerform this procedure in subdued light, using
3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- low-actinic glassware.]
(dimethylazinoyl)--D-xylo-hexopyranosyl]oxy]-1-oxa-6- Sample stock solution: Dissolve 50 mg of Beta Carotene
azacyclopentadecan-15-one. in 10 mL of acid-free chloroform in a 100-mL volumetric
C38H72N2O13 764.98 flask. Dilute with cyclohexane to volume. Pipet 5 mL into
USP N-Demethylazithromycin RS a 100-mL volumetric flask, and dilute with cyclohexane.
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6- Sample solution: Sample stock solution with cyclohexane
Dideoxy-3-C-methyl-3-O-methyl--L-ribo- (1 in 10)
hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy- Spectrometric conditions
3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3- Analytical wavelength: 455 nm
methylamino--D-xylo-hexopyranosyl]oxy]-1-oxa-6- Blank: Cyclohexane
azacyclopentadecan-15-one. Analysis
C37H70N2O12 734.96 Samples: Sample solution and Blank
USP Desosaminylazithromycin RS Determine the absorbance of Sample solution using the
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-
Blank. Calculate the percentage of C40H56 in the portion
3,4,10,13-tetrahydroxy-3,5,6,8,10,12,14-heptamethyl- of Beta Carotene taken:
11-[[3,4,6-trideoxy-3-dimethylamino--D-xylo-
hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15- Result = [(400 AU)/AS] 100
one.
C30H58N2O9 590.792S (USP35) AU = absorbance of the Sample solution
USP Endotoxin RS AS = absorptivity of pure beta carotene, 250
Acceptance criteria: 96.0%101.0%2S (USP35)
COMPOSITION
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