Isoproterenol Hydrochloride, chemical structure, molecular formula, Reference Standards

Isoproterenol Hydrochloride

C11H17NO3·HCl 247.72

1,2-Benzenediol,4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]-,hydrochloride.
3,4-Dihydroxy-a-[(isopropylamino)methyl]benzyl alcohol hydrochloride [51-30-9].

»Isoproterenol Hydrochloride contains not less than 97.0percent and not more than 101.5percent of C11H17NO3·HCl,calculated on the dried basis.

Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Isoproterenol Hydrochloride RS.

Identification—

A: Infrared Absorption á197Kñ.

B: Ultraviolet Absorption á197Uñ—

Solution: 50µg per mL.

Medium: water.

Melting range á741ñ: between 165

and 170

Loss on drying á731ñ— Dry about 1g,accurately weighed,in vacuum over phosphorus pentoxide for 4hours:it loses not more than 1.0%of its weight.

Residue on ignition á281ñ: not more than 0.2%.

Sulfate á221ñ— A0.10-g portion shows no more sulfate than corresponds to 0.20mLof 0.020Nsulfuric acid (0.2%).

Limit of isoproterenone— Its absorptivity (see Spectrophotometry and Light-scattering á851ñ)at 310nm,determined in a solution containing 2mg per mL,is not more than 0.2.

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Chloride content— Dissolve about 500mg,accurately weighed,in 5mLof water.Add 5mLof glacial acetic acid and 40mLof methanol.Add eosin Y TS,and titrate with 0.1Nsilver nitrate VS.Each mLof 0.1Nsilver nitrate is equivalent to 3.545mg of Cl.Between 13.9%and 14.6%of Cl is found,calculated on the dried basis.

Assay—

Standard preparation— Dissolve an accurately weighed quantity of USP Isoproterenol Hydrochloride RSin freshly prepared sodium bisulfite solution (3in 1000)to obtain a solution having a concentration of about 2.5mg per mL.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with 0.17Nacetic acid to volume,and mix to obtain a solution having a known concentration of about 250µg per mL.

Assay preparation— Transfer about 125mg of Isoproterenol Hydrochloride,accurately weighed,to a 25-mLvolumetric flask,dissolve in sodium bisulfite solution (3in 1000),dilute with sodium bisulfite solution to volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with 0.17Nacetic acid to volume,and mix.

Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 278-nm detector and a 30-cm ×4-mm stainless steel column that contains packing L1.The mobile phase is 0.17Nacetic acid having a flow rate of about 1.5mLper minute.Chromatograph five replicate injections of the Standard preparation,and record the peak responses as directed under Procedure:the relative standard deviation is not more than 3.0%.

Procedure— Using a microsyringe or sampling valve,chromatograph 10µLof the Standard preparation,and adjust the specimen size and other operating parameters,if necessary,until satisfactory chromatography and peak responses are obtained.Chromatograph equal volumes of the Standard preparationand the Assay preparation,and measure the peak responses.Calculate the quantity,in mg,of C11H17NO3·HCl in the portion of Isoproterenol Hydrochloride taken by the formula:

0.5C(hU/hS),

in which Cis the concentration,in µg per mL,of USP Isoproterenol Hydrochloride RSin the Standard preparation,and hUand hSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.

Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1078

Pharmacopeial Forum:Volume No.29(5)Page 1509

Phone Number:1-301-816-8379