He aha ka ʻokoʻa ma waena o Apis a me Pharmaceutical Intermediates?

ʻO nā mea waena lāʻau lapaʻau a me nā API no ka ʻāpana o nā kemika maikaʻi. ʻO nā mea waena he mau mea i hana ʻia ma ke kaʻina hana o nā API e pono e hoʻololi hou i ka molekala a i ʻole ka hoʻomaʻemaʻe ʻana e lilo i API. Hiki ke hoʻokaʻawale a hoʻokaʻawale ʻole ʻia nā mea waena. (Manuahi: Hoʻopili wale kēia alakaʻi i nā mea waena a ka hui e wehewehe ai i hana ʻia ma hope o ka hoʻomaka ʻana o ka hana API.)

Active pharmaceutical ingredient (API): ʻO kēlā me kēia mea a i ʻole hui pū ʻia o nā mea i manaʻo ʻia no ka hoʻohana ʻana i ka hana ʻana i ka lāʻau lapaʻau a, ke hoʻohana ʻia i ka hana ʻana i kahi lāʻau lapaʻau, lilo ia i mea hana i loko o ka lāʻau. He hana pharmacological ia mau mea a i ʻole nā ​​hopena pololei ʻē aʻe i ka maʻi maʻi, ka mālama ʻana, ka hōʻoluʻolu o nā hōʻailona, ​​​​ka mālama ʻana a i ʻole ka pale ʻana i nā maʻi, a i ʻole hiki ke hoʻopilikia i nā hana a me nā hale o ke kino. ʻO nā API nā huahana ikaika i hoʻopau i ke ala synthesis, ʻoiai ʻo nā mea waena nā huahana ma kahi o ke ala synthesis. Hiki ke hoʻomākaukau pololei ʻia nā API, ʻoiai hiki ke hoʻohana wale ʻia nā mea waena e synthesize i ka pae aʻe o ka huahana. Ma o waena wale nō e hiki ke hana ʻia nā API.

Hiki ke ʻike ʻia mai ka wehewehe ʻana he mau huahana koʻikoʻi nā waena i ke kaʻina hana mua o ka hana ʻana i nā API a loaʻa nā ʻano like ʻole mai nā API. Eia kekahi, aia nā ʻano hoʻāʻo no nā mea maka i ka Pharmacopoeia, akā ʻaʻole no nā mea waena. Ma ke kamaʻilio ʻana e pili ana i ka palapala hōʻoia, i kēia manawa koi ʻo FDA i nā mea waena e hoʻopaʻa inoa, akā ʻaʻole ʻo COS. Eia nō naʻe, pono e loaʻa i ka faila CTD kahi wehewehe kaʻina hana o ka waena. Ma Kina, ʻaʻohe koi GMP pono no nā mea waena.

ʻAʻole pono nā mea waena lāʻau lapaʻau i nā laikini hana e like me nā API. He haʻahaʻa nā mea pale i ke komo ʻana a paʻakikī ka hoʻokūkū. No laila, ʻo ka maikaʻi, ka nui a me ka pae hoʻokele ke kumu no ke ola a me ka hoʻomohala ʻana o nā ʻoihana. ʻO ka piʻi nui ʻana o ka hoʻoikaika ʻana i ka mālama ʻana i ke kaiapuni i kumu hoʻi i nā ʻoihana liʻiliʻi e haʻalele mālie mai ke kahua hoʻokūkū, a manaʻo ʻia e piʻi wikiwiki ka ʻoihana.