L-(-)-Tyrosine CAS 60-18-4 (H-Tyr-OH) Assy 98.5~ 101.5% Factory High Quality

L-(-)-Tyrosine (H-Tyr-OH) (CAS: 60-18-4) AJI 97 Methodus test.
Lepidium sativum: Confer spectrum ultrarubrum effusio exempli cum illa regulae per modum discus bromide potassium.
Specific rotationis [α]20/D: Aridae Sample, C=5, 1mol/L HCl
Status Solutionis (Transmittance): 0.5g in 10ml 1mol/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): 1.5g, (2), ref: 1.5ml of Iron Std.(0.01mg/ml)
Metalla gravia (Pb): 2.0g, (2), ref: 2.0ml of Pb Std.(0.01mg/ml)
Arsenicum (As2O3): 2.0g, (2), ref: 2.0ml de As2O3 Std.
Alia Amino Acides: ammoniae dilutae R2 Test Sample: 50μg, F-6-a, imperium: L-Tyr 0.25μg
Damnum in remittit: ad 105℃ pro 3 horis.
Residere in Ignitione (Sulfated): AJI Test 13
Intenta: specimen exsiccatum, 180mg, (1), 6ml acidum formic, 50ml acidi glacialis acetici, 0.1mol/L HCLO4 1ml=18.119mg C9H11NO3
pH Test: 0.02g in 100ml solutione aquea saturata

L-(-)-Tyrosine (H-Tyr-OH) (CAS: 60-18-4) USP35 Test Methodus
DEFINITIO
Tyrosina continet NLT 98.5% et NMT 101.5% L-Tyrosine (C9H11NO3), in fundamento siccato computatum.
IDENTIFICATIO
A. INFRARED HAUSTUS <197K>
TEMPTATIO
MODO PROCEDENDI
Sample: 180 mg Tyrosinae
Blank: Misce 6 mL acidi formici et 50 mL acidi glacialis.
Systema titrimetricum
(Vide Titrimetrium<541>)
Modus: Direct titration
Titrant: 0.1 N acidum perchloricum VS
Endpoint deprehensio: Potentiometric
Analysis: Exemplum solve in 6 mL acidi formici et 50mL acidi glacialis ac titrati cum titranti.Blank determinationem praestare.
Recipis tyrosinam (C9H11NO3) in Sample sumptam:
Exitus = {[(VS-VB) x N x F]/W} x100
VS = volumen de Titrant consumptum in Sample (mL)
VB = volumen Titrant consumtum a Blank (mL)
N = re normalitatis de Titrant (mEq/mL)
F= aequivalentia factor, 181.2 mg/mEq
W = Sample pondus (medicamentum)
Acceptatio criteria: 98.5%~ 101.5% in fundamento exsiccato
IMPURITIES
RESIDUEON IGNIS <281>: NMT 0.4%
CHLORIDE ET SULFATE, CHLORIDE <221>
Solutio Standard: 0.20mL de acido hydrochlorico N 0.020
Sample: 0.35 g Tyrosine.[Nota Si opus est, calefactione dissolve Samplum prope bullientem et addendo 1 mL acidi nitrici.
Acceptatio criteria: NMT 0.04%
CHLORIDE ET SULFATE, Sulfate <221>
Solutio Standard: 0.50mL ex acido sulphurico N 0.020
Sample: 1.2 g Tyrosine.[Nota Si opus est, Sample dissolve addito 6 mL acidi hydrochlorici diluti.]
Acceptatio criteria: NMT 0.04%
FERRUM <241>: NMT 30ppm [NOTA-Si opus est, utere 2 mL acidi hydrochlorici ad Sample solvendum.]
GRAVALIS METALS, Methodus I <231>: NMT 15ppm .
COGNATUS COMPONS
Solutio ammoniaci diluta: diluta ammoniaci concentrata 16 mL cum aqua ad 100 mL.
Solutio idoneitatis systematis: Solve 10 mg USP L-tyrosini RS et 10 mg USP L-Phenylalanini RS in 1 mL solutionis ammoniae diluti et aqua diluti ad 25.0 mL.
Solutio Standard: In apto lagena solve quantitatem USP L-Tyrosinae RS in 1 mL solutionis ammoniae dilutae.Aqua diluto ad volumen solutionem obtinendam 0.05mg/mL.[NOTA-Haec solutio retrahitur aequipollens 0.5% illius solutionis Samplei.]
Sample solutio: Translatio 0.1 g Tyrosinae in laginem voluminis 10-mL, adde solutionem ammoniacam dilutam sufficientem ad solvendum, et aqua ad volumen diluendum.
Systema chromatographicum (Vide Chromatographia <621>, chromatographia Thin-Layer.)
Modus: TLC
Adsorbent: 0.25-mm iacuit chromatographico silicae gel mixtionis
Applicationem voluminis: 5μL
Solvendo ratio explicandi: Isopropyl alcohol et ammonium hydroxidum (7:3)
Imbre reagens: 2 mg/mL ninhydrin in mixtione alcoholi butyl et 2N acidi acetici (95:5).
Ratio convenientia
Opportunitas requisita: solutio chromatogramma Systematis convenientia ostendit duas maculas distincte separatas.
Analysis
Exempla: Ratio idoneitatis solutio, solutionis Latin, et solutionis Sample.
bractea inter 100° et 105° excoquatur donec ammoniaca penitus evanescat.Imbre cum Spray gerente, et calore inter 100° et 105° pro 15 min.Discute laminam sub lumine albo.
Criteria acceptationis: Quaelibet macula secundaria solutionis Sample non maior vel intensior est quam macula principalis solutionis Standardi.
Singula immunditia: NMT 0.5%
Totalis immunditiae: NMT 2.0%
IN SPECIE TESTS
ROTATIO OPTICALIS, Rotatio Imprimis <781S>
Sample solutio: 50 mg/mL in 1 N acido hydrochlorico
Acceptatio criteria: -9.8° ad -11.2°
LOSSON DE ARIFICATIONE <731>: Exemplum sicca in 105℃ pro 3 h: amittit NMT 0.3% sui ponderis.
ADDITICIUS REQUISITIS
PACKAGING and storage: Conserva in vasis bene clausis.
USP Reference STANDARDS <XI>
USP L-Phenylalanine RS
USP L-Tyrosine RS