Amantadine Hydrochloride Syrup, chemical structure, molecular formula, Reference Standards

Amantadine Hydrochloride Syrup

(Current title—not to change until June 1,2005)

Monograph title change—to become official June 1,2005

See Amantadine Hydrochloride Oral Solution

»Amantadine Hydrochloride Syrup contains not less than 95.0percent and not more than 105.0percent of the labeled amount of amantadine hydrochloride (C10H17N·HCl).

Packaging and storage— Preserve in tight containers.

USP Reference standardsá11ñ— USP Amantadine Hydrochloride RS.

Identification,Infrared Absorption á197Sñ—

Cell: 1mm.

Solution— Place a volume of Syrup,equivalent to about 200mg of amantadine hydrochloride,in a vessel,dissolve in 0.1Nhydrochloric acid,and filter.Transfer the filtrate to a separator,add 10mLof 0.5Nsodium hydroxide,and extract with 5mLof methylene chloride.Filter the extract through anhydrous sodium sulfate,and rinse the anhydrous sodium sulfate with 2mLof methylene chloride.

Assay—

Internal standard solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Amantadine Hydrochloride Capsules.

Assay preparation— Pipet 5.0mLof the Syrup into a 250-mLconical flask,and add 45mLof 1.0Nsodium hydroxide and 50.0mLof Internal standard solution.Shake for 60minutes,and collect the hexane layer (Assay preparation).

Procedure— Proceed as directed in the Assayunder Amantadine Hydrochloride Capsules.Calculate the quantity,in mg,of C10H17N·HCl in the portion of Syrup taken by the formula:

50C(RU/RS),

in which Cis the concentration,in mg per mL,of USP Amantadine Hydrochloride RSin the Standard preparation;and RUand RSare the peak response ratios obtained from the Assay preparationand the Standard preparation,respectively.

Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 112

Pharmacopeial Forum:Volume No.28(2)Page 251

Phone Number:1-301-816-8394