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Ulwazi
Iindidi
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Uhlalutyo lwendalo kunye namayeza: Isikhokelo sokugqibela sokukhetha i-vials & septa

Jul. 2325

Ukusuka kumanzi aqatha e-acidic kwiziyobisi ze-lipophilic, ukukhetha isampulu yesampulu ye-vial kungafunwa kwakhona okanye ukuphelisa i-pigger phantom. Esi sikhokelo sigqwetha imida yentsebenzo ye-SODA-I-SODAILICATER GULAS kwaye ibonelele ngezicwangciso ze-vial-and-septha ze-vial-neptas ze-septa ukuya kwi-Spining Grace Stures kwi-Assine Species-Ukuphelisa ukusebenzela i-mismatches.


Isampulu yakho kunye neemfuno zesicelo

Ishishini

Isampulu yesiqhelo

Iimfuno eziphambili zeZitya

Okusingqongileyo

Amanzi amdaka e-acidic (PH 1-3)

Ukunganyangeki; I-Lero Gath Leach

Pharma r & d

I-APIS ichithwe kwi-acetostitrile

Ukunganyangeki kwendalo; i-adsorption ephantsi

Uvavanyo lokutya

Iiplasitifers kwioyile yemifuno

I-Lipophilic uthenge; ukhuseleko lokukhanya



Ukuthelekiswa kwentsebenzo yezinto ezibonakalayo


Isixhobo

Iimpawu eziphambili

Ukuhambelana kwamachili

Iindleko (€ nganye kwi-vial)

Sebenzisa amatyala

Iglasi yesoda-lime

Ixabiso elincinci

pH 6-8 kuphela

~0.5

Iilebhu zokufundisa; Amanzi exesha elifutshane

I-borosililicicate ephantsi

Isiseko esisisiseko sokungakhathali (PH ≥4)

Hayi i-HF-okanye i-on enganyangekiyo

★★☆☆☆

Iindlela ze-phulc zamanzi

I-odumoilicicate

ph 0.5-10; I-Autoclavable kwi-120 ° C

I-PH PH; Ishushu

★★★☆☆

Pharma qc; Iisampulu ze-Bio

I-high-borosilicate

Eyona nto iphambili p0-14; ngokuzinzileyo

Zonke ii-Acids \ / iziseko; I-500 ° C ekwaziyo

★★★★☆

Trace \ / i-harsh-acid hlaluts

Qaphela: I-Opdium-Borosililicicate ihlangabezana ne-USP \ / ye-EP ebuyekayo yeglasi. I-CTE-Cote-Borosililicate CTE ≈3.3 × 10⁻⁶ \ / k vs. 9 × 10⁻⁶ \ / k kwiglasi eqhelekileyo.



Ukukhetha i-septa elungileyo


Uhlobo lweSeptum

Ukubhoboza Ubomi

Ukuhambelana kwamachili

Buyisela

Ilungele

I-ptfe \ / i-silicone portposite

I-15 ukuya kwi-20 ukubhoboza

I-AIDD, iziseko, izinyibilikisiweyo eziphakathi

I-DMF inokulibazisa

I-HPPC AutoMampler isebenza

I-ptfe

Ukusetyenziswa kancinci

Zonke izinyibilikisi eziphilayo

Ukutywinwa kakubi

I-GC-MS Harddied Assoed

Phinda wafumana i-silicone

30+ Hiercings

I-acid ebuthathaka \ / iziseko (PH 3-10)

Shushu kwi-acetone

Izikrini eziphezulu



Iingcebiso ze-Vial & Septa ngesampula


Uhlobo lwesampulu

I-vial enconywayo

Ukhetho lweSeptum

Umngxunya ukuphepha

Amanzi amdaka omzi-mveliso (ph 1.5)

I-vial-borosilicicate vial vial

Mhlophe ptfe \ / i-silicone portposite

Ungaze usebenzise i-soda-lime (inyibilike kwi-24 h)

Ukungcola kweziyobisi kwi-Acetostitrile

I-vial-borosililicicate vial

Iblue ebomvu ye-ptfe

I-borosililicate esezantsi ikhokelela ekutsaleni

Ioyile yemifuno

I-Amber ephezulu-Borosililicate

Phinda wafumana i-silicone

Iglasi ecacileyo ifuna ukhuseleko lokukhanya

Ukufundisa ii-buffers (ukungathathi hlangothi)

I-soda-lime glass vial

I-Silicone esemgangathweni

Kuphela kwiisampulu zexesha elifutshane, ezingathathi hlangothi



Isifundo setyala: Indlela yokudlulisela ukusilela kwi-pharma


  • Iseti yoqobo:

    • Isampuli: API kwi-0.1% fomuc acid \ / Acetotitrile (1: 1)

    • Ikhontelo: i-vial-borosililicicate vial + ye-silicone esezantsi ye-septum

  • Imiba:

    • Iincopho ezingaziwayo zivele kwinaliti # 3 (i-silicone ye-leageed)

    • Umxholo we-API wehliswa nge-12% emva kwe-72 h (i-adsorve yeglasi)

  • Isisombululo:

    • Phucula kwi-borosililicicate ye-vials ye-hydrolytic

    • Tshintshela kwi-PtFE \ ptfe \ / I-Silicone ye-septa (i-Pre-Poierce 5 ×)

  • Iziphumo:

    • I-phantom piks isuse

    • Uvavanyo loVavanyo lwe-0.8%



Iqhosha lezitshixo


  • I-harsh acid → i-surosililicilate ye-right

  • Ukuthobela i-Pharma

  • Iisampulu ezingathathi cala zexesha elifutshane → iSoda-Lime

  • I-Septa Chemistry> Ukubhoboza Ubomi

Izalathiso zedatha:

  • I-USP <660> Uvavanyo lwe-Inforlig yeGlass

  • Ingxelo ye-CMA-Eqinisekisiweyo

Ngesi sikhokelo, utshatisa i-vial yakho ye-vial kunye ne-septum kwi chemistry-uphephe ukubuyisela ixabiso kwakhona kwaye kuqinisekiswe iziphumo zokubuyiselwa kuhlalutyo lwendalo esingqongileyo kunye nohlalutyo lwamayeza.




Umbuzo