Packaging and storage— Preserve in well-closed containers.

Labeling— Label it to indicate the botanical source from which it was derived.

Identification— Awater slurry of it is colored orange red to deep blue by iodine TS.

Microbial limits á61ñ— It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.The total aerobic microbial count does not exceed 1000cfu per g,and the total combined molds and yeasts count does not exceed 1000cfu per g.

pHá791ñ— Prepare a slurry by weighing 10.0±0.1g in 10mLof alcohol and by diluting with water to 100mL.Agitate continuously at a moderate rate for 5minutes,then cease agitation,and immediately determine the pHto the nearest 0.1unit:the pHis between 4.5and 7.0,determined potentiometrically.

Loss on drying á731ñ— Dry it at 120for 4hours:it loses not more than 14.0%of its weight.

Residue on ignition á281ñ: not more than 0.5%,determined on a 2.0-g test specimen.

Iron á241ñ— Dissolve the residue obtained in the test for Residue on ignitionin 8mLof hydrochloric acid with the aid of gentle heating,dilute with water to 100mL,and mix.Dilute 25mLof this solution with water to 47mL:the limit is 0.002%.

Oxidizing substances— To 5g add 20mLof a mixture of equal volumes of methanol and water,then add 1mLof 6Nacetic acid,and stir until a homogeneous suspension is obtained.Add 0.5mLof a freshly prepared,saturated solution of potassium iodide,mix,and allow to stand for 5minutes:no distinct blue,brown,or purple color is observed.

Limit of sulfur dioxide— Mix 20g with 200mLof a 1in 5solution of anhydrous sodium sulfate,and filter.To 100mLof the clear filtrate add 3mLof starch TS,and titrate with 0.01Niodine VSto the first permanent blue color:not more than 2.7mLis consumed (0.008%).

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 3088

Phone Number:1-301-816-8323