N-Acetyl-L-Tyrosine CAS 537-55-3 (Ac-Tyr-OH; NALT) Assay 99.0 ~ 101.0 Hoobkas

N-Acetyl-L-Tyrosine (Ac-Tyr-OH; NALT) (CAS: 537-55-3) AJI97 Test Method
N-Acetyl-L-Tyrosine, thaum qhuav, muaj tsis tsawg tshaj li 99.0 feem pua ​​thiab tsis ntau tshaj 101.0 feem pua ​​ntawm N-Acetyl-L-Tyrosine (C11H13NO4).
Nqe lus piav qhia: Dawb crystals los yog crystalline hmoov, muaj zog acid saj
Dawb soluble nyob rau hauv dej.
Solubility (H2O, g / 100g): 17.5 (20 ℃), 72.4 (40 ℃), 158 (60 ℃)
Kev txheeb xyuas: Sib piv cov infrared absorption spectrum ntawm cov qauv nrog cov qauv ntawm cov txheej txheem potassium bromide disc.
Kev sib hloov tshwj xeeb [α]20 / D: Cov qauv qhuav, C = 4, H2O
State of Solution (Transmittance): 0.5g hauv 10ml ntawm H2O, spectrophotometer, 430nm, 10mm cell thickness.
Chloride (Cl): 0.7g, A-1, ref: 0.40ml ntawm 0.01mol / L HCl
Ammonium (NH4): B-1
Sulfate (SO4): 1.2g, (1), ref: 0.50ml ntawm 0.005mol / L H2SO4
Hlau (Fe): 0.5g, ref: 1.5ml ntawm Hlau Std.(0.01 mg/ml)
Heavy Metals (Pb): 2.0g, (3), ref: 2.0ml ntawm Pb Std.(0.01 mg/ml)
Arsenic (As2O3): 1.0g, (1), ref: 2.0ml ntawm As2O3 Std.
Poob rau ziab: ntawm 105 ℃ rau 3 teev
Residue ntawm Ignition (Sulfated): AJI Test 13
Assay: Dried sample, 300mg, (1), 40ml H2O, (2), 0.1mol/L NaOH, 1ml = 22.323mg C11H13NO4
Tyrosine: Ua kua chromatography.Kev khiav hauj lwm mob: Ntes: UV nqus photometer (214nm);Kem: ODS, 4.6mm x 150mm;Kem Kub: Chav kub.Tus nqi ntws: 1ml / min;Mobile theem: 0.04mol / L tov ntawm monopotassium phosphate (pH 4.35): Methanol (193:3)
pH: 1.25g hauv 50ml H2O
Pom zoo cia txwv thiab mob: khaws cia ntim ntim ntawm qhov ntsuas kub (2 xyoos).

N-Acetyl-L-Tyrosine (Ac-Tyr-OH; NALT) (CAS: 537-55-3) USP35 Test Method
DEFINITION
N-Acetyltyrosine muaj NLT 98.5% thiab NMT 101.0% ntawm C11H13NO4, raws li N-Acetyl-L-Tyrosine, xam ntawm lub hauv paus qhuav.
IDENTIFICATION
A. INFRARED ABSORPTION <197K>
B. OPTICAL ROTATION, Kev sib hloov tshwj xeeb <781S>
Sample kua: 10 mg/mL
Kev lees txais: NLT + 46.0 ° thiab NMT + 49.0 °, txiav txim siab ntawm 20 °
C. Tus nqi RF ntawm qhov chaw tseem ceeb ntawm cov qauv kev daws teeb meem hauv kev sim rau Organic Impurities sib raug rau qhov kev daws teeb meem 1.
QHIA
txheej txheem
Piv txwv li: Dissolve txog 180 mg ntawm N-Acetyltyrosine, hnyav, hauv 50 mL ntawm cov dej tsis muaj carbon dioxide.
