New to Dissolution? Here are some Resources to Learn From!
Friday, August 11, 2023
Control Limit (CL) Vs Specification Limit(SL)
Control Limit (CL)
The control limit is a statistical concept used in quality control to determine the acceptable range of variation in a process.
It is defined as the upper and lower limits within which a process is considered to be under control.
If data points fall outside these limits, it indicates that the process is out of control and requires investigation and corrective action.
Specification Limit (SL)
A specification limit refers to the maximum or minimum acceptable value for a particular characteristic or parameter of a product or process.
It is commonly used in quality control to ensure that products meet certain standards or requirements.
#qualitycontrol
Wednesday, August 9, 2023
HPLC Method Development and Quantification of Favipiravir in Both Bulk and Solution Form
Abstract
Favipiravir (FVP) structurally is an analog of pyrazine and showed its antiviral actions against a diverse species of viruses. Due to this fact, it was chosen as a potential candidate to be further investigated to cure COVID-19. A simple, accurate, rapid, precise, high-performance liquid chromatography (HPLC) method has been established for quality control assurance of FVP in pharmaceutical preparations. Column no C8 (150 mm × 4.6 mm; 5 μm) was used for such separation analysis. A combination of acetonitrile and phosphate buffer was used in 10:90 ratios as the mobile phase (90:10, v/v) having a flow rate of 1 mL / min. further, it was detected at 220 nm, and the temperature was maintained at 25 °C. The run time was then set at 10 min. A linear relationship of R 2 0.998 was confirmed while drawing a graph between FVP concentration and peak area that has a concentration range of 40-200 ppm. The developed method is sensitive (limits of detection and quantification are 1.83 ppm and 5.75 ppm respectively). Three injections at concentrations of 80,100 and 120 (ppm) were injected the same day to ensure the precision of the method. The prepared solution remains stable for 24 h. The suggested method has been successfully useful for the quantification of FVP in pharmaceutical formulations
For more information
check below link
https://www.researchgate.net/publication/365131405_HPLC_Method_Development_and_Quantification_of_Favipiravir_in_Both_Bulk_and_Solution_Form?utm_source=twitter&rgutm_meta1=eHNsLTZST3FabjFIWnZPRUpXbDR6TTVvM3pMdmdVZkNCK2ZIQmpwbWxIMmw2Y2V6cStPTzEyVW8xYnJZUFpzRnVvaDlDOUhRY2Z4LzdGUENhNTZraGRtMU5Pdz0%3D
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Causes Of Pressure Fluctuations in HPLC
Pressure fluctuations in high-performance liquid chromatography (HPLC) can lead to issues with the system's stability and performance. S...
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Abstract Favipiravir (FVP) structurally is an analog of pyrazine and showed its antiviral actions against a diverse species of viruses. Du...
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Purpose The purpose of this SOP is to develop an analytical method to test defined characteristics, of the finished pharmaceutical product, ...
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How to avoid gas trouble … well, in your HPLC at least. If you do not degas your mobile phase, then: - tiny bubbles in your HPLC’s fluidi...
Dissolution is an area where I've found that training tends to be lacking. In many companies, dissolution is taught to a chemist from another chemist - and the fundamentals of dissolution can be missed. Luckily, there are several resources to learn the basics of dissolution and help you to understand not only what you're doing in dissolution - but why and how you are doing it the way that you are.
Depending on how you prefer to learn, here are some good ways to elevate your knowledge.
First, I recommend starting with USP <711> Dissolution. This isn't a long chapter, and I think it is important to start with a strong foundation.
Next, there are some different free resources available to help you learn as well. If you prefer learning by webinars, there are many dissolution webinars available at: https://lnkd.in/gw9qrUD
Many of those webinars are ones I've put together and have information I feel is meaningful and relevant for the topics. If you're just starting out, go to the Dissolution: Foundation to Innovation Series and begin with Fundamentals.
If you'd like a more interactive training, Agilent has a free fundamentals training at: https://lnkd.in/eMhmJM8w
Much of that material was put together by Bryan Crist, who has been a mentor to me for many years.
Want to see what's going on with dissolution? LinkedIn can be helpful there, and there are dissolution and pharma focused groups to stay up to date. Dissolution Technologies magazine is great to check out as well at: https://lnkd.in/g_NeYhrK
Hopefully, you find I'm a helpful resource to you as well.