Cat's Claw Tablets
» Cat's Claw Tablets contain Powdered Cat's Claw Extract. Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of Powdered Extract, calculated as pentacyclic oxindole alkaloids.
Packaging and storage Preserve in tight, light-resistant containers, and store at room temperature.
Labeling The label states the Latin binomial and, following the official name, the article from which Tablets were prepared. The label also indicates the quantity, in mg, of Powdered Extract per Tablet. Label Tablets to indicate the content, in mg, of pentacyclic oxindole alkaloids per 100 mg of Powdered Extract.
Identification The chromatogram of the Test solution exhibits peaks for speciophylline, uncarine F, mitraphylline, isomitraphylline, pteropodine, and isopteropodine at retention times that correspond to those in the chromatogram of Standard solution 1, as obtained in the test for Content of pentacyclic oxindole alkaloids and limit of tetracyclic oxindole alkaloids. The content of tetracyclic oxindole alkaloids, calculated as the sum of rhynchophylline and isorhynchophylline, is not more than 25% of the labeled amount of pentacyclic oxindole alkaloids.
Microbial enumeration 2021: meet the requirements of the tests for absence of Salmonella species and Escherichia coli. The total aerobic microbial count does not exceed 104 per g, and the total combined molds and yeasts count does not exceed 103 per g.
Disintegration 2040: meet the requirements for disintegration of botanical dosage forms.
Weight variation 2091: meet the requirements.
Content of pentacyclic oxindole alkaloids and limit of tetracyclic oxindole alkaloids
Solution A, Solution B, Solution C, Mobile phase, Standard solution 1, Standard solution 2, and Chromatographic system Proceed as directed in the test for Content of pentacyclic oxindole alkaloids and limit of tetracyclic oxindole alkaloids under Cat's Claw.
Test solution Weigh accurately not fewer than 20 Tablets, and pulverize, using a mortar and pestle. Transfer an accurately weighed quantity of the powder, equivalent to 20 mg of the labeled amount of pentacyclic oxindole alkaloids, to a 50-mL centrifuge tube. Sonicate with 10 mL of methanol for 10 minutes. Centrifuge, and transfer this solution to a 50-mL volumetric flask. Repeat the above extraction three additional times combining the extracts in the 50-mL volumetric flask, and dilute with methanol to volume. Transfer about 3 mL of the solution to a test tube containing 300 mg of polyamide powder, and shake for 1 minute. Pass through a nylon filter having a 0.45-µm or finer porosity, discarding the first part of the filtrate.
Procedure Proceed as directed in the test for Content of pentacyclic oxindole alkaloids and limit of tetracyclic oxindole alkaloids under Cat's Claw. Calculate the content of each relevant alkaloid, in mg, in the portion of Tablets taken by the formula:
50C(rU / rS)in which the terms are as defined therein. Calculate the content of total pentacyclic oxindole alkaloids by adding the individual contents of speciophylline, uncarine F, mitraphylline, isomitraphylline, pteropodine, and isopteropodine. Calculate the content of tetracyclic oxindole alkaloids by adding the individual contents of rhynchophylline and isorhynchophylline: not more than 25% of the labeled amount of pentacyclic oxindole alkaloids is found.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 973Pharmacopeial Forum: Volume No. 32(4) Page 1127
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.