Cat's Claw Capsules
» Cat's Claw Capsules contain Powdered Cat's Claw Extract. Capsules 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 the Capsules were prepared. If prepared with Extract, the label also indicates the quantity, in mg, of Extract per Capsule and 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 the contents of not fewer than 20 Capsules, 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 Capsules 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.
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Topic/Question Contact Expert Committee
Monograph Maged H. Sharaf, Ph.D.
Senior Scientist
1-301-816-8318
(DSB05) Dietary Supplements - Botanicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
2021 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 973
Pharmacopeial Forum: Volume No. 32(4) Page 1126
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.