Cycloserine Capsules
»Cycloserine Capsules contain not less than 90.0percent and not more than 120.0percent of the labeled amount of cycloserine (C3H6N2O2).
Packaging and storage— Preserve in tight containers.
Identification— Shake a quantity of the contents of Capsules,equivalent to about 10mg of cycloserine,with 100mLof 0.1Nsodium hydroxide,and filter:1mLof the filtrate so obtained responds to the Identificationtest under Cycloserine.
Dissolution á711ñ
Medium: pH6.8Phosphate buffer(see Buffer Solutionsunder Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Determine the amount of C3H6N2O2dissolved by employing the following method.
pH6.8Phosphate buffer,Mobile phase,and Chromatographic system— Proceed as directed in the Assay.
Standard solution— Quantitatively dissolve an accurately weighed quantity of USP Cycloserine RSin pH6.8Phosphate bufferto obtain a solution having a known concentration of about 0.25mg per mL.
Test solution— Use a filtered portion of the solution under test.
Procedure— Separately inject equal volumes (about 10µL)of the Standard solutionand the Test solutioninto 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 Cis the concentration,in mg per mL,of USP Cycloserine RSin the Standard solution;and rUand rSare 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 C3H6N2O2is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Loss on drying á731ñ Dry about 100mg of the contents of Capsules in a capillary-stoppered bottle in vacuum at 60for 3hours:it loses not more than 1.0%of its weight.
Assay—
pH6.8Phosphate buffer,Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Cycloserine.
Assay preparation— Remove,as completely as possible,the contents of not fewer than 20Capsules.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of cycloserine,to a 250-mLvolumetric flask,dilute with pH6.8Phosphate bufferto volume,mix,and filter.
Procedure— Proceed as directed in the Assayunder 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— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 561
Pharmacopeial Forum:Volume No.28(3)Page 750
Phone Number:1-301-816-8335