Ginger Capsules
» Ginger Capsules are prepared from Powdered Ginger and contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of gingerols, gingerdiones, and shogaols, and not less than 90.0 percent of the labeled amount of volatile oil.
Packaging and storage
Preserve in well-closed containers, and store at controlled 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 gingerols, gingerdiones, and shogaols, in mg per Capsule, and the content of volatile oil, in µL per Capsule.
USP Reference standards 11
USP Capsaicin RS. USP Ginger Constituent Mixture RS. USP Powdered Ginger RS.
Dissolution 2040
Medium:
0.1 N hydrochloric acid; 500 mL.
Apparatus 2:
75 rpm.
Time:
60 minutes.
noteIn each dissolution vessel, place a number of Capsules equivalent to about 20 mg of the labeled amounts of gingerols, gingerdiones, and shogaols.
Mobile phase
Prepare as directed in the test for Content of gingerols and gingerdiones under Ginger.
Standard stock solution
Use the Standard preparation, prepared as directed in the test for Content of gingerols and gingerdiones under Ginger.
Standard solution
Transfer 1.0 mL of the Standard stock solution to a 10-mL volumetric flask, and dilute with Medium to volume to obtain a solution having a known concentration of about 0.025 mg of USP Capsaicin RS per mL.
Test solution
Transfer an aliquot of solution from each dissolution vial to a suitable vial. Allow to stand for 5 minutes so the powder settles into the suspension, or centrifuge to obtain a clear supernatant. Pass through a membrane filter having a 0.45-µm or finer porosity.
Chromatographic system
Proceed as directed in the test for Content of gingerols and gingerdiones under Ginger. To evaluate the system suitability requirements, use the Standard preparation and the System suitability solution, prepared as directed in the test for Content of gingerols and gingerdiones under Ginger.
Procedure
Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, and allow the Test solution to elute for not less than three times the retention time of capsaicin. Record the chromatograms, and measure all of the peak responses. Calculate the quantity, in mg, of 6-gingerol dissolved, G, from each Capsule taken by the formula:
500(C/N)(rU / rS)
in which C is the concentration, in mg per mL, of USP Capsaicin RS in the Standard solution; N is the number of Capsules in each vessel; rU is the peak response for 6-gingerol obtained from the Test solution; and rS is the peak response for capsaicin obtained from the Standard solution. Calculate the percentage of the relative amount of 6-gingerol dissolved by the formula:
100(G/G0)
in which G0 is the content of 6-gingerol, in mg, in each Capsule, as determined in the test for Content of gingerols, gingerdiones, and shogaols.
Tolerances
Not less than 60% of the content of 6-gingerol (C17H26O4) is dissolved in 60 minutes.
Weight variation 2091:
meet the requirements.
Volatile oil content 561
Weigh and finely powder a quantity of Capsules, equivalent to about 100 g of powdered ginger: not less than 1.4 mL per 100 g is found.
Content of gingerols, gingerdiones, and shogaols
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system
Proceed as directed in the test for Content of gingerols and gingerdiones under Ginger.
Test preparation
Mix and finely powder the content of not fewer than 20 Capsules, and transfer an accurately weighed amount of the powder, equivalent to about 2.0 g of powdered ginger, to a glass-stoppered conical flask. Add 50 mL of alcohol, insert a stopper into the flask, and macerate for 24 hours, shaking frequently during the first 8 hours, and then allowing to stand for 18 hours. Filter, and use the filtrate.
Procedure
Proceed as directed in the test for Content of gingerols and gingerdiones under Ginger. Calculate the amounts, in mg, of gingerols, gingerdiones, and shogaols in the portion of the Capsules taken by the formula:
50C(rU / rS)
in which C is the concentration, in mg per mL, of USP Capsaicin RS in the Standard preparation; rU is the sum of peak responses for gingerols, gingerdiones, and shogaols; and rS is the peak response for capsaicin obtained from the Standard preparation. Calculate the amount (G0), in mg, of 6-gingerol in each Capsule by the formula:
50C/W(rU / rS)A
in which rU is the peak response for 6-gingerol obtained from the Test preparation; W is the weight of powdered ginger, in g, used in the Test preparation; A is the average Capsule fill weight, in g; and the other terms are as defined above.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1016
Pharmacopeial Forum: Volume No. 32(1) Page 163
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