L-Tryptophan CAS 73-22-3 (H-Trp-OH) Assy 98.5~ 101.5%

L-Tryptophan (H-Trp-OH) (CAS: 73-22-3) AJI 97 Modus Test
Lepidium sativum: Confer spectrum ultrarubrum effusio exempli cum illa regulae per modum discus bromide potassium.
Specifica gyratio [α]20/D: arida Sample, C=1, H2O solve calefaciendo.
Status Solutionis (Transmittance): 0.5g in 20ml 2 mol/L HCl, spectrophotometri, 430nm, 10mm cellulae crassitudinis.
Chloride (Cl): 0.7g, A-1, ref: 0.40ml of 0.01mol/L HCl
Aconitum (NH4): B-2
Sulfate (SO4): 1.2g, (1), ref: 0.50ml ex 0.005mol/L H2SO4
Ferrum (Fe): 0.75g, (2), ref: 1.5ml Iron Std.(0.01mg/ml)
Metalla gravia (Pb): 2.0g, (4), ref: 2.0ml of Pb Std.(0.01mg/ml)
Arsenicum (As2O3): 2.0g, (1), ref: 2.0ml de As2O3 Std.
Alia Amino Acides: H2O, solve calefaciendo (40℃) Test Sample: 50μg, A-6-a, imperium: L-Trp 0.25μg
Damnum in remittit: ad 105℃ pro 3 horis.
Residere in Ignitione (Sulfated): AJI Test 13
Intenta: Specimen siccatum, 200mg, (1), 3ml acidi formici, 50ml acidi glacialis acetici, 0.1mol/L HCLO4 1ml=20.423mg C11H12N2O2
PH Test: 1.0g in 100ml de H2O

L-Tryptophan (H-Trp-OH) (CAS: 73-22-3) USP35 Test methodus
DEFINITIO
Tryptophan continet NLT 98.5% et NMT 101,5% C11H12N2O2, ut L-Tryptophan, in fundamento siccato computatum.
IDENTIFICATIO
A. INFRARED HAUSTUS <197K>
TEMPTATIO
MODO PROCEDENDI
Sample solutio: Locus 200 mg Tryptophanorum in vase 125-mL.Dissolve in mixtura 3 mL acidi formici et 50 mL acidi glacialis.
Analysis: Titrate cum acido perchlorico 0.1 N VS, terminum potentiometrice determinans.Praestare blank determinationem, et correctionem quamlibet necessariam facere (cf. Titrimetria <541>).Quodlibet mL acidi perchlorici 0.1 N valet cum 20.42 mg C11H12N2O2.
Acceptatio criteria: 98.5%~ 101.5% in fundamento exsiccato
IMPURITIES
Inorganic immunditias
RESIDUEON IGNIS <281>: NMT 0.1%
CHLORIDE ET SULFATE, CHLORIDES <221>: Pars 0.73-g non magis chloridi ostendit quam 0,50 mL 0.020 Acidi hydrochlorici N (0.05%).[Nota Leniter calefacit specimen praeparationis ad dissolvendum, si opus est.]
CHLORIDE ET SULFATE, Sulfate <221>: Pars 0.33-g non plus ostendit sulphate quam respondet 0.10 mL 0.020 Acidi sulphurici N (0.03%).[Nota Leniter calefacit specimen praeparationis ad solvendum, si necesse est.
FERRUM <241>: NMT 30ppm
METALS GRAVALIS, Methodus II <231>: NMT 15ppm .
Impurities organica
MODO PROCEDENDI 1
Solutio A: Acidum trifluoroaceticum in aqua (1 mL/L)
Solutio B: Acidum trifluoroaceticum in acetonitrili et aquae solutione (80:20) (1 mL/L solutio acidi trifluoroacetici)
Vexillum solutionis: 1.0 mg/L uterque USP Tryptophan Related Compone A RS et USP Tryptophan Related Compone B RS in aqua
Sample solutio: 10.0 mg/mL tryptophan in aqua
Systema idoneitatis solutionis: 1.0 mg/L of USP Tryptophan Composita B RS in aqua
Mobile tempus: Vide infra mensam gradientem.

