ʻO Sodium Stearyl Fumarate (SSF) Pharmaceutical Lubricant | Hoʻohālikelike API kiʻekiʻe, Koho ʻē aʻe i ka Magnesium Stearate, GMP Grade

ʻO kā mākou Sodium Stearyl Fumarate (SSF) kahi lubricant lāʻau lapaʻau kiʻekiʻe i hoʻolālā kūikawā ʻia no nā papa a me nā capsule. ʻAʻole e like me ka magnesium stearate, hāʻawi ia i ka hoʻohālikelike API maikaʻi loa, paʻa i ka over-lubrication, a ʻaʻohe hopena maikaʻi ʻole ma ka bioavailability.He lubricant hydrophilic, semi-soluble ia e hāʻawi ana i ka paʻakikī papa kiʻekiʻe ma nā ikaika compression like a hoʻemi i ka hopena ma ka manawa disintegration.Kūlike me nā lāʻau lapaʻau USP-NF, EP, a me JP me ka hoʻopaʻa inoa CDE (F20190000009) a me ke kākoʻo DMF (38822). Pae hoʻohana i manaʻo ʻia: 0.5-3% w/wKūpono no ka hoʻopili pololei wikiwiki, nā papa effervescent, a me nā ʻano hana me nā API kūpono ʻole.

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Papa lāʻau lapaʻau Sodium Stearyl Fumarate (SSF)

ʻIke Huahana

ʻO Sodium Stearyl Fumarate (SSF) kahi lubricant lāʻau lapaʻau hana kiʻekiʻe i ʻike nui ʻia he koho ʻoi aku ka maikaʻi ma mua o nā lubricants kuʻuna e like me ka magnesium stearate a me ka talc.He paʻakai sodium ia o ka stearyl fumaric acid, e ʻike ʻia ana he pauka keʻokeʻo a keʻokeʻo paha me nā waiwai amphiphilic e hiki ai ke hoʻopili pono i ka palena i nā papa a me nā capsule..

ʻIke Huahana:

Inoa Kemika:Sodium Stearyl Fumarate
Helu CAS:4070-80-8
Helu Hoʻopaʻa Inoa CDE:F20190000009
Helu DMF:38822
Hoʻokō ʻana i ka Pharmacopoeia:USP-NF, EP, JP
Formula Molekala:C22H39NaO4
Kaumaha Molekala:390.53 g/mol

Nā Hiʻohiʻona Koʻikoʻi a me nā Pōmaikaʻi

1. Hoʻohālikelike API Kiʻekiʻe Loa

Hoʻoponopono i nā pilikia hoʻohālikelike i kū pinepine ʻia me ka magnesium stearate
ʻO nā kūlike ʻole API i hōʻike ʻia me ka magnesium stearate e komo pū me: Azathioprine, Cefaclor, Cilazapril, Clopidogrel, Diclofenac, Ibuprofen, Omeprazole, a me nā mea ʻē aʻe he nui.
He kūpono no nā ʻano hana kahi e hopohopo ai ka pili ʻole o nā kemika

2. Paʻa i ka Lubrication Nui

ʻAʻole e like me ka magnesium stearate, mālama ka SSF i ka hana ʻoiai me nā manawa kāwili lōʻihi
Hāʻawi i ka paʻakikī papa like a me ka disintegration me ka ʻole o nā hopena "over-lubrication"

3. Nā Waiwai Papa i Hoʻonui ʻia

ʻOi aku ka paʻakikīma nā ikaika compression like i hoʻohālikelike ʻia me nā lubricants ʻē aʻe
Ka hopena iki ma ka manawa hoʻokaʻawale- mālama i ka haki wikiwiki o ka papa
ʻAʻohe hopena maikaʻi ʻole ma ka bioavailability- hōʻoia i ka paʻa ʻana o nā ʻikepili hoʻokuʻu lāʻau

4. ʻAno Hydrophilic a me ka Semi-Soluble

ʻO ka lubricant wai-hoʻoheheʻe ʻia - 0.5 mg/100 mL ma 25°C, e hoʻonui ana i 20 g/100 mL ma 90°C
Loaʻa nā hopena i ke koena haʻahaʻa i loko o ka hopena, e kūpono ai nonā papa ʻālohilohi
Hoʻomaikaʻi i nā ʻano hoʻoheheʻe ʻana o nā API hiki ʻole ke hoʻoheheʻe ʻia

5. Nā Waiwai Kino Maikaʻi Loa