Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass.

USP Reference standards á11ñ— USP Endotoxin RS.USP Glycine RS.

Identification— Evaporate a portion of Irrigation to dryness,and obtain the IRabsorption spectrum of a mineral oil dispersion of the residue:it exhibits maxima only at the same wavelengths as that of a similar preparation of USP Glycine RS.

Bacterial endotoxins á85ñ— It contains not more than 0.5Endotoxin Unit per mL.

pHá791ñ: between 4.5and 6.5,determined potentiometrically on a portion to which 0.3mLof saturated potassium chloride has been added for each 100mL.

Other requirements— It meets the requirements under Injections á1ñ,except that the container in which the solution is packaged may be designed to empty rapidly and may exceed 1000mLin capacity.

Assay— Dilute an accurately measured volume of Irrigation,equivalent to about 150mg of glycine,with water to 25mL,and add 10mLof formaldehyde TS,previously adjusted to a pHof 9.0,and 5drops of mixed indicator solution (prepared by dissolving 75mg of phenolphthalein and 25mg of thymol blue in a mixture of equal volumes of alcohol and water to make 100mL).Titrate with 0.1Nsodium hydroxide VSuntil the yellow color disappears and a faint violet color appears.Each mLof 0.1Nsodium hydroxide is equivalent to 7.507mg of glycine (C2H5NO2).

Expert Committee:(DSN)Dietary Supplements:Non-Botanicals

USP28–NF23Page 913

Phone Number:1-301-816-8389