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We provide 

the Essential Value


We add value of your understanding of regulatory guidance on


Impurity

Extractables and Leachables

CCIT (Container closure Integrity testing)


Also, Saint-Gobain with Tubing and Bag as Single use system

SWISS BASEL, E&L SCHOOL Welcome KOREA CUSTOMER

🌐 Quality by Design Inc. - Your Trusted Partner in E&L Studies 🌐

At Quality by Design Inc., we pride ourselves on being at the forefront of the Extractables and Leachables (E&L) study landscape. Our comprehensive services cover:


🔍 Consultation on the current E&L study approach 

🔬 Critical assessment and evaluation 

📜 Extractables & Leachables study and profiling 

🧪 Identification & Toxicological evaluations 

🛡️ Risk and Safety assessments 

✅ Regulatory Registration support


Key Areas of Expertise:

  • Container closure systems like glass vials, stoppers, and related products.
  • Single-use systems and process contact materials.
  • All types of Medical Devices.

"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:

  • FDA, EMA, CHINA, KOREA, JAPAN, BRASIL, Türkiye(Turkey) and more.

Have an inquiry or need expert advice? 📩 Reach out to us at qbd@qbd.co.kr

For a more in-depth look at what we offer, visit our official website at www.qbd.co.kr

Let's navigate the complexities of E&L together! We look forward to partnering with you. 💼🌟


E&L and Pharmaceutical Regulatory Compliance AI 

의약품 인허가 관련 질문하시고 간단한 답변 받으실 수 있습니다.


큐비디 리뷰의견Semi-quantification

관리자
2024-10-31
조회수 604

Semi-quantification is an analytical approach used to estimate the concentration of analytes in a sample with a degree of accuracy that falls between qualitative and fully quantitative analysis. This method involves using surrogate standards to provide an analyte's concentration by accounting for the relative responses of the analyte and the surrogate substance.


In semi-quantitative analysis, the response factor of the surrogate standard is applied to the analyte, allowing for an estimation of concentration without the need for a specific calibration curve for each analyte. This approach is particularly useful when the exact analyte is not available as a standard or when rapid screening is required.


The process typically involves selecting a surrogate standard that closely resembles the analyte in terms of retention time and chemical properties. The response factor is then used to adjust the analyte's signal, providing an estimated concentration. This method is often employed in the initial stages of extractables and leachables testing to compare results against an Analytical Evaluation Threshold (AET).


2022_WILEY_Extractables and Leachables

 

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