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LevothyroxineSodium
C15H10I4NNaO4xH2O(anhydrous)
798.85
L-Tyrosine,O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-,monosodiumsalt,hydrate.
Monosodium L-thyroxinehydrate [25416-65-3].
Anhydrous [55-03-8].
LevothyroxineSodiumisthesodiumsaltofthelevoisomerofthyroxine,an
activephysiologicalprincipleobtainedfromthethyroidglandofdomesticated
animalsusedforfoodbymanorpreparedsynthetically.Itcontainsnotless
than97.0percentandnotmorethan103.0percentofC15H10I4NNaO4,
calculatedontheanhydrousbasis.
Packaging and storagePreserveintightcontainers,protectedfromlight.
USP Reference standards
USP Levothyroxine RS.
USP Liothyronine RS.
11
Identification
A: Igniteabout50mginaplatinumdishoveraflame:itdecomposesandliberatesiodinevapors.
B: Toabout0.5mgadd7.5mLofacidsodiumchloridesolution(preparedbymixing300mLof
water,250mLofalcohol,100mLof1Nsodiumhydroxide,and100mLofhydrochloricacid)and
1mLofsodiumnitritesolution(1in100).Allowtostandinthedarkfor20minutes,andadd1.25
mLofammoniumhydroxide:apinkcolorisproduced.
Specific rotation
Test solution:anamountequivalentto30mgofanhydrousLevothyroxineSodiumpermL,ina
mixtureofalcoholand1Nsodiumhydroxide(2:1).
Water, Method III
921 Dryabout500mg,accuratelyweighed,overphosphoruspentoxide
at60 andatapressurenotexceeding10mmofmercuryfor4hours:itlosesnotmorethan
11.0%ofitsweight.
Limit of inorganic iodides
Extracting solutionPreparea1in100solutionofsulfuricacidinwater.
Reference solutionDissolveanaccuratelyweighedquantityofpotassiumiodideinwaterto
obtainastocksolutioncontaining0.131mg,equivalentto0.100mgofiodidepermL.Transfer0.6
mLofthisstocksolutionintoa1000-mLvolumetricflask,dilutewiththe Extracting solutionto
volume,andmix.EachmLoftheReference solutioncontains0.06gofiodide.[ NOTEPrepare
thissolutiononthedayofuse.]
Test solutionTransfer7.5mgofLevothyroxineSodiumtoabeaker,add100mLofthe
Extracting solution,andsonicatefor5minutes.
Electrode systemUseaniodide-specific,ion-indicatingelectrodeandasilver-silverchloride
referenceelectrodeconnectedtoapHmetercapableofmeasuringpotentialswithaminimum
reproducibilityof1mV(seepH
791 ).
ProcedureTransfertheReference solutiontoabeakercontainingamagneticstirringbar.Rinse
anddrytheelectrodes,insertinthesolution,stirfor5minutesoruntilthereadingstabilizes,and
readthepotential,inmV.Repeatthisprocessusingthe Test solution.Therequirementsofthe
testaremetiftheTest solutionhasahigherpotential,inmV,thantheReference solution:thelimit
is0.08%.
Limit of liothyronine sodium
Mobile phase,andChromatographic systemProceedasdirectedintheAssay.
Standard solutionPrepareasdirectedforStandard preparation intheAssay.
Test solutionProceedasdirectedfortheAssay preparation.
ProcedureProceedasdirectedintheAssay.Calculatethequantity,ing,ofliothyronine
sodium(C 15H11I3NNaO4)inthesampletakenbytheformula:
(672.96/650.98)(10C)(r /r )
U
inwhich672.96and650.98arethemolecularweightsofliothyroninesodiumandliothyronine,
respectively;Cistheconcentration,ingpermL,ofUSP Liothyronine RSintheStandard
preparation; andr andr aretheliothyroninepeakresponsesobtainedfromthe Test solutionand
theStandard solution, respectively:notmorethan2.0%ofliothyronineisfound.
U
Assay
Mobile phasePrepareadegassedandfilteredmixtureofwaterandacetonitrile(60:40)that
contains0.5mLofphosphoricacidineach1000mL.Makeadjustmentsifnecessary(see System
Suitability underChromatography
621 ).
inwhich798.85and776.87arethemolecularweightsoflevothyroxinesodiumandlevothyroxine,
respectively;Cistheconcentration,ingpermL,ofUSP Levothyroxine RSintheStandard
preparation; andr andr arethelevothyroxinepeakresponsesobtainedfromthe Assay
preparation andtheStandard preparation, respectively.
U