塞爾吉奧·瓜佐蒂
抽象的：
準確理解任何藥物成分的實質有助於確保藥物的充足性和病人的安全。多年來，保證藥品基本品質特性調查的說明策略和程序有了巨大的改進。 Dionex 離子色譜系統提供的配置普遍受到歡迎，並且由於這些 Dionex IC 系統的機械進展和優勢較少，其基礎不斷增加。
用於藥物 ID 的設備和技術及其與管理標準的一致性應該是可靠和精確的。顆粒色譜 (IC) 是分解各種藥物組合、藥物甚至體液以測定動態成分、追蹤天然或無機顆粒或極性物質中的污染物、賦形劑和代謝物的最受歡迎的技術。利用顆粒層析法，可以在單獨檢查中快速區分一些物質，並且同樣可以分離綜合比較分析物。透過此技術可以估計的分析物焦點範圍從 ng/L 轉變為速率。 IC 策略的另一個空間是可以使用各種洗脫框架和分區部分，從而能夠出於所有意圖和目的對各種分析物進行研究。此外，選擇適當的發現技術或測試安排策略可以消除範例網路的干擾影響。目前的 IC 框架大部分都強調內聯測試基礎工作以進行有用的活動。除了改進 IC 策略之外，機械化還透過限制人類幹預，顯著降低了污染和錯誤結果的風險。顆粒層析 (IC) 是測定各種藥物、藥物組合甚至體液中的動態成分、賦形劑和污染影響因素的方法，以及天然和無機顆粒或極性物質等代謝物。它可以在單獨的研究中在極短的時間內確定一些物質，甚至可以識別出綜合上相似的分析物。分析物的分組可以從 ng/L 變化到擴展百分比。可用的劃分片段和洗脫框架的大量選擇使得 IC 幾乎適用於任何類型的分析物。透過使用正確的範例規劃或選擇適當的識別技術，無疑可以避免範例網格帶來的干擾影響。線上測試安排是眾多尖端 IC 框架的一個要素，因為 IC 不斷進步的焦點主要集中在可用性上。儘管如此，舒適度並不是 IC 程式電腦化帶來的主要優勢：降低人體阻抗同樣意味著減少混淆和污染的可能性。
Particle Chromatography has become a fundamental apparatus of the pharmaceutical systematic scientist. The high affectability of the method, combined with the wide unique working reach made conceivable with current high-limit fixed stages makes it perfect for the examination of particles in pharmaceutical applications. The blend of inclinations and smothered conductivity location gives a ground-breaking screening device to the investigation of particles in tranquilize substances and in pharmaceutical plans, giving a premise to the examination of counterions, added substances and assembling results. Particle chromatography as we probably am aware it today started with the spearheading work of Small, Stevens and Bauman. It has been developed various fronts, presently covering an amazingly wide assortment of analytes, and has seen noteworthy upgrades in fixed stage plan, chromatographic execution, recognition affectability, silencer structure and electrolytic age of eluents. Particle trade chromatography was generally utilized in HPLC a long time before the approach of particle chromatography. Furthermore, even now there are the individuals who take the point of view that particle chromatography is basically an advertising ploy to cut out a specialty for a HPLC instrument with a particle investigation center. Notwithstanding, in all actuality while particle investigation can positively be practiced on a traditional HPLC, ideal execution and dependability direct unique structure contemplations which eventually bring about central instrumentation contrasts. For instance, it is notable that hardened steel isn't promptly consumed by soluble arrangements so it is enticing to recommend that anion examination utilizing carbonate-bicarbonate cushioned eluent frameworks ought to be promptly agreeable to use with standard tempered steel HPLC instrumentation. Be that as it may, truth be told, the defensive oxide film on the outside of passivated treated steel parts is assaulted by rehashed cycles among acidic and antacid arrangements, at last evacuating the passivation layer and rendering the hardened steel vulnerable to pitting consumption. Thus, devoted instrumentation reasonable for use with both acidic and fundamental eluent frameworks perform significantly more dependably when all wetted surfaces are made out of idle materials, for example, PEEK, KelF, and so on. Thus, particle chromatography has come to be a subdiscipline of HPLC with specific instrumentation, consumables and identifiers.
These progressions incorporate prevalent precision, high-throughput, improved dependability, and natural wellbeing concerns which altogether contribute towards the basic examination of the medication element of intrigue. IC fundamentally depends on stifled just as non-smothered conductivity recognitions for ionic species in pharmaceutical examples. Dionex IC frameworks can precisely break down different anions/cations in a solitary infusion, in this way, quickening the examination throughput. The profitability can be additionally improved by changing over the single channel framework to a double channel framework where two distinct examples can be simultaneously broke down. Latest progression, Consumables Device Monitor, can naturally distinguish and tracks the establishment time, use, and execution measurements of all the introduced IC consumables. This component can decrease any related vacation because of consumable establishment blunders and can even timetable preventive systems for upkeeps. Such savvy abilities can essentially improve the profitability just as diminish the weight on the investigators' time in a quick paced pharmaceutical research facility. All cutting edge IC frameworks can make eluents naturally, permitting the steady and solid creation of high immaculateness IC eluent focuses. The main routine reagent at that point required is high-immaculateness water. Subsequently, the instrument siphon seals and cylinders just come into contact with deionized water rather than acids and bases which can accelerate. This broadens the lifetime of siphon seals and cylinders, and altogether decreases the general siphon upkeep necessities.
Dionex ICS-6000 HPIC framework being able to create and run various strategies for a solitary example or for various examples is progressively significant for logical research facilities. A profoundly adaptable particle chromatography (IC) framework furnishes you with the opportunity to create, investigate, and run various strategies at the same time. Dionex IC frameworks are continually developing with the changing occasions and needs. Late IC frameworks are outfitted with a tablet supporting 11 distinct dialects with an instinctive interface. This tablet control empowers direct neighborhood control of the framework and its status. All these improved abilities and headways have just prompted the fruitful appropriation of IC for breaking down ionic species in pharmaceutical applications.
Biography:
Sergio Guazzotti 是 Thermo Fisher Scientific 離子色譜和樣品製備部門的高級全球行銷總監。在此之前，他還擔任 Thermo Fisher Scientific 氣相層析/氣相層析質譜分析全球行銷總監。他於 2008 年加入公司，擔任 HPLC 高級全球策略行銷經理，後來被任命為高級整合經理，協助 Dionex Corporation 併入 Thermo Fisher Scientific。在加入 Thermo Fisher Scientific 之前，他曾擔任 Nanostream, Inc. 的工程和技術服務副總裁。他擁有加州大學化學博士學位。
底部說明：這項工作部分在 2018 年 8 月 2 日至 3 日在西班牙巴塞隆納舉行的第六屆色譜和高效液相層析技術進展國際會議和展覽會上進行了展示。
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