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201 by ebsc0sa on Tue Dec 24 15:29:37 EST 2013
1956 Betamethasone / Official Monographs
Internal standard solution—Prepare a solution of propyl-
paraben in alcohol having a known concentration of about
0.25 mg per mL.
Standard preparation—Dissolve an accurately weighed
quantity of USP Betamethasone RS in alcohol to obtain a
solution having a known concentration of about 0.2 mg per
mL. Transfer 10.0 mL of this solution to a suitable vial, and
add 10.0 mL of Internal standard solution, to obtain a Stan-
dard preparation having known concentrations of about
0.1 mg of betamethasone and about 0.125 mg of propyl-
paraben per mL.
Assay preparation—Using about 80 mg of Betameth-
asone, accurately weighed, prepare as directed for Standard
preparation.
Chromatographic system (see Chromatography 〈621〉)—The
liquid chromatograph is equipped with a 240-nm detector
and a 4.6-mm × 25-cm column that contains packing L1.
The flow rate is about 1.0 mL per minute. Chromatograph
the Standard preparation, and record the peak responses as
directed for Procedure: the relative retention times are about
1.0 for betamethasone and 1.4 for propylparaben; the reso-
lution, R, between betamethasone and propylparaben is not
less than 3.0; and the relative standard deviation for repli-
cate injections is not more than 2.0%.
Procedure—Separately inject equal volumes (about 10 µL)
of the Standard preparation and the Assay preparation into
the chromatograph, record the chromatograms, and meas-
ure the responses for the major peaks. Calculate the quan-
tity, in mg, of C22H29FO5 in the portion of Betamethasone
taken by the formula:
800C(RU / RS)
in which C is the concentration, in mg per mL, of USP
Betamethasone RS in the Standard preparation; and RU and
RS are the peak height ratios of the betamethasone peak
and the internal standard peak obtained from the Assay
USP Monographs
preparation and the Standard preparation, respectively.
.
Betamethasone Cream
DEFINITION
Betamethasone Cream contains NLT 90.0% and NMT
115.0% of the labeled amount of betamethasone
(C22H29FO5) in a suitable cream base.
IDENTIFICATION
• A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST
〈201〉
Standard solution: 1 mg/mL of USP Betamethasone RS
in dehydrated alcohol
Sample solution: Nominally 1 mg/mL of
betamethasone prepared by concentrating 10 mL of the
Sample solution from the Assay on a steam bath to 1 mL
Chromatographic system
Developing solvent system: Chloroform and diethyl-
amine (2:1)
Spray reagent: Methanol, sulfuric acid, and nitric acid
(10:10:1)
Analysis
Samples: Standard solution and Sample solution
Proceed as directed in the chapter, except spray the
plate with the Spray reagent, and heat at 105° for 10
min.
Acceptance criteria: Meets the requirements
ASSAY
• PROCEDURE
Mobile phase: Acetonitrile and water (37:63)
Internal standard solution: 0.25 mg/mL of propylpara-
ben in alcohol
Official from May 1, 2014
Copyright (c) 2013 The United States Pharmacopeial Convention. All rights reserved.
USP 37
Standard stock solution: 0.2 mg/mL of USP
Betamethasone RS in alcohol
Standard solution: 0.1 mg/mL of USP Betamethasone
RS prepared by combining 10.0 mL of the Internal stan-
dard solution and 10.0 mL of the Standard stock solution
Sample solution: Nominally 0.1 mg/mL of
betamethasone prepared as follows. To a portion of
Cream, nominally equivalent to 2 mg of
betamethasone, add 10.0 mL of Internal standard solu-
tion and 10.0 mL of alcohol. Mix by rotation for 20
min. Centrifuge at 2500 rpm for 10 min. Transfer a
portion of the supernatant to a suitable vial.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 240 nm
Column: 4.6-mm × 25-cm; packing L1
Flow rate: 1 mL/min
Injection volume: 10 µL
System suitability
Sample: Standard solution
[NOTE—The relative retention times for betamethasone
and propylparaben are 1.0 and 1.4, respectively.]
Suitability requirements
Resolution: NLT 3.0 between betamethasone and
propylparaben
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of
betamethasone (C22H29FO5) in the portion of Cream
taken:
Result = (RU/RS) × (CS/CU) × 100
RU = peak height ratio of the betamethasone peak
to the internal standard peak from the
Sample solution
RS = peak height ratio of the betamethasone peak
to the internal standard peak from the
Standard solution
CS = concentration of USP Betamethasone RS in the
Standard solution (mg/mL)
CU = nominal concentration of betamethasone in
the Sample solution (mg/mL)
Acceptance criteria: 90.0%–115.0%
PERFORMANCE TESTS
• MINIMUM FILL 〈755〉: Meets the requirements
SPECIFIC TESTS
• MICROBIAL ENUMERATION TESTS 〈61〉 and TESTS FOR SPECI-
FIED MICROORGANISMS 〈62〉: It meets the requirements of
the tests for the absence of Staphylococcus aureus and
Pseudomonas aeruginosa.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in collapsible tubes or
in tight containers.
• USP REFERENCE STANDARDS 〈11〉
USP Betamethasone RS
.
Betamethasone Oral Solution
DEFINITION
Betamethasone Oral Solution contains NLT 90.0% and NMT
115.0% of the labeled amount of betamethasone
(C22H29FO5).