Pharmacopoeia Standard Of Hydroxypropyl Methyl Cellulose

Hydroxypropyl Methylcellulose (HPMC) jẹ ohun elo elegbogi ti a lo lọpọlọpọ, ati pe didara rẹ ati awọn pato jẹ asọye nipasẹ ọpọlọpọ awọn oogun oogun ni ayika agbaye. Eyi ni diẹ ninu awọn iṣedede elegbogi fun HPMC:

Orilẹ Amẹrika Pharmacopeia (USP):

• Orilẹ Amẹrika Pharmacopeia (USP) ṣeto awọn iṣedede fun didara, mimọ, ati iṣẹ ti awọn eroja elegbogi ati awọn fọọmu iwọn lilo. Awọn ẹyọkan HPMC ni USP pese awọn alaye ni pato fun ọpọlọpọ awọn paramita gẹgẹbi idanimọ, idanwo, iki, akoonu ọrinrin, iwọn patiku, ati akoonu awọn irin eru.

European Pharmacopoeia (Ph. Eur.):

• European Pharmacopoeia (Ph. Eur.) pese awọn iṣedede fun awọn nkan elegbogi ati awọn igbaradi ni awọn orilẹ-ede Yuroopu. Awọn ẹyọkan HPMC ni Ph. pato awọn ibeere fun awọn paramita gẹgẹbi idanimọ, ayẹwo, iki, pipadanu lori gbigbẹ, iyoku lori iginisonu, ati ibajẹ microbial.

British Pharmacopoeia (BP):

• British Pharmacopoeia (BP) ni awọn iṣedede ati awọn pato fun awọn nkan elegbogi ati awọn fọọmu iwọn lilo ni UK ati awọn orilẹ-ede miiran. Awọn monographs HPMC ninu awọn ilana ilana BP fun idanimọ, idanwo, iki, iwọn patiku, ati awọn abuda didara miiran.

Pharmacopoeia Japanese (JP):

• Awọn Pharmacopoeia Japanese (JP) ṣeto awọn iṣedede fun awọn oogun ni Japan. Awọn ẹyọkan HPMC ninu JP pẹlu awọn ibeere fun idanimọ, iṣiro, iki, pinpin iwọn patiku, ati awọn opin microbial.

International Pharmacopoeia:

• International Pharmacopoeia (Ph. Int.) n pese awọn iṣedede fun awọn oogun ni kariaye, pataki fun awọn orilẹ-ede ti ko ni awọn oogun oogun tiwọn. HPMC monographs ni Ph. Int. pato awọn ilana fun idamọ, iṣiro, iki, ati awọn ipilẹ didara miiran.

Awọn Pharmacopoeias miiran:

• Awọn ajohunše Pharmacopoeial fun HPMC tun le rii ni awọn ile elegbogi ti orilẹ-ede miiran gẹgẹbi India Pharmacopoeia (IP), Pharmacopoeia Kannada (ChP), ati Pharmacopoeia ti Orilẹ-ede Eniyan ti Bangladesh (BPC).

Awọn akitiyan isokan:

• Awọn akitiyan isokan laarin awọn ile elegbogi ṣe ifọkansi lati ṣe deede awọn iṣedede ati awọn pato fun awọn eroja elegbogi ati awọn ọja ni kariaye. Awọn ipilẹṣẹ ifowosowopo gẹgẹbi Apejọ Kariaye lori Isọpọ Awọn ibeere Imọ-ẹrọ fun Iforukọsilẹ ti Awọn oogun fun Lilo Eniyan (ICH) ṣe iranlọwọ igbelaruge iduroṣinṣin ati dẹrọ iṣowo kariaye.

Ni akojọpọ, Hydroxypropyl Methylcellulose (HPMC) wa labẹ awọn iṣedede elegbogi ati awọn pato ti iṣeto nipasẹ awọn ajọ bii USP, Ph. Eur., BP, JP, ati awọn elegbogi ti orilẹ-ede miiran. Ibamu pẹlu awọn iṣedede wọnyi ṣe idaniloju didara, mimọ, ati iṣẹ ti HPMC ni awọn agbekalẹ oogun.