Packaging and storage— Preserve in well-closed containers. No storage requirements specified.

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

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

Microbial limits 61— It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. The total aerobic microbial count does not exceed 1000 cfu per g, and the total combined molds and yeasts count does not exceed 100 cfu per g.

pH 791— Prepare a slurry by weighing 10.0 ± 0.1 g in 10 mL of alcohol and by diluting with water to 100 mL. Agitate continuously at a moderate rate for 5 minutes, then cease agitation, and immediately determine the pH to the nearest 0.1 unit: the pH is between 4.5 and 7.0, determined potentiometrically.

Loss on drying 731— Dry it at 120 for 4 hours: it loses not more than 14.0% of its weight.

Residue on ignition 281: not more than 0.5%, determined on a 2.0-g test specimen.

Iron 241— Dissolve the residue obtained in the test for Residue on ignition in 8 mL of hydrochloric acid with the aid of gentle heating, dilute with water to 100 mL, and mix. Dilute 25 mL of this solution with water to 47 mL: the limit is 0.002%.

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

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

Organic volatile impurities, Method IV 467: meets the requirements.

Residual solvents 467: meets the requirements.

Expert Committee : (EM205) Excipient Monographs 2

USP29–NF24 Page 3436

Phone Number : 1-301-816-8351