Igama Lomkhiqizo: Tranexamic Acid 98% by HPLC
Inombolo ye-CAS:1197-18-8
I-Molecular Formula: C₈H₁₅NO₂
Isisindo samangqamuzana: 157.21 g/mol
Ubumsulwa: ≥98% (HPLC)
Ukubukeka: I-crystalline powder emhlophe
Isitoreji: +4°C (isikhathi esifushane), -20°C (isikhathi eside)
Isicelo: Ezemithi, Izimonyo, Ucwaningo
1. Uhlolojikelele lomkhiqizo
I-Tranexamic Acid (TXA), i-synthetic lysine analog, isetshenziswa kabanzi njenge-ejenti ye-antifibrinolytic ukunciphisa ukopha ezilungiselelweni zokuhlinzwa nokuhlukumezeka. Lo mkhiqizo ukhiqizwa ngaphansi kokulawulwa kwekhwalithi okuqinile, okuqinisekisa ukuhlanzeka okungu-≥98% njengoba kuqinisekiswe i-High-Performance Liquid Chromatography (HPLC). Isakhiwo sayo samakhemikhali (trans-4-(aminomethyl)cyclohexanecarboxylic acid) kanye nokuzinza okuphezulu kuyenza ifanelekele ukusetshenziswa okuhlukahlukene, okuhlanganisa:
- Ukusetshenziswa Kwezokwelapha: Ukulawula ukopha, ukwelashwa kokulimala kwengqondo okubuhlungu (TBI).
- Izimonyo: Okhilimu abamhlophe besikhumba abaqondise ukuguquguquka kombala.
- Ucwaningo: Ukuthuthukiswa kwendlela yokuhlaziya kanye nezifundo ze-pharmacokinetic.
2. Izakhiwo Zamakhemikhali Nezemvelo
- Igama le-IUPAC: 4-(Aminomethyl)cyclohexane-1-carboxylic acid
- AMAKHAYA: NC[C@@H]1CCC@HC(=O)O
- Ukhiye we-InChI: InChI=1S/C8H15NO2/c9-5-6-1-3-7(4-2-6)8(10)11/h6-7H,1-5,9H2,(H,10,11)/t6-,7
- Indawo Encibilikayo: 386°C (dec.)
- Ukunyibilika: Kuncibilika emanzini (1N HCl, amabhafa alungiswe i-pH), i-methanol, ne-acetonitrile.
3. Ukuqinisekisa Ikhwalithi
3.1 Ukuhlaziywa kwe-HPLC
Indlela yethu ye-HPLC iqinisekisa ukulinganisa okunembile kanye nephrofayili yokungcola:
- Ikholomu: XBridge C18 (4.6 mm × 250 mm, 5 μm) noma okulinganayo.
- Isigaba Seselula: I-Methanol:i-acetate buffer (20 mM, pH 4) (75:25 v/v).
- Isilinganiso sokugeleza: 0.8–0.9 mL/min.
- Ukutholwa: I-UV ku-220 nm noma ku-570 nm (i-post-derivatization ne-1% ninhydrin).
- Ukufaneleka Kwesistimu:
- Ukunemba: ≤2% CV yendawo ephakemeyo (6 okuphindaphindwayo).
- Ukubuyisela: 98-102% (80%, 100%, 120% amazinga ama-spiked).
3.2 Iphrofayili Yokungcola
- Ukungcola A: ≤0.1%.
- Ukungcola B: ≤0.2%.
- Ukungcola Okuphelele: ≤0.2%.
- I-Halides (njenge-Cl⁻): ≤140 ppm.
3.3 Ukuzinza
- I-pH Ukuzinza: Ihambisana nama-buffers (pH 2–7.4) kanye nezixazululo ezivamile ze-IV (isb, i-fructose, i-sodium chloride).
- Ukuzinza Kokushisa: Izinzile ku-37°C amahora angu-24 kumatikuletsheni webhayoloji.
4. Izicelo
4.1 Ukusetshenziswa Kwezokwelapha
- Ukunakekelwa Kwe-Trauma: Yehlisa ukushona kweziguli ze-TBI ngo-20% (uhlolo lwe-CRASH-3).
- Ukuhlinzwa: Kwehlisa ukulahleka kwegazi kwe-perioperative (ukuhlinzwa kwamathambo, ukuhlinzwa kwenhliziyo).
4.2 Izimonyo
- I-Mechanism: Ivimbela i-plasmin-induced melanogenesis ngokuvimba amasayithi abopha i-lysine.
- Amafomula: 3% okhilimu be-TXA be-melasma kanye ne-hyperpigmentation.
- Ukuphepha: Ukusetshenziswa kwezihloko kugwema izingozi zesistimu (isb, i-thrombosis).
4.3 Ucwaningo Nentuthuko
- Izindlela Zokuhlaziya:Ukwenziwa: Izifundo zokuguqulwa kwe-Prodrug ngaphansi kwezimo ezine-acidic.
- I-UPLC-MS/MS: Okokuhlaziya i-plasma (LOD: 0.1 ppm).
- I-Fluorimetry: Ukukhishwa nge-NDA/CN (ukusabela kwemizuzu emi-5).
5. Ukupakisha & Isitoreji
- Ukupakisha Okuyisisekelo: Izikhwama ze-aluminium ezivaliwe ezine-desiccant.
- Impilo yeshelufu: izinyanga ezingama-24 ku -20°C.
- Ukuthumela: Izinga lokushisa elizungezile (ligunyazwe amahora angu-72).
6. Ukuphepha Nokuhambisana
- Ukubamba: Sebenzisa i-PPE (amagilavu, izibuko) ukugwema ukuhogela/ukuthintwa.
- Isimo Sokulawula: Ihambisana ne-USP, EP, kanye ne-JP pharmacopeias.
- Ubuthi: LD₅₀ (ngomlomo, igundane) >5,000 mg/kg; non-carcinogenic.
7. Izikhombo
- Ukuqinisekiswa kokufaneleka kwesistimu kwe-HPLC.
- Ijika lokulinganisa kanye namaphrothokholi aphuma kokunye.
- Ukuqhathanisa indlela ye-UPLC-MS/MS.
- Ukusebenza kwezindleko ekunakekelweni kokuhlukumezeka.
- Ukuzinza kokwakheka kwezimonyo.
Amagama angukhiye: Tranexamic Acid 98% HPLC, Antifibrinolytic Agent, Skin Whitening, Trauma Care, UPLC-MS/MS, CRASH-3 Trial, Melasma Treatment
Incazelo ye-Meta: I-High-purity Tranexamic Acid (≥98% nge-HPLC) yokusetshenziswa kwezokwelapha, izimonyo, nocwaningo. Izindlela eziqinisekisiwe ze-HPLC, ukunakekelwa kokuhlukumezeka okungabizi kakhulu, kanye nokwakhiwa kwezihloko eziphephile. I-CAS 1197-18-8.