Acidum tranexicum CAS 1197-18-8

Acidum tranexicum
C8H15NO2 157.2
trans-4-(Aminomethyl) acidum cyclohexanecarboxylicum;
acid, 4-(aminomethyl)-, trans [1197-18-8].
DEFINITIO
Acidum tranexicum NLT 99.0% et NMT 101.0% C8H15NO2 continet, fundamento siccato computatum.
IDENTIFICATIO
• Effusio infrared <197K>
TEMPTATIO
• De modo procedendi
Sample solutio: 140 mg Acidi traneximi in 20 mL acidi glacialis
Systema titrimetricum
(Vide Titrimetrium <541>.)
Modus: Direct titration
Titrant: 0.1 N acidum perchloricum VS
Endpoint deprehensio: Potentiometric
Analysis
Sample: Sample solution
Titrate cum 0.1 N acido perchlorico VS, terminum potentiometrice determinans.Exsequi blank titration.
Quodlibet mL aci perchlorici 0.1 N valet cum 15.72 mg C8H15NO2.
Acceptatio criteria: 99.0%-101.0% in fundamento exsiccato
IMPURITIES
Inorganic immunditias
• Residuum in Ignitione <281>: NMT 0.1%;I-g sample adhibetur
• Metalla gravia, Methodus II <231>: NMT 10 ppm .
• Chloride et Sulfate, Chloride <221>: Pars 0.51-g non magis chloridi ostendit quam respondet 0.1 mL acidi hydrochlorici 0.020 N (0.014%).
Impurities organica
• De modo procedendi
Mobilis Phase: Solve 11.0 g phosphate anhydroi monobasici sodii 500 mL aquae, et triethylamine 5 mL adde, sequitur 1.4 g sulphatis sodii lauritici.Acidum phosphoricum dilutum compone (10% w/w) ad pH 2.5, et cum aqua dilutum ad 600 mL.Hanc solutionem misce cum 400 mL methanoli.
Solutio aptabilitas systematis: 0.2 mg/mL USP Acidum tranexamic RS et 0.02 mg/mL USP Acidum trannexamicum Compositum C RS in aqua comparatum.
Solutio mensurae: 50 µg/mL of USP Acidum Tranexamicum RS in aqua
Sample solutio: 10 mg/mL de acido tranexico in aqua
Systema chromatographicum
(Vide Chromatographiam <621>, Ratio idoneitatis.)
Modus: LC
Detector: UV 220 nm
Columna: 4.6-mm × 25-cm;5-µm stipare L1
Fluunt rate: 1 mL/min
Iniectio amplitudo: 20 µL
Curre tempus: 3 tempora retentionis tempus acidum tranexicum
Ratio convenientia
Sample: Ratio idoneitatis solutionis
Convenientia requisita
Resolutio: NLT 2.0 inter Acidum tranexicum et 0.002 mg/mL acidi trannexamici compositi C affinis.
Analysis
Exempla: Standard solution et Sample solutionem
Recipis impuritatem in portione Tranexamici acido sumpto;
Proventus = (rU/rS) (CS/CU) (0.1F)
rU = cacumen responsionis pro qualibet immunditia ex solutione Sample
rS = apicem responsio ad tranexamicum acidum ex solutione Latin
CS = coniunctio USP Tranexamic Acidum RS in solutione Standard (μg/mL)
CU = intentio Acidi tranexici in Sample solutione (mg/mL)
F = responsio relativa factor (vide Tabula immunditia 1)
Criteria acceptatio
Individua Impudicitia: Vide Mensam Impuritas 1 .
Totalis immunditiae: NMT 0.2%
[Nota-Contemnere aliquem apicem minus quam 0.025%.]
De immunitate Tabula 1
Nomen relativum Retentionis Time Relativi Response Factor Acceptationis Criteria, NMT (%)
Acidum traneximicum compositum affinis Aa 2.1 1 0.1
Acidum tranexamic cognatum compositum Bb 1.5 1.2 0.2
Acidum traneximicum compositum affinis Cc 1.1 0.005 0.1
Acidum tranexicum 1.0 1.0 —
Acidum traneximicum affinis compositi Dd 1.3 0.006 0.1
a trans, trans 4,4¢.
b cis-4-(Aminomethyl) acidum cyclohexanecarboxylicum.
c (RS) -4-(Aminomethyl) acidum cyclohex-1-enecarbocylicum.
d 4-Aminomethyl acidum benzoicum.
IN SPECIE TESTS
• Amissio in Remittit <731>: Sicca 1.00 g ad 105 sub vacuo pro 2 h.0.5% NMT pondus amittit.
ADDITICIUS REQUISITIS
• Packaging and storage : Serva in arctis vasis , et repone temperiem non excedentem 30 .
• USP Signa Reference <11>
USP Tranexamic Acidum RS Click to View Structure
USP Tranexamic Acidum Related Compone C RS
(RS) -4-(Aminomethyl) acidum cyclohex-1-enecarbocylicum.
C8H13NO2 155