Cyclosporine Oral Solution

» Cyclosporine Oral Solution is a solution of Cyclosporine in a suitable vehicle. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cyclosporine (C62H111N11O12).

Packaging and storage— Preserve in tight containers.

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USP Cyclosporine RS

Identification—

A: Using a solution of it in a mixture of methanol and chloroform (4:1) containing about 1 mg of cyclosporine per mL (test solution) and a Standard solution containing 1 mg of USP Cyclosporine RS in the same solvent mixture, proceed as directed in Identification test A under Cyclosporine Injection, beginning with “Separately apply 10-µL portions of the test solution”: the Oral Solution meets the requirements of the test.

B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Uniformity of dosage units

905

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for oral solution packaged in single-unit containers: meets the requirements.

Deliverable volume

698

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for oral solution packaged in multiple-unit containers: meets the requirements.

Alcohol content (where present)—

Internal standard solution, Chromatographic system, and System suitability— Proceed as directed in the test for Alcohol content under Cyclosporine Injection.

Standard stock solution— Transfer about 2.5 g of dehydrated alcohol, accurately weighed, to a 50-mL volumetric flask, dilute with butyl alcohol to volume, and mix.

Standard preparation— Transfer 5.0 mL of Standard stock solution and 6.0 mL of Internal standard solution to a 25-mL volumetric flask, dilute with butyl alcohol to volume, and mix.

Test preparation— Transfer an accurately weighed portion of Oral Solution, equivalent to about 250 mg of C2H5OH, to a 25-mL volumetric flask, add 6.0 mL of Internal standard solution, dilute with butyl alcohol to volume, and mix.

Procedure— Proceed as directed for Procedure in the test for Alcohol content under Cyclosporine Injection. Calculate the quantity, in mg, of C2H5OH in the portion of Oral Solution taken by the formula:

25C(RU / RS)

in which the terms are as defined therein: between 80.0% and 120.0% of the labeled amount of C2H5OH is found.

Assay—

Mobile phase— Prepare as directed in the Assay under Cyclosporine Injection.

Solvent mixture— Prepare a mixture of methanol and chloroform (4:1).

Standard preparation— Dissolve an accurately weighed quantity of USP Cyclosporine RS in Solvent mixture to obtain a solution having a known concentration of about 1 mg per mL. Use this solution promptly after preparation.

Assay preparation— Quantitatively dilute an accurately measured volume of Oral Solution with Solvent mixture to obtain a solution containing about 1 mg of cyclosporine per mL. Use this solution promptly after preparation.

Chromatographic system— Proceed as directed for Chromatographic system in the Assay under Cyclosporine Injection, except to maintain the column at 50

instead of 70

Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of cyclosporine (C62H111N11O12) in each mL of the Oral Solution taken by the formula:

(L/D)(CP/1000)(rU / rS)

in which L is the labeled quantity, in mg, of cyclosporine in each mL of Oral Solution taken; D is the concentration, in mg per mL, of the Assay preparation, based on the labeled quantity of cyclosporine in the volume of Oral Solution taken and the extent of dilution; C is the concentration, in mg per mL, of USP Cyclosporine RS in the Standard preparation; P is the purity, in µg per mg, of USP Cyclosporine RS; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Ahalya Wise, M.S. Senior Scientific Liaison 1-301-816-8161	(SM12010) Monographs - Small Molecules 1
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP35–NF30 Page 2796

Pharmacopeial Forum: Volume No. 30(1) Page 92