Cycloserine Capsules
» Cycloserine Capsules contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cycloserine (C3H6N2O2).
Packaging and storage
Preserve in tight containers.
USP Reference standards 11
USP Cycloserine RS.
Identification
Shake a quantity of the contents of Capsules, equivalent to about 10 mg of cycloserine, with 100 mL of 0.1 N sodium hydroxide, and filter: 1 mL of the filtrate so obtained responds to the Identification test under Cycloserine.
Dissolution 711
Medium:
pH 6.8 Phosphate buffer (see Buffer Solutions under Solutions in the section Reagents, Indicators, and Solutions); 900 mL.
Apparatus 1:
100 rpm.
Time:
30 minutes.
Determine the amount of C3H6N2O2 dissolved by employing the following method.
pH 6.8 Phosphate buffer, Mobile phase, and Chromatographic system
Proceed as directed in the Assay.
Standard solution
Quantitatively dissolve an accurately weighed quantity of USP Cycloserine RS in pH 6.8 Phosphate buffer to obtain a solution having a known concentration of about 0.25 mg per mL.
Test solution
Use a filtered portion of the solution under test.
Procedure
Separately inject equal volumes (about 10 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses for cycloserine. Calculate the quantity, in mg, of cycloserine (C3H6N2O2) dissolved by the formula:
900C(rU / rS)
in which C is the concentration, in mg per mL, of USP Cycloserine RS in the Standard solution; and rU and rS are the peak responses for cycloserine obtained from the Test solution and the Standard solution, respectively.
Tolerances
Not less than 80% (Q) of the labeled amount of C3H6N2O2 is dissolved in 30 minutes.
Uniformity of dosage units 905:
meet the requirements.
Loss on drying 731
Dry about 100 mg of the contents of Capsules in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 1.0% of its weight.
Assay
pH 6.8 Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system
Proceed as directed in the Assay under Cycloserine.
Assay preparation
Remove, as completely as possible, the contents of not fewer than 20 Capsules. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of cycloserine, to a 250-mL volumetric flask, dilute with pH 6.8 Phosphate buffer to volume, mix, and filter.
Procedure
Proceed as directed in the Assay under Cycloserine. Calculate the quantity, in mg, of cycloserine (C3H6N2O2) in the portion of Capsules taken by the formula:
250C(rU / rS)
in which the terms are as defined therein.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 2043
Pharmacopeial Forum: Volume No. 28(3) Page 750
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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