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

Labeling— The label states the sodium content in terms of milliequivalents in a given volume,and states also the phosphorus content in terms of millimoles in a given volume.Label the Injection to indicate that it is to be diluted to appropriate strength with water or other suitable fluid prior to administration and that once opened any unused portion is to be discarded.The label states also the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,or where the label states that the Injection is not for direct injection but is to be diluted before use,the label alternatively may state the total osmolar concentration in mOsmol per mL.

USP Reference standards á11ñ— USP Endotoxin RS.

Identification— It responds to the tests for Sodium á191ñand for Phosphate á191ñ.

Bacterial endotoxins á85ñ— It contains not more than 1.10USP Endotoxin Units per mg of sodium phosphates.

Particulate matter á788ñ: meets the requirements under small-volume injections.

Other requirements— It meets the requirements under Injections á1ñ.

Assay for monobasic sodium phosphate— Transfer an accurately measured volume of Injection,equivalent to about 300mg of anhydrous monobasic sodium phosphate,to a 100-mLbeaker,and dilute with water to about 50mL.Place the electrodes of a suitable pHmeter in the solution,and titrate with 0.1Nsodium hydroxide VSto the inflection point to a pHof about 8.8.Each mLof 0.1Nsodium hydroxide is equivalent to 13.80mg of NaH2PO4·H2O.

Assay for dibasic sodium phosphate— Transfer an accurately measured volume of Injection,equivalent to about 300mg of anhydrous dibasic sodium phosphate,to a 100-mLbeaker,and dilute with water to about 50mL.Place the electrodes of a suitable pHmeter in the solution,and titrate with 0.1Nhydrochloric acid VSto the inflection point to a pHof about 4.0.Each mLof 0.1Nhydrochloric acid is equivalent to 26.81mg of Na2HPO4·7H2O.

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 1791

Phone Number:1-301-816-8251