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He pai te ingoa o te Kaiwhakamahi mo Haina Kounga teitei Kallikrein CAS 9001-01-8 Pancreatic Kininogenase Kallikrein Paura


  • KAUPAPA NO.:9001-01-8
  • Waehere HS:3507.9090.90
  • Ratonga Kōnae:Hainamana-GMP, DMF
  • Paerewa Pharmacopoeia:JP/CP
  • Taipitopito Hua

    Tohu Hua

    Inaianei kei a matou he tohunga, he kaimahi mahi ki te tuku kaiwhakarato kounga teitei mo o taatau kaihoko.I te nuinga o te wa e whai ana matou i te kaupapa o nga kaihoko, e aro ana ki nga korero mo te ingoa pai o te Kaiwhakamahi mo Haina Kounga teiteiKalikreinCAS 9001-01-8 Pancreatic Kininogenase Kallikrein Paura, Ma te whanaketanga tere me o taatau kaihoko mai i Europe, United States, Africa me te ao katoa.Nau mai ki te toro ki to maatau wheketere me te mihi ki to ota, mo etahi atu patai kaua koe e mangere ki te whakapiri mai ki a maatau!
    Inaianei kei a matou he tohunga, he kaimahi mahi ki te tuku kaiwhakarato kounga teitei mo o taatau kaihoko.I te nuinga o te wa ka whai matou i te kaupapa o te kaihoko-arotahi, nga korero-arotahi moHaina Kininogenase Kallikrein, Kalikrein, Nau mai ki te toro ki ta maatau kamupene me te wheketere, he maha nga otinga e whakaatuhia ana i roto i ta maatau ruma whakaatu ka tutuki i to tumanako, i tenei wa, ki te watea koe ki te toro atu ki to maatau paetukutuku, ka ngana a maatau kaimahi ki te tuku i te ratonga pai rawa atu.

    Taipitopito

    1. Nga Tohu: Te paura ma, tata ma ranei, kaore he kakara.

    2. Puna Tangohanga: Porcine pancreas.

    3. Tukatuka: Ka tangohia mai te Kallidinogenase mai i te pancreas poaka hauora.

    4. Nga tohu me nga whakamahinga: Ka taea te whakamahi i tenei hua mo nga momo mate pukupuku me te cerebovascular, penei i te mate ngakau coronary, arteriosclerosis cerebral, thrombosis cerebral, raruraru tuku toto retinal me te mate vascular peripheral.He pai ake te rongoa ki nga rangahau tata nei mo te aukati i te microangiopathy mate huka moata me te nephropathy mate huka, ka taea te whakaheke i te whakaputanga albumin.Ko nga raraunga haumanu i te kainga me nga whenua o waho e kii ana ka taea e ia te whakanui ake i te mahi parāoa me te nui o te whakaputanga, me te whai hua whakaora i roto i te maimoatanga o etahi taangata tane.

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    He aha tatou?

    ·I hangaia i roto i te awheawhe GMP

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    · Ka kitea nga rauemi mata

    · Kia rite ki nga paerewa a nga kaihoko

    · Kaweake ki runga i te 30 whenua me nga rohe

    · He kaha ki te whakahaere punaha kounga penei i te US FDA, Japan PMDA, South Korea MFDS, etc.

    Whakatakotoranga

    Nga Tuemi Whakamatau

    Whakatakotoranga Kamupene

    CP

    JP

    Ngā Pūāhua

    Te paura ma, tata ma ranei, kaore he kakara

    He ma ki te paura parauri paku, he hongi, he ngoikore ranei

    Tautuhinga

    R (tere waiwai): 0.12~0.17

    R (tere waiwai): 0.12~0.16

    Waiwai Chromatography: He rite

    Ahau : ≤ 0.2

    Nga whakamatautau

    pH

    5.5~7.5(300wae/ml)

    5.5~7.5(1g/300ml)

    Te marama o te otinga

    Maamaa(2mg/ml)

    ————

    Ngako

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Uara: ≥ 0.8

    He matū rite trypsin

    ————

    Uara T:≤ 0.05

    Protease

    A280≤ 0.2

    A280≤ 0.2

    Ngaronga i te whakamaroke

    ≤ 5.0% (60 ℃ maroke i te korehau, 4h)

    ≤ 2.0% (60 ℃ maroke i te korehau, 4h)

    Te toenga i runga i te mura

    ≤ 3.0%

    ≤ 3.0%

    He mahi tuku-kini

    ————

    ≥ 500ng bradykinin rite / min / wae ia wae

    Maamaa

    ≥ 75% (mo te waha)

    ————

    ≥ 90% (mo te werohanga)

    Endotoxin huakita

    ≤ 2.5 EU/wae (mo te werohanga)

    ————

    Te whakamatautau

    Te ngohe ngohe

    ————

    ≥ 25 wae/mg

    Mahi motuhake

    ≥ 300 wae/mg pūmua (mo te waha)

    ≥ 100 wae/mg pūmua

    ≥ 600 wae/mg pūmua (mo te werohanga)

    Nga poke moroiti

    TAMC

    ≤ 1000cfu/g (mo te waha)

    ≤ 1000cfu/g

    ≤ 100cfu/g (mo te werohanga)

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Ka rite

    Ka rite

    Haramona

    Ka rite

    Ka rite

    Inaianei kei a matou he tohunga, he kaimahi mahi ki te tuku kaiwhakarato kounga teitei mo o taatau kaihoko.I te nuinga o te wa e whai ana matou i te kaupapa o nga kaihoko, nga korero-arotahi mo te ingoa pai o te Kaiwhakamahi mo Haina Kounga teitei Kallikrein CAS 9001-01-8 Pancreatic Kininogenase Kallikrein Paura, Ma te tere o te whakawhanaketanga me o taatau kaihoko mai i Europe, United States, Africa me te katoa i runga i te ao.Nau mai ki te toro ki to maatau wheketere me te mihi ki to ota, mo etahi atu patai kaua koe e mangere ki te whakapiri mai ki a maatau!
    He ingoa pai mo te KaiwhakamahiHaina Kininogenase Kallikrein, Kallikrein, Nau mai ki te toro ki ta maatau kamupene me te wheketere, he maha nga otinga e whakaatuhia ana i roto i to maatau whakaaturanga ka tutuki i to tumanako, i tenei wa, ki te watea koe ki te toro atu ki to maatau paetukutuku, ka whakamatau nga kaimahi hoko ki a koe ki te tuku i te ratonga pai rawa atu.


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