Systema chromatographicum (Vide Chromatographia <621>, Systema Suitability).
Modus: LC
Detector: UV 220 nm
Columna: 4.6-mm × 25-cm;5-µm stipare L1
Columna temperatus: 30°
Fluunt rate: 1 mL/min
Iniectio amplitudo: 20 µL
Ratio convenientia
Sample: Ratio idoneitatis solutionis
Opportunitas postulationem
Relativum vexillum declinationis: NMT 5.0%
Analysis
Exempla: Standard solution et Sample solutionem
Calculate recipis immunditiam singularum in portione Tryptophani desumptae;
Proventus = (rU/rS) (CS/CU) 100
rU = cacumen cuiusvis immunditiae non specificatae in solutione Sample
rS = apicem area tryptophan related compositis B in solutione Latin
CS = concentratio USP Tryptophan Composita Composita B RS in solutione Vulgata (μg/mL)
CU = intentio Tryptophani in solutione Sample (μg/mL)
Criteria acceptatio
Totalis immunditias 1: NMT 0.01% totius immunditiae eluentis ante apicem tryptophan
Totalis immunditiae 2: NMT 0.03% totius immunditiae post tryptophan apicem eluentis.[NOTA-Excludere apicem pro tryptophan affinis compositi B.]
Tryptophan affinis compositi A: Si apicem pro tryptophan affinis compositi A observatur in solutione Sample, deinde experimentum procedendi 2 perficies: Terminus Tryptophan Composito A, infra.
II DE MODO PROCEDENDI: DE TRYPTOPHAN AGNATIS COMPONO FINIS A*
Solutio A: 18 mM Natri monobasici phosphas, percolata et degassata (pH 2.5), et acetonitrile (9: 1).
Solutio B: 10 mM Natri monobasici phosphatis, saccati et degassi (pH 2.5), et acetonitrili (1:1).
Solutio C: Acetonitrile in aqua (7, 3).
Vexillum solutionis: 0.1 mg/L of USP Tryptophan Related Compone A RS in aqua
Sample solutio: 10.0 mg/mL Tryptophanae in aqua
Mobile tempus: Vide infra mensam gradientem

Systema chromatographicum
(Vide Chromatographiam <621>, Ratio idoneitatis.)
Modus: LC
Detector: UV 216 nm
Columna: 3.9-mm × 15-cm;5-µm stipare L1
Columna temperatus: 30°
Fluunt rate: 1 mL/min
Iniectio amplitudo: 20 µL
Ratio convenientia
Sample: Latin solution
Opportunitas postulationem
Relativum vexillum declinationis: NMT 5.0%
Analysis
Exempla: Standard solution et Sample solutionem
Adice tryptophan related compositis recipis
A in parte Tryptophan.
Proventus = (rU/rS) (CS/CU) 100
rU = apicem areae tryptophan relatae compositae A in Sample solutione
rS = apicem area de tryptophan related compositis A in solutione Latin
CS = intentio USP Tryptophan Composita A RS in solutione Standard (µg/mL)
CU = intentio Tryptophani in solutione Sample (μg/mL)
Acceptatio criteria: NMT 10 ppm
IN SPECIE TESTS
ROTATIO OPTICALIS, Rotationis Imprimis <781S>: -29.4° ad -32.8°
Sample solutio: 10 mg/mL, in aqua.Leniter calor, si opus est, dissolvere.
PH <791>: 5.5~7.0, in solutione (1 in 100)
DE siccitate <731>: exemplum sicca apud 105° pro 3 h: amittit NMT 0.3% sui ponderis.
ADDITICIUS REQUISITIS
PACKAGING et Repono: Conserva in vasis bene clausis
USP Reference STANDARDS <XI>
USP L-Tryptophan RS
USP Tryptophan Related Compone RS
3,3′-[Ethylidenebis(1H-indole-1,3-diyl)]bis[2S)-2-aminopropanoic]acidum.C24H26N4O4 432.49
USP Tryptophan Related Compone B RS
2-acetamido-3-(1H-indol-3-yl) Acidum propanoicum.C13H14N2O3 246.3