Amitriptyline Hydrochloride jẹ eroja elegbogi ti nṣiṣe lọwọ bọtini (API) ti a lo ninu awọn oogun antidepressant ati awọn itọju iṣakoso irora. Bi awọn kan gbẹkẹle olupese atiolupese ti Amitriptyline Hydrochlorideagbedemeji, a pese ga-didara aise ohun elo lati se atileyin isejade ti yi ibaraẹnisọrọ elegbogi yellow.
Awọn agbedemeji wa ni iṣelọpọ labẹ awọn iṣedede Iṣe iṣelọpọ Ti o dara (GMP), ni idaniloju mimọ, aitasera, ati ibamu pẹlu awọn ibeere ilana agbaye.
Kini idi ti o yan Jingye Pharmaceutical bi Olupese Rẹ?
Awọn Iwọn Didara Didara
GMP-ifọwọsi awọn ilana iṣelọpọ
Awọn ipele mimọ ti 99% tabi ti o ga julọ (ti jẹri nipasẹ idanwo HPLC/GC)
Awọn iwe-ipamọ pipe pẹlu Awọn iwe-ẹri ti Onínọmbà (COA), Awọn iwe data Aabo Ohun elo (MSDS), ati Awọn faili Titunto si Oògùn (DMF)
Adani Solusan
Ti o ni ibamu fun awọn ibeere agbedemeji pato
Awọn agbara iṣelọpọ olopobobo lati kilo si iwọn pupọ
Awọn aṣayan iṣakojọpọ rọ lati pade awọn iwulo rẹ
Gbẹkẹle Global Pinpin
Awọn aṣayan gbigbe daradara (afẹfẹ, okun, ati ifijiṣẹ kiakia)
Ṣe aabo awọn eekaderi pẹlu ibi ipamọ iṣakoso iwọn otutu nigbati o jẹ dandan
Ibamu pẹlu awọn iṣedede ilana pataki (FDA AMẸRIKA, EDQM, WHO-GMP)
Imọ ĭrìrĭ
Ju ọdun 10 ti iriri ni iṣelọpọ agbedemeji API
Iwadi igbẹhin ati ẹgbẹ idagbasoke fun iṣapeye ilana
Iṣakoso didara lile ni gbogbo ipele ti iṣelọpọ
Bọtini Amitriptyline Hydrochloride Intermediates A Pese
A ṣe amọja ni iṣelọpọ awọn agbedemeji pataki fun iṣelọpọ Amitriptyline HCl, pẹlu:
5- (3-Dimethylaminopropylidene) -5H-dibenzo [a, d] cycloheptene
10,11-Dihydro-5H-dibenzo[a,d] cyclohepten-5-ọkan
3- (10,11-Dihydro-5H-dibenzo[a,d] cyclohepten-5-ylidene) -N, N-dimethyl-1-propanamine
Agbedemeji kọọkan gba idanwo iṣakoso didara pipe (HPLC, NMR, MS) lati pade awọn iṣedede elegbogi (USP, EP, JP).
Awọn ohun elo ti Amitriptyline Hydrochloride
Amitriptyline HCl jẹ lilo pupọ ni:
Awọn oogun antidepressant
Itoju irora onibaje (irora neuropathic, fibromyalgia)
Idena migraine
Oogun ti ogbo fun awọn rudurudu ihuwasi ninu awọn ẹranko
Awọn agbedemeji wa jẹ ki awọn aṣelọpọ elegbogi ṣe agbejade ailewu ati munadoko awọn oogun orisun Amitriptyline.
Alabaṣepọ pẹlu Olupese Gbẹkẹle
Gẹgẹbi olutaja oludari ti awọn agbedemeji Amitriptyline Hydrochloride, a funni:
Idiyele idije (kan si wa fun agbasọ kan)
Aṣiri to muna ati aabo ohun-ini ọgbọn
Ipari
Yiyan olupese ti o gbẹkẹle fun awọn agbedemeji Amitriptyline Hydrochloride jẹ pataki fun ṣiṣe idaniloju didara oogun ati ibamu ilana. Pẹlu iṣelọpọ ifọwọsi-GMP wa, imọ-ẹrọ imọ-ẹrọ, ati pq ipese ti o gbẹkẹle, a jẹ alabaṣepọ ti o fẹ julọ fun awọn ile-iṣẹ oogun ni kariaye.
Akoko ifiweranṣẹ: Oṣu Kẹrin Ọjọ 30-2025