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

Tranexamic Acid
C8H15NO2 157.2
trans-4-(Aminomethyl) cyclohexanecarboxylic acid;
Cyclhexanecarboxylic acid, 4-(aminomethyl)-, trans [1197-18-8].
DEFINITION
Tranexamic Acid muaj NLT 99.0% thiab NMT 101.0% ntawm C8H15NO2, suav ntawm lub hauv paus qhuav.
IDENTIFICATION
• Infrared Absorption <197K>
QHIA
• Cov txheej txheem
Piv txwv li: 140 mg ntawm Tranexamic Acid hauv 20 mL ntawm glacial acetic acid
Titrimetric system
(Saib Titrimetry <541>.)
Hom: Direct titration
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Potentiometric
Kev tsom xam
Qauv: qauv tov
Titrate nrog 0.1 N perchloric acid VS, txiav txim siab qhov kawg ntawm potentiometrically.Ua ib qho titration dawb paug.
Txhua mL ntawm 0.1 N perchloric acid yog sib npaug rau 15.72 mg ntawm C8H15NO2.
Kev lees txais: 99.0% -101.0% ntawm lub hauv paus qhuav
IMPURITIES
Inorganic impurities
• Residue ntawm Ignition <281>: NMT 0.1%;1-g qauv yog siv
• Heavy Metals, Method II <231>: NMT 10 ppm
• Chloride thiab Sulfate, Chloride <221>: Ib feem ntawm 0.51-g qhia tias tsis muaj chloride ntau dua li 0.1 mL ntawm 0.020 N hydrochloric acid (0.014%).
Organic impurities
• Cov txheej txheem
Txawb theem: Dissolve 11.0 g ntawm anhydrous monobasic sodium phosphate hauv 500 mL dej, thiab ntxiv 5 mL ntawm triethylamine, tom qab ntawd 1.4 g ntawm sodium lauryl sulfate.Kho nrog diluted phosphoric acid (10% w / w) rau pH ntawm 2.5, thiab dilute nrog dej mus rau 600 mL.Sib tov cov tshuaj no nrog 400 mL ntawm methanol.
Kev daws teeb meem tsim nyog: 0.2 mg / mL ntawm USP Tranexamic Acid RS thiab 0.002 mg / mL ntawm USP Tranexamic Acid Related Compound C RS hauv dej
Kev daws teeb meem: 50 µg / mL ntawm USP Tranexamic Acid RS hauv dej
Piv txwv li: 10 mg / mL ntawm Tranexamic Acid hauv dej
Chromatographic system
(Saib Chromatography <621>, System Suitability.)
Qauv: LC
Detector: UV 220 nm
Kem: 4.6-mm × 25-cm;5-µm ntim L1
Tus nqi ntws: 1 mL / min
Kev txhaj tshuaj loj: 20 µL
Lub sijhawm ua haujlwm: 3 zaug lub sijhawm khaws cia ntawm tranexamic acid
Qhov system haum
Qauv: Kev daws teeb meem tsim nyog
Suitability xav tau
Kev daws teeb meem: NLT 2.0 nruab nrab ntawm Tranexamic Acid thiab 0.002 mg / mL ntawm tranexamic acid ntsig txog C
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam cov feem pua ​​​​ntawm txhua tus neeg impurity nyob rau hauv ib feem ntawm Tranexamic Acid noj:
Result = (rU/rS) × (CS/CU) × (0.1F)
rU = ncov teb rau txhua impurity los ntawm cov qauv tov
rS = ncov teb rau tranexamic acid los ntawm Standard tov
CS = concentration ntawm USP Tranexamic Acid RS nyob rau hauv Standard tov (µg/mL)
CU = concentration ntawm Tranexamic Acid nyob rau hauv cov qauv tov (mg / mL)
F = tus txheeb ze teb qhov tseem ceeb (saib Impurity Table 1)
Kev lees txais
Ib tug neeg impurities: Saib Impurity Table 1.
Tag nrho impurities: NMT 0.2%
[Ceeb Toom-Tsis lees paub qhov siab tshaj plaws tsawg dua 0.025%.]
Impurity Table 1
Lub Sijhawm Relative Retention Time Relative Response Factor Acceptance Criteria, NMT (%)
Tranexamic acid muaj feem xyuam nrog Aa 2.1 1 0.1
Tranexamic acid ntsig txog Bb 1.5 1.2 0.2
Tranexamic acid muaj feem xyuam nrog Cc 1.1 0.005 0.1
Tranexamic Acid 1.0 1.0 -
Tranexamic acid muaj feem xyuam nrog Dd 1.3 0.006 0.1
a trans,trans-4,4¢-(Iminodimethylene)di(cyclohexanecarboxylic)acid.
b cis-4-(Aminomethyl) cyclohexanecarboxylic acid.
c (RS)-4-(Aminomethyl) cyclohex-1-enecarbocylic acid.
d 4-Aminomethyl benzoic acid.
TSEEM CEEB
• Loss on Drying <731>: Qhuav 1.00 g ntawm 105 nyob rau hauv lub tshuab nqus tsev rau 2 h.Nws poob NMT 0.5% ntawm nws qhov hnyav.
TSEEM CEEB
• Ntim thiab Cia: Khaws rau hauv cov thawv nruj, thiab khaws cia ntawm qhov kub tsis tshaj 30.
• USP Reference Standards <11>
USP Tranexamic Acid RS Nyem rau Saib Cov Qauv
USP Tranexamic Acid Related Compound C RS
(RS)-4-(Aminomethyl)cyclohex-1-enecarbocylic acid.
Txa8H13NO2 155