Titrimetric system
(Saib Titrimetry <541>)
Hom: Direct titration
Titrant: 0.1N sodium hydroxide VS
Endpoint detection: Potentiometric
Sib npaug: Txhua mL ntawm 0.1 N sodium hydroxide VS yog sib npaug rau 22.32 mg ntawm C11H13NO4.
IMPURITIES
Inorganic impurities
RESIDUEON IGNITION <281>: NMT 0.1%
CHLORIDE THIAB SULFATE, Chloride <221> NMT 200 ppm.Ib feem ntawm 0.7-g qhia tias tsis muaj chloride ntau dua li 0.40 mL ntawm 0.01 N hydrochloric acid.
CHLORIDE THIAB SULFATE, Sulfate <221> NMT 200 ppm.Ib feem 1.2-g qhia tias tsis muaj sulfate ntau dua li 0.25 mL ntawm 0.020 N sulfuric acid.
Hlau <241>: NMT 20ppm
HEAVY METALS, Method I <231>: NMT 10ppm
Organic impurities
txheej txheem
Adsorbent: 0.25-mm txheej ntawm chromatographic silica gel sib tov
Standard Tshuag tov 1: 8 mg / mL ntawm USP N-Acetyl-L-tyrosine RS nyob rau hauv ib tug sib tov ntawm dej, glacial acetic acid, thiab cawv (3: 3: 94)
Standard tov 1: Dilute Standard Tshuag tov tov 1 nrog cawv kom tau ib tug paub txog concentration ntawm txog 0.4 mg/mL
Standard tov 2: 0.8 mg / mL ntawm USP L-Tyrosine RS yaj nyob rau hauv ib tug sib tov ntawm glacial acetic acid thiab dej (1: 1), thiab diluted nrog cawv.
Piv txwv li: Hloov 0.8 g ntawm N-Acetyltyrosine mus rau 10-mL volumetric hwj, yaj nyob rau hauv 6 mL ntawm ib tug sib tov ntawm glacial acetic acid thiab dej (1: 1), thiab dilute nrog cawv rau ntim.
Daim ntawv thov ntim: 5 µL
Kev tsim cov kuab tshuaj: Kev sib xyaw ntawm ammonia thiab 2-propanol (3: 7)
Txau reagent: Dissolve 0.2 g ntawm ninhydrin hauv 100 mL ntawm kev sib xyaw ntawm butanol thiab 2 N acetic acid (95: 5).
Qhov system haum
Kev xav tau kev tsim nyog: Lub chromatogram ntawm qhov kev daws teeb meem tsim nyog nthuav tawm ob qhov sib cais kom meej.
Kev tsom xam: Ua raws li qhia rau Chromatography <621> Thin-Layer Chromatography.Tom qab cua tshuab ziab lub phaj, rov ua txoj kev txhim kho.Tom qab cua qhuav zaum ob, tshuaj tsuag nrog tshuaj tsuag reagent, thiab cua sov ntawm 100 ° thiab 105 ° rau li 15 feeb.
Kev lees txais cov qauv: Txhua qhov chaw thib ob ntawm cov qauv kev daws teeb meem tsis loj dua lossis khaus ntau dua li qhov chaw tseem ceeb ntawm Cov Txheej Txheem Kev daws teeb meem 1, tshwj tsis yog rau qhov chaw sib xws rau tyrosine, uas tsis loj dua lossis khaus ntau dua li qhov chaw tseem ceeb ntawm Standard tov 2.
Tus kheej impurities: NMT 0.5%
Kev txwv ntawm tyrosine: NMT 1.0%
TSEEM CEEB
LOSSON DRYING <731>: Qhuav ib qho qauv ntawm 105 ℃ rau 3 h: nws poob NMT 0.1% ntawm nws qhov hnyav.
TSEEM CEEB
PACKAGING THIAB STORAGE: Khaws rau hauv cov thawv kaw kom zoo, thiab khaws cia ntawm chav tsev kub.
USP REFERENCE STANDARDS <11>
USP N-Acetyl-L-tyrosine RS
USP L-Tyrosine RS