Tranexamic Acid CAS 1197-18-8 Assay 99.0~101.0% (Titration)

Tranexamic Acid
C8H15NO2 157.2
trans-4-(Aminomethyl) cyclohexanecarboxylic acid;
Cyclohexanecarboxylic acid, 4-(aminomethyl)-, trans [1197-18-8].
DEFINITION
Tranexamic Acid ine NLT 99.0% uye NMT 101.0% yeC8H15NO2, yakaverengerwa payakaomeswa.
KUZIVA
• Infrared Absorption <197K>
ASSAY
• Maitiro
Sample solution: 140 mg yeTranexamic Acid mu20 mL yeglacial acetic acid
Titrimetric system
(Ona Titrimetry <541>.)
Mode: Direct titration
Titrant: 0.1 N perchloric acid VS
Endpoint kuona: Potentiometric
Analysis
Muenzaniso: Sample solution
Titrate ne 0.1 N perchloric acid VS, inotarisa kuguma kwe potentiometrically.Ita titration isina chinhu.
Imwe mL ye0.1 N perchloric acid yakaenzana ne15.72 mg yeC8H15NO2.
Maitiro ekugamuchira: 99.0% -101.0% pane yakaomeswa hwaro
KUSIRIRA
Inorganic Impurities
• Residue paIgnition <281>: NMT 0.1%;1-g muenzaniso inoshandiswa
• Heavy Metals, Method II <231>: NMT 10 ppm
• Chloride neSulfate, Chloride <221>: Chikamu che0.51-g hachiratidzi chloride kupfuura inoenderana ne0.1 mL ye0.020 N hydrochloric acid (0.014%).
Organic Kusachena
• Maitiro
Nharembozha: Dissolve 11.0 g ye anhydrous monobasic sodium phosphate mu 500 mL yemvura, uye wedzera 5 mL ye triethylamine, inoteverwa ne 1.4 g ye sodium lauryl sulfate.Gadzirisa ne diluted phosphoric acid (10% w/w) kusvika pH ye2.5, uye dilue nemvura kusvika ku600 mL.Sanganisa mhinduro iyi ne 400 mL ye methanol.
Kukodzera kweSystem solution: 0.2 mg/mL yeUSP Tranexamic Acid RS uye 0.002 mg/mL yeUSP Tranexamic Acid Related Compound C RS mumvura
Mushonga wakajairika: 50 µg/mL yeUSP Tranexamic Acid RS mumvura
Sample solution: 10 mg/mL yeTranexamic Acid mumvura
Chromatographic system
(Ona Chromatography <621>, System Suitability.)
Modhi: LC
Detector: UV 220 nm
Column: 4.6-mm × 25-cm;5-µm kurongedza L1
Kuyerera: 1 mL / min
Jekiseni saizi: 20 µL
Nguva yekumhanya: 3 nguva yekuchengeta tranexamic acid
Kukodzera kwehurongwa
Sample: System kukodzera mhinduro
Kukodzera zvinodiwa
Resolution: NLT 2.0 pakati peTranexamic Acid uye 0.002 mg/mL ye tranexamic acid ine hukama C
Analysis
Samples: Yakajairwa mhinduro uye Sample mhinduro
Verenga chikamu chekusachena kwega kwega muchikamu cheTranexamic Acid yakatorwa:
Mhedzisiro = (rU/rS) × (CS/CU) × (0.1F)
rU = peak mhinduro yekusachena yega yega kubva kuSample solution
rS = peak mhinduro yetranexamic acid kubva kune Standard solution
CS = kuunganidzwa kweUSP Tranexamic Acid RS muiyo Standard solution (µg/mL)
CU = kusangana kweTranexamic Acid muSample solution (mg/mL)
F = hama yekupindura chinhu (ona Kusachena Tafura 1)
Maitiro ekugamuchira
Kusachena kwemunhu: Ona Kusachena Tafura 1.
Yese tsvina: NMT 0.2%
[Cherechedza-Rega chero nhamba yepamusoro isingasviki 0.025%.]
Kusachena Tafura 1
Zita Nechekuchengeta Nguva Yehukama Mhinduro Factor Yekugamuchirwa, NMT (%)
Tranexamic acid ine chekuita nemubatanidzwa Aa 2.1 1 0.1
Tranexamic acid ine hukama Bb 1.5 1.2 0.2
Tranexamic acid ine chekuita nemubatanidzwa Cc 1.1 0.005 0.1
Tranexamic Acid 1.0 1.0 -
Tranexamic acid ine chekuita nemubatanidzwa Dd 1.3 0.006 0.1
a trans,trans-4,4¢-(Iminodimethylene)di(cyclohexanecarboxylic)asidhi.
b cis-4-(Aminomethyl) cyclohexanecarboxylic acid.
c (RS) -4- (Aminomethyl) cyclohex-1-enecarbocylic acid.
d 4-Aminomethyl benzoic acid.
ZVIYEDZO ZVAKANAKA
• Kurasikirwa paKuomesa <731>: Dry 1.00 g pa 105 pasi pevacuum kwe2 h.Inorasikirwa neNMT 0.5% yehuremu hwayo.
ZVIMWE ZVINODIWA
• Kurongedza uye Kuchengeta: Chengetedza mumidziyo yakaoma, uye chengeta pane tembiricha isingadariki makumi matatu.
• USP Reference Standards <11>
USP Tranexamic Acid RS Dzvanya kuti uone Chimiro
USP Tranexamic Acid Inoenderana Necompound C RS
(RS) -4- (Aminomethyl) cyclohex-1-enecarbocylic acid.
C8H13NO2 155