Waikawa Tranexamic CAS 1197-18-8 Whakamātautau 99.0~101.0% (Titaration)

Waikawa Tranexamic
C8H15NO2 157.2
trans-4-(Aminomethyl) waikawa cyclohexanecarboxylic;
Te waikawa Cyclohexanecarboxylic, 4-(aminomethyl)-, trans [1197-18-8].
WHAKAMAHI
Ko te Waikawa Tranexamic kei roto i te NLT 99.0% me te NMT 101.0% o C8H15NO2, kua tatauhia i runga i te whakamaroke.
WHAKATAUTANGA
• Te Kohanga Infrared <197K>
WHAKAMAHI
• Tikanga
Tauira otinga: 140 mg o te Waikawa Tranexamic i roto i te 20 mL o te waikawa ahetiki hukapapa
Pūnaha Titrimetric
(Tirohia Titrimetry <541>.)
Aratau: Te titration tika
Titrant: 0.1 N te waikawa perchloric VS
Te kitenga ira mutunga: Potentiometric
Tātaritanga
Tauira: Tauira otinga
Whakatairitetia ki te 0.1 N te waikawa perchloric VS, te whakatau i te waahi mutunga.Whakahaerehia he titration patea.
Ko ia mL o te 0.1 N te waikawa perchloric he rite ki te 15.72 mg o C8H15NO2.
Paearu whakaae: 99.0% -101.0% i runga i te whakamaroke
NGA POKE
Nga poke parakore
• Te toenga i runga i te mura <281>: NMT 0.1%;Ka whakamahia te tauira 1-g
• Nga Koura Nui, Tikanga II <231>: NMT 10 ppm
• Chloride and Sulfate, Chloride <221>: Ko te wahanga 0.51-g e whakaatu ana kaore e nui ake te chloride ki te 0.1 mL o te 0.020 N waikawa pūhaumāota (0.014%).
Nga poke pararopi
• Tikanga
Wāhanga pūkoro: Whakarewahia te 11.0 g konutai konutai konutai konutai i roto i te 500 mL wai, ka tāpirihia te 5 mL o te triethylamine, ka whai i te 1.4 g o te konutai lauryl sulfate.Whakaritea ki te waikawa ūkuikui (10% w/w) ki te pH 2.5, ka waimeha ki te wai ki te 600 mL.Whakaranuhia tenei otinga ki te 400 mL o te mewaro.
Te otinga pai o te punaha: 0.2 mg/mL o te USP Tranexamic Acid RS me te 0.002 mg/mL o te USP Tranexamic Acid Related Compound C RS i te wai
Te otinga paerewa: 50 µg/mL o USP Tranexamic Acid RS i roto i te wai
Tauira otinga: 10 mg/mL o te Waikawa Tranexamic i te wai
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Whakaritenga Pūnaha.)
Aratau: LC
Kaitirotiro: UV 220 nm
Tīwae: 4.6-mm × 25-cm;5-µm tākai L1
Rere rere: 1 mL/min
Rahi werohanga: 20 µL
Wā oma: 3 whakarea te wā pupuri o te waikawa tranexamic
Te pai o te punaha
Tauira: Te otinga pai o te punaha
Nga whakaritenga e tika ana
Whakatau: NLT 2.0 i waenga i te Waikawa Tranexamic me te 0.002 mg/mL o te waikawa tranexamic pūhui C
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o ia poke takitahi i te wahanga o te Waikawa Tranexamic i tangohia:
Hua = (rU/rS) × (CS/CU) × (0.1F)
rU = te whakautu teitei mo ia poke mai i te otinga Tauira
rS = te whakautu teitei mo te waikawa tranexamic mai i te otinga Paerewa
CS = te kukū o te USP Tranexamic Acid RS i te otinga Paerewa (µg/mL)
CU = te kukū o te Waikawa Tranexamic i te Tauira otinga (mg/mL)
F = tauwehe whakautu whanaunga (tirohia te Ripanga poke 1)
Paearu whakaae
Nga poke takitahi: Tirohia te Ripanga poke 1.
Tapeke poke: NMT 0.2%
[Tuhipoka-Whakaarohia te tihi iti iho i te 0.025%.]
Ripanga poke 1
Ingoa Wā Pupuri Whanaungatanga Whakautu Paanga Paearu Whakaaetanga, NMT (%)
Aa 2.1 1 0.1 pūhui whai pānga waikawa tranexamic
Puhui hono waikawa tranexamic Bb 1.5 1.2 0.2
Pūhui pātahi waikawa tranexamic Cc 1.1 0.005 0.1
Waikawa Tranexamic 1.0 1.0 —
Pūhui pātahi waikawa tranexamic Dd 1.3 0.006 0.1
he trans,trans-4,4¢-(Iminodimethylene)di(cyclohexanecarboxylic) waikawa.
b cis-4-(Aminomethyl) waikawa cyclohexanecarboxylic.
c (RS)-4-(Aminomethyl) cyclohex-1-enecarbocylic acid.
d 4-Aminomethyl benzoic acid.
NGA WHAKAMATAUTANGA
• Ngaronga i te whakamaroke <731>: Me whakamaroke 1.00 g i te 105 i raro i te korehau mo te 2 haora.Ka ngaro te NMT 0.5% o tona taumaha.
HE WHAKAMAHI ATU
• Te Whakapai me te Rokiroki: Whakaorangia ki roto i nga ipu kiki, ka penapena ki te mahana kaua e neke atu i te 30.
• Paerewa Tohutoro USP <11>
USP Tranexamic Acid RS Pāwhiri ki te Tiro Hanganga
USP Tranexamic Acid Related Compound C RS
(RS)-4-(Aminomethyl)cyclohex-1-enecarbocylic acid.
C8H13NO2 155