Sample Preparation for Quality Control

Sample Prep Solutions for HPLC & More

Quality Control (QC) Is a Critical Step in the Pharmaceutical and Biopharmaceutical Industry

Every pharmaceutical manufacturer must demonstrate that their products are consistently manufactured, safe, potent, and pure. The number of tests that must be run by QC labs continues to rise to meet the ever-increasing QC requirements of global regulatory agencies.

Our analytical sample preparation solutions combine our legendary quality and reliability with our design wisdom to provide the very best in high-pressure liquid chromatography (HPLC), liquid chromatography–mass spectrometry, ion chromatography (LC-MS, IC), or inductively coupled plasma mass spectrometry (ICP-MS) filtration solutions.

  • Fast, simple, & economical
  • Low retention volumes & maximal recoveries
  • Almost zero leachables or extractables

Increase the Reproducibility of Your QC Results in 4 Easy Steps

Preparation of Solvents

Cubis® high-