Orukọ ọja: Tranexamic Acid 98% nipasẹ HPLC
CAS No.:1197-18-8
Fọọmu Molecular: C₈H₁₅NO₂
Iwọn Molecular: 157.21 g / mol
Mimọ: ≥98% (HPLC)
Irisi: White crystalline lulú
Ibi ipamọ: +4°C (akoko kukuru), -20°C (igba pipẹ)
Ohun elo: Elegbogi, Kosimetik, Iwadi
1. ọja Akopọ
Tranexamic Acid (TXA), afọwọṣe lysine sintetiki, jẹ lilo pupọ bi oluranlowo antifibrinolytic lati dinku ẹjẹ ni awọn eto iṣẹ abẹ ati ibalokanjẹ. Ọja yii jẹ iṣelọpọ labẹ iṣakoso didara ti o muna, aridaju mimọ ti ≥98% bi a ti rii daju nipasẹ Chromatography Liquid Liquid Performance (HPLC). Ilana kemikali rẹ (trans-4- (aminomethyl) cyclohexanecarboxylic acid) ati iduroṣinṣin giga jẹ ki o dara fun awọn ohun elo oniruuru, pẹlu:
- Lilo iṣoogun: Iṣakoso iṣọn-ẹjẹ, itọju ọpọlọ ipalara (TBI).
- Kosimetik: Awọn ipara-funfun awọ ara ti o fojusi hyperpigmentation.
- Iwadi: Idagbasoke ọna itupalẹ ati awọn ẹkọ elegbogi.
2. Kemikali ati ti ara Properties
- Orukọ IUPAC: 4- (Aminomethyl) cyclohexane-1-carboxylic acid
- SILE: NC [C @ H] 1CCC@HC(=O)O
- Bọtini 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
- Oju Iyọ: 386°C (oṣu kejila)
- Solubility: Tiotuka ninu omi (1N HCl, pH-atunse buffers), methanol, ati acetonitrile.
3. Didara Didara
3.1 HPLC Analysis
Ọna HPLC wa ṣe idaniloju iwọn kongẹ ati profaili aimọ:
- Ọwọn: XBridge C18 (4.6 mm × 250 mm, 5 μm) tabi deede.
- Ipele Alagbeka: kẹmika kẹmika: ifipamọ acetate (20 mM, pH 4) (75:25 v/v).
- Oṣuwọn Sisan: 0.8-0.9 mL / min.
- Iwari: UV ni 220 nm tabi 570 nm (ifiweranṣẹ-ifiweranṣẹ pẹlu 1% ninhydrin).
- Ibamu Eto:
- Ipese: ≤2% CV fun agbegbe ti o ga julọ (awọn ẹda 6).
- Imularada: 98-102% (80%, 100%, 120% awọn ipele spiked).
3.2 Profaili aimọ
- Aimọ A: ≤0.1%.
- Aimọ́ B: ≤0.2%.
- Lapapọ Awọn aimọ: ≤0.2%.
- Halides (bi Cl⁻): ≤140 ppm.
3.3 Iduroṣinṣin
- Iduroṣinṣin pH: Ni ibamu pẹlu awọn buffers (pH 2-7.4) ati awọn ojutu IV ti o wọpọ (fun apẹẹrẹ, fructose, iṣuu soda kiloraidi).
- Iduroṣinṣin Gbona: Iduroṣinṣin ni 37°C fun awọn wakati 24 ni awọn matrices ti ibi.
4. Awọn ohun elo
4.1 Iṣoogun Lilo
- Itọju Ẹjẹ: Dinku iku ni awọn alaisan TBI nipasẹ 20% (idanwo CRASH-3).
- Iṣẹ abẹ: Dinku isonu ẹjẹ alagbeegbe (orthopedic, awọn iṣẹ abẹ ọkan).
4.2 Kosimetik
- Ilana: Idilọwọ melanogenesis ti plasmin-induced nipa didina awọn aaye lysine-abuda.
- Awọn agbekalẹ: 3% awọn ipara TXA fun melasma ati hyperpigmentation.
- Aabo: Lilo agbegbe yago fun awọn ewu eto (fun apẹẹrẹ, thrombosis).
4.3 Iwadi & Idagbasoke
- Awọn ọna Analitikali:Sinthesis: Awọn iwadii interconversion Prodrug labẹ awọn ipo ekikan.
- UPLC-MS/MS: Fun itupalẹ pilasima (LOD: 0.1 ppm).
- Fluorimetry: Iyasọtọ pẹlu NDA/CN (iṣeduro iṣẹju 5).
5. Iṣakojọpọ & Ibi ipamọ
- Iṣakojọpọ akọkọ: Awọn baagi aluminiomu ti a fi idii pẹlu desiccant.
- Igbesi aye selifu: Awọn oṣu 24 ni -20°C.
- Gbigbe: Iwọn otutu ibaramu (ti a fọwọsi fun awọn wakati 72).
6. Ailewu ati Ibamu
- Mimu: Lo PPE (awọn ibọwọ, awọn goggles) lati yago fun ifasimu/olubasọrọ.
- Ipo Ilana: Ni ibamu pẹlu USP, EP, ati JP pharmacopeias.
- Majele ti: LD₅₀ (ẹnu, eku)>5,000 mg/kg; ti kii-carcinogenic.
7. Awọn itọkasi
- Eto ìbójúmu afọwọsi fun HPLC.
- Iṣatunṣe iwọn ati awọn ilana itọsẹ.
- UPLC-MS/MS ọna lafiwe.
- Imudara iye owo ni itọju ipalara.
- Iduroṣinṣin agbekalẹ ikunra.
Awọn ọrọ-ọrọ: Tranexamic Acid 98% HPLC, Aṣoju Antifibrinolytic, Ifunfun Awọ, Itọju Ẹjẹ, UPLC-MS/MS, Idanwo CRASH-3, Itọju Melasma
Apejuwe Meta: Acid Tranexamic ti o ni mimọ (≥98% nipasẹ HPLC) fun iṣoogun, ohun ikunra, ati lilo iwadii. Awọn ọna HPLC ti a fọwọsi, itọju ibalokanjẹ ti o munadoko, ati awọn agbekalẹ agbegbe ailewu. CAS 1197-18-8.
