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Falanqaynta Deegaanka & Dawooyinka: Tilmaanta ugu dambeysa ee lagu xusho Vials & Septa

Jul. 23aad, 2025

Laga soo bilaabo biyaha xoogga aadka ah ee loo yaqaan 'acidic' si acidic-ka si loo isticmaalo dawooyinka lipopophophilic-ka, xulashada saafiga khaldan ee muunadda ah waxay ku soo baxaan soosaarista ama kicinta saqafka pintomka. Tilmaamahan wuxuu ku faafiyaa xadka waxqabadka ee soodhada-lime iyo dhalada dabiiciga ah waxayna bixisaa istiraatiijiyado vial-iyo-sept ah


Shuruudahaaga Shaybaarkaaga & Codsigaaga

Warshad

Muunad caadi ah

Baahiyaha weelka muhiimka ah

Deegaan

Biyaha aashitada (ph 1-3)

Iska caabbinta jiirka; Liiska birta ee Zero

Pharma r & d

APIS ayaa ku milmay acetonitrile

Iska caabin dabiici ah; Xayeysiinta Hoose

Tijaabada cuntada

Qalabka caagga ah ee saliidda cuntada

Iswaafajinta liidata; Ilaalin fudud



Isbarbardhiga Waxqabadka Qalabka


Wax

Sifooyinka muhiimka ah

Isku-darka kiimikada

Qiimaha (€ € vial)

Adeegso kiisaska

Galaas soodhada-lime

Ugu yaraan qaali

ph 6-8 kaliya

~0.5

Barista shaybaarka; Biyo-gaaban

Hoos udhaca

Caabbinta asaasiga asaasiga ah (ph ≥4)

Maaha HF-ama saldhigga adag ee u adkaysta

★★☆☆☆

Biyaha caadiga ah ee HPLC

Dhex-dhexaad

ph 0.5-10; AutosLappeble At 120 ° C

FARSAMADA PH; kuleylka-jeermiska

★★★☆☆

Pharma Qc; Muunado noolaha ah

Sare-Borosalecate

Dheeraad ah PH 0-14; si dhakhso ah u deggan

Dhammaan aashitada \ / saldhigyada; 500 ° C Awoodda

★★★★☆

Raad raac \ / falanqaynta aashitada ee aashitada

FIIRO GAAR AH: Gawaarida Dhex-dhexaadka ah ee-Borosalistate-ka USP \ / Ex Heerarka Dhaqadaha Dacwada. CTE-BOSIALIT CTE ≈3.3 × 10⁻⁶ \ / k vs. 9 × 10⁻⁶ \ / k oo loogu talagalay galaaska caadiga ah.



Xulashada Sep-ka saxda ah


Nooca Septum

Burburinta nolosha

Isku-darka kiimikada

Dib u dhac

Ku habboon

Ptfe \ / silicone-ka silicone

15-20 marqaati

Aashitada, saldhigyada, dareeraha dhexdhexaad ah

DMF ayaa khiyaanayn kara

HPLC Autosampler ayaa ordaya

PTFE saafi ah

Hal adeegsi

Dhammaan dareeraha dabiiciga ah

Xadhiga liita

GC-MS MALOGENENED Assayds

Silicone-ka horay loo dhajiyay

30+ duuliyaha

Aashitada daciifka ah \ / saldhigyada (ph 3-10)

Barar acetone

Shaashadda sare ee wax soo saarka



Talooyinka Final & Septa ee muunad


Nooca muunad

Vial lagu taliyay

Xulashada Septus

Garsooyinka si looga fogaado

Biyaha wasakhda ah (PH 1.5)

Sare-Borosaile Cas oo cad

White PtFe \ / silicone-ka silicone

Weligaa ha u isticmaalin liin-lime (kala diri) 24 saac

Dawooyinka daroogada ee acetonitrile

Dhex-dhexaadka dhexdhexaadka ah

Pluf PTFE PTFE

Horyaalka Hoose-Borosailes ah oo loo yaqaan 'Peak'

Faa'iidooyinka saliida ee khudradda

Amber High-Borosalistacate

Silicone-ka horay loo dhajiyay

Galaas cad ayaa u baahan ilaalin fudud

Barista wax barista (dhexdhexaad ah)

Dharka-lime vial

Standard Silicone

Kaliya sanadaha muddada-gaaban, oo ah



Daraasadda kiiska: Qaabka loo habeeyo


  • Setup asalka ah:

    • Muunad: API gudaheeda 0.1% Foomka Acid \ / acetonitrile (1: 1)

    • Weelka: Lower-Porosaileit Vial + Heerka Setty ee Silicone

  • Arrimaha:

    • Horudhac aan la garanayn ayaa ka soo muuqday mudista # 3 (shaashadda silikone)

    • Maaddada API-da ayaa ku dhacday 12% ka dib 72 H (Qalabka dhalada)

  • Xalka:

    • Kor u qaad ilaa vials-ga galka-galka

    • U beddelo ptfe \ / silicone closite septa (pre-pre-pre-presited 5 ×)

  • Natiijooyinka:

    • Phantom Peaks ayaa la tirtiray

    • Kala duwanaanshaha Imtixaanka Xasiloonida <0.8%



Kale Takecaano


  • Aashitada adag → sare-borosaile

  • U hoggaansanaanta Phoncha → Dhexdhexaad-Borosalistate

  • Muunado-gaaban oo ka-hortagga ah → soodhada-lime

  • Septa Chemistry> Nolosha nolosha

Tixraacyada Xogta:

  • USP <660> Imtixaanada weelka dhalada

  • CMA-Xaqiijinta Qoraalka Laylaan

Tilmaamahan, la dhig vial-gaaga iyo septam-kaaga si aad u hesho kimistariga-ka fogaada dib-u-shaqeynta qaaliga ah oo hubi natiijooyinka soo saarida ee guud ahaan falanqaynta deegaanka iyo dawooyinka.




Su'aalo weydiinta