The Cubis II lab balance, plus the MCA high-end 7" display and the specific QApp pharma package, provide all the features necessary for a full pharma-compliant lab balance system.
This configuration of the Cubis II has all the technical controls you need to comply with FDA directive 21 CFR, Part 11 and EU Annex 11. Full compliance is achieved with additional procedural controls and systems for long-term data.
Data generated by the Cubis® II follow the key principles defining data integrity standards for accurate and reliable paper and electronic records as defined by ALCOA (+). Modern data handling enables safe storage in various ways.
For quantitative HPLC, it is essential to prepare a standard series with defined concentrations. Manual number crunching and weighing of solids for predefined solvent volumes is error-prone and time-consuming and can waste valuable materials and resources.
The Cubis® MSA individual system with Q-App software from Sartorius provides a solution: The system automatically corrects the solvent volume to the appropriate value, eliminating the need to reach the precise target weight. At the end of the procedure, the weight of the compound(s) and solvents is used to calculate the verified concentration(s) and the verified volume of the standard prepared.
See how the automated capabilities of the Cubis MSA system with gravimetric monitoring can simplify your workflow.
The quality of your solvent is critical to your HPLC analysis; trace contaminants can give you "ghost" or "phantom peaks."
Some labs use deionized or distilled water for HPLC–but these still have organic contaminants.
You can either purchase ultrapure water from a manufacturer—and then store it–or produce it on-site using a water purification system, as needed. We evaluated our arium pro VF water purification system for use in HPLC analysis and found:
Biopharmaceutical samples may have insoluble protein particles from their production processes, which must be removed before HPLC analysis. Filtration is a highly effective removal method because it can remove all particles. Traditional filtration can be time- and labor-intensive, given that large sample numbers are required for release testing of biopharmaceuticals.
We developed a novel, multiplexed filtration device (Claristep®) and tested it in a head-to-head comparison with regular small volume sample preparation for four biologic drug products. We found that Claristep can significantly reduce your sample preparation time.
Liquid chromatography–mass spectrometry (LC–MS) is a major analytical tool for the analysis of blood, urine, and other biological samples. However, after almost two decades of development, LC–MS-based metabolomics face hindrances in their application to the life sciences.
The presentation discusses those hindrances and recommends possible solutions to overcome them.
Key Learning Objectives:
Learn more about Sartorius’s portfolio of tools and technologies as they relate to the QC sample prep workflow.