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

Labeling— The label states the content of ammonium chloride in terms of weight and of milliequivalents in a given volume.The label states also the total osmolar concentration in mOsmol per Lor per mL.The label states that the Injection is not for direct injection but is to be diluted with Sodium Chloride Injection to the appropriate strength before use.

USP Reference standards á11ñ— USP Endotoxin RS.

Identification— It responds to the tests for Ammonium á191ñand for Chloride á191ñ.

Bacterial endotoxins á85ñ— It contains not more than 1.72USP Endotoxin Units per mEq of chloride.

pHá791ñ: between 4.0and 6.0,in a concentration of not more than 100mg of ammonium chloride per mL.

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

Chloride content— Transfer an accurately measured volume of Injection,evaporated,if necessary,equivalent to about 2g of ammonium chloride,to a 200-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLof this solution to a conical flask,add 10mLof glacial acetic acid,75mLof methanol,and 0.5mLof eosin Y TS.Titrate,with shaking,with 0.1Nsilver nitrate VSto a pink endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 3.545mg of Cl.The content of Cl is between 63.0%and 70.3%of the labeled amount of ammonium chloride.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Transfer an accurately measured volume of Injection,equivalent to about 200mg of ammonium chloride,to a 500-mL Kjeldahl flask,dilute with water to 200mL,mix,and add 50mLof sodium hydroxide solution (2in 5).Immediately connect the flask by means of a distillation trap to a well-cooled condenser,the delivery tube of which dips into 40mLof boric acid solution (1in 25)contained in a suitable receiver.Heat to boiling,and distill about 200mL.Cool the liquid in the receiver,if necessary,then add methyl red TS,and titrate with 0.1Nsulfuric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsulfuric acid is equivalent to 5.349mg of NH4Cl.

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 137

Phone Number:1-301-816-8251