L-Proline CAS 147-85-3 (H-Pro-OH) Assy 98.5~ 101.0%

L-Proline (H-Pro-OH) (CAS: 147-85-3) AJI 97
Lepidium sativum: Confer spectrum ultrarubrum effusio exempli cum illa regulae per modum discus bromide potassium.
Specifica gyratio [α]20/D: Arida Sample, C=4, H2O
Status Solutionis (Transmittance): 1.0g in 10ml H2O, spectrophotometri, 430nm, 10mm cellulae crassitudinis.
Chloride (Cl): 0.7g, A-1, ref: 0.40ml of 0.01mol/L HCl
Aconitum (NH4): B-1
Sulfate (SO4): 1.2g, (1), ref: 0.50ml ex 0.005mol/L H2SO4
Ferrum (Fe): 1.5g, ref: 1.5ml de Iron Std.(0.01mg/ml)
Metalla gravia (Pb): 2.0g, (1), ref: 2.0ml of Pb Std.(0.01mg/ml)
Arsenicum (As2O3): 2.0g, (1), ref: 2.0ml de As2O3 Std.
Alia Amino Acides: Test Sample: 30μg, B-6-a
Damnum in remittit: ad 105℃ pro 3 horis.
Intenta: Specimen siccatum, 120mg, (1), 3ml acidi formici, 50ml acidi glacialis acetici, 0.1mol/L HCLO4 1ml=11.513mg C5H9NO2
PH Test: 1.0g in 10ml de H2O

L-Proline (H-Pro-OH) (CAS: 147-85-3) USP35 Modus Test
DEFINITIO
Proline continet NLT 98.5% et NMT 101.5% L-Proline (C5H9NO2), in fundamento siccato computatum.
IDENTIFICATIO
A. INFRARED HAUSTUS <197K>
TEMPTATIO
MODO PROCEDENDI
Sample: 110 mg Proline
Blank: Misce 3 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: Solve Sample in 3 mL acidi formici et 50mL acidi glacialis.Titrate apud Titrant.Blank determinationem praestare.
Calculare recipis Proline (C5H9NO2) in Sample desumptum:
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 = factor equivalency, 115.1 mg/mEq
W = Sample pondus (medicamentum)
Acceptatio criteria: 98.5%~ 101.5% in fundamento exsiccato
IMPURITIES
RESIDUEON DE IGNITIONE <281>: NMT 0.4%
CHLORIDE ET SULFATE, CHLORIDE <221>
Solutio mensurae: 0.50mL de acido hydrochlorico N 0.020
Sample: 0.73g of Proline
Acceptatio criteria: NMT 0.05%
CHLORIDE ET SULFATE, Sulfate <221>
Solutio Standard: 0.10mL ex 0.020 Acidi sulphurici N
Sample: 0.33g of Proline
Acceptatio criteria: NMT 0.03%
FERRUM <241>: NMT 30ppm
GRAVALIS METALS, Methodus I <231>: NMT 15ppm .
COGNATUS COMPONS
Solutio idonea ratio: 0.4mg/mL utriusque USP L-Proline RS et USP L-Threoninus RS in 0.1 N acido hydrochlorico
Solutio mensurae: 0.05mg/mL de USP L-Proline RS in 0.1 N acido hydrochlorico.[NOTA-Haec solutio retrahitur aequipollens 0.5% illius solutionis Samplei.]
Sample solutio: 10mg/mL Prolinei in 0.1 N acido hydrochlorico
Systema chromatographicum
(Vide Chromatographia <621>, Thin-Layer Chromatographia.
Modus: TLC
Adsorbent: 0.25-mm iacuit chromatographico silicae gel mixtionis
Applicationem voluminis: 5μL
Solvendo ratio explicandi: Butyl alcohol, acidum glaciale aceticum, et aqua (3:1:1)
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.
Post laminam aer exsiccans, imbre cum Spray gerente, et calor 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.
Singulae immunditiae: NMT 0.5%
Totalis immunditiae: NMT 2.0%
IN SPECIE TESTS
ROTATIO OPTICALIS, Rotatio Imprimis <781S>
Sample solutio: 40 mg/mL in aqua
Criteria acceptationis: -84.3° ad -86.3°
LOSSON EXsiccatio <731>: sicca specimen in 105℃ pro 3 h: amittit NMT 0.4% sui ponderis.
ADDITICIUS REQUISITIS
PACKAGING and storage: Conserva in vasis bene clausis.
USP Reference STANDARDS <XI>
USP L-Proline RS
USP L-Threonine RS