Powdered Cat's Claw Extract
» Powdered Cat's Claw Extract is prepared from Cat's Claw by extraction with hydroalcoholic mixtures or other suitable solvents. The ratio of plant material to extract is between 4:1 and 6:1. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of pentacyclic oxindole alkaloids, calculated on the dried basis, as the sum of speciophylline, uncarine F, mitraphylline, isomitraphylline, pteropodine, and isopteropodine. It may contain suitable added substances.
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 part of the plant from which the article was prepared. The label also indicates the content of pentacyclic oxindole alkaloids, the extracting solvent or solvent mixture used for preparation, and the ratio of the starting crude plant material to Powdered Extract. It meets the requirements for Labeling under Botanical Extracts 565.
A: Thin Layer Chromatographic Identification Test 201
Standard solution, Developing solvent system, Spray reagent A, Spray reagent B, and Procedure Proceed as directed for Thin-Layer Chromatographic Identification Test 201 under Cat's Claw.
Test solution Shake a quantity of Powdered Extract, equivalent to 25 mg of the labeled amount of pentacyclic oxindole alkaloids, in 20 mL of methanol. Allow to stand for 15 minutes before use.
B: 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 sum of the peak areas for the tetracyclic oxindole alkaloids rhynchophylline and isorhynchophylline is less than 25% of the total peak areas detected for pentacyclic oxindole alkaloids.
Microbial enumeration 2021: meets 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.
Loss on drying 731 Dry 1g at 105 for 2 hours: it loses not more than 10.0% of its weight.
Heavy metals, Method II 231: not more than 10 µg per g.
Content of pentacyclic oxindole alkaloids and limit of tetracyclic oxindoles
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 oxindoles under Cat's Claw.
Test solution Transfer an accurately weighed quantity of Powdered Extract, equivalent to about 5 mg of the labeled content of pentacyclic oxindole alkaloids, to a 10-mL centrifuge tube. Add 2.5 mL of methanol, and sonicate for 10 minutes. Centrifuge, and transfer the supernatant to a 10-mL volumetric flask. Repeat the above extraction three additional times combining the extracts in the 10-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. Separately calculate the percentage of each relevant alkaloid in the portion of Powdered Extract taken by the formula:
(C/W)(rU / rS)in which W is the weight, in g, of Powdered Extract taken to prepare the Test solution; and the other terms are as defined therein. Calculate the percentage of pentacyclic oxindole alkaloids in the Powdered Extract taken by adding the individual percentages of speciophylline, uncarine F, mitraphylline, isomitraphylline, pteropodine, and isopteropodine. Calculate the percentage of tetracyclic oxindole alkaloids in the Powdered Extract taken by adding the individual percentages of rhynchophylline and isorhynchophylline: not more than 25% of the labeled amount of pentacyclic oxindole alkaloids is found.
Other requirements It meets the requirements for Residual Solvents and Pesticide Residues under Botanical Extracts 565.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 972Pharmacopeial Forum: Volume No. 32(4) Page 1124
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.