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Umgangatho olungileyo oPhezulu wePancreatin CAS 8049-47-6 ngexabiso eliPhezulu


  • Inombolo yeCAS:8049-47-6
  • IKHOWUDI ye-HS:3507.9090.90
  • Inkonzo Yefayile:IsiTshayina-GMP/EU-GMP/DMF/EU-DMF
  • Pharmacopoeia umgangatho:EP/USP/CP
  • Iinkcukacha zeMveliso

    Iithegi zeMveliso

    Umbutho wethu ugxininisa kulawulo, ukwaziswa kwabasebenzi abanetalente, kunye nokwakhiwa kweqela, ukuzama ngamandla ukuphucula umgangatho kunye nokuqonda uxanduva lwamalungu eqela.Umbutho wethu uphumelele iSatifikethi se-IS9001 kunye neSatifikethi se-CE saseYurophu soMgangatho oLungileyo woMgangatho oPhezulu wePancreatin CAS 8049-47-6 ngeXabiso Elihle, Ukubona kukholelwa!Siyawamkela ngokunyanisekileyo amathuba amatsha aphesheya ukuseta unxibelelwano lwenkampani kwaye silindele nokudibanisa unxibelelwano nabo bonke abaxumi ekudala basekwa.
    Umbutho wethu ugxininisa kulawulo, ukwaziswa kwabasebenzi abanetalente, kunye nokwakhiwa kweqela, ukuzama ngamandla ukuphucula umgangatho kunye nokuqonda uxanduva lwamalungu eqela.Umbutho wethu uphumelele iSatifikethi se-IS9001 kunye neSatifikethi se-CE saseYurophuI-China CAS 8049-47-6 kunye noMgangatho oPhezulu, Izisombululo zethu ziveliswa ngezona zinto zingcono kakhulu.Umzuzu ngamnye, sihlala siphucula inkqubo yemveliso.Ukuze kuqinisekiswe umgangatho ongcono kunye nenkonzo, ngoku sigxile kwinkqubo yokuvelisa.Siye sanconywa kakhulu liqabane.Sijonge phambili ekusekeni ubudlelwane boshishino nawe.

    Iinkcukacha

    1. Abalinganiswa: I-Pancreatin ngumgubo kancinane omdaka, o-amorphous okanye umdaka kancinci ukuya kwigranule enombala okhrimu.Iqulethwe yi-amylase, i-lipase kunye ne-protease.

    2. Ukukhutshwa Umthombo: Ipancreas yehagu.

    3. Inkqubo: I-Pancreatin itsalwa kwi-pancreas enempilo ye-porcine ngeteknoloji yethu yokukhupha iteknoloji ekhethekileyo.

    4 .Izibonakaliso kunye nokusetyenziswa: I-Pancreatin ngumxube wee-enzyme ezininzi zokugaya eziveliswa yi-pancreas ye-porcine.Ingasetyenziswa kwishishini lamachiza, ukusetyenzwa kokutya, ukuthambisa, ukuhlamba kunye nezinye iindawo, ezinoluhlu olubanzi lwezicelo.

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    Kutheni sisi?

    ·Iveliswe kwiworkshop yeGMP

    · Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D

    ·Imathiriyeli ekrwada iyalandeleka

    ·Thobela umgangatho wabathengi

    ·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla

    ·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.

    Inkcazo

    Izinto zovavanyo

    Inkcazo yeNkampani

    CP

    EP

    USP

    Abalinganiswa

    Umgubo

    Umgubo kancinane omdaka, oneamorphous

    Umgubo kancinane omdaka, oneamorphous

    Umgubo kancinane omdaka, oneamorphous

    Igranule

    Igranule emdaka kancinci ukuya kumbala wekhrim

    Igranule emdaka kancinci ukuya kumbala wekhrim

    Igranule emdaka kancinci ukuya kumbala wekhrim

    Ukuchongwa

    ————

    Iyahambelana

    ————

    Iimvavanyo

    Umxholo wamafutha

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP);≤ 6.0%(≥3USP)

    Ilahleko ekomisweni

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0% Yomile kwiVacuum 60℃, 4h

    Isinyibilikisi esishiyekileyo

    ————

    ≤ 0.5% Ngokungqinelana ne-EP(5.4)

    ≤ 0.5%Ngokungqinelana ne-USP(467)

    Ubungakanani besuntswana

    ————

    Ngokwe-EP(2.1.4&2.9.12)

    Ngokutsho kweUSP(811)

    Isivavanyi

    Iprotease

    ≥600U/g

    1.0~5.2Ph.Eur.U/mg

    100-450USP.U/mg

    Amylase

    ≥7000U/g

    12.0~80.0Ph.Eur.U/mg

    100~500USP.U/mg

    Lipase

    ≥4000U/g

    15.0–130Ph.Eur.U/mg

    10~90USP.U/mg

    Ukungcola kweMicrobial

    TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Iyahambelana

    Iyahambelana

    Iyahambelana

    Salmonella

    Iyahambelana

    Iyahambelana

    Iyahambelana

    Umbutho wethu ugxininisa kulawulo, ukwaziswa kwabasebenzi abanetalente, kunye nokwakhiwa kweqela, ukuzama ngamandla ukuphucula umgangatho kunye nokuqonda uxanduva lwamalungu eqela.Umbutho wethu uphumelele iSatifikethi se-IS9001 kunye neSatifikethi se-CE saseYurophu soMgangatho oLungileyo woMgangatho oPhezulu wePancreatin CAS 8049-47-6 ngeXabiso Elihle, Ukubona kukholelwa!Siyawamkela ngokunyanisekileyo amathuba amatsha aphesheya ukuseta unxibelelwano lwenkampani kwaye silindele nokudibanisa unxibelelwano nabo bonke abaxumi ekudala basekwa.
    Umgangatho olungileyoI-China CAS 8049-47-6 kunye noMgangatho oPhezulu, Izisombululo zethu ziveliswa ngezona zinto zingcono kakhulu.Umzuzu ngamnye, sihlala siphucula inkqubo yemveliso.Ukuze kuqinisekiswe umgangatho ongcono kunye nenkonzo, ngoku sigxile kwinkqubo yokuvelisa.Siye sanconywa kakhulu liqabane.Sijonge phambili ekusekeni ubudlelwane boshishino nawe.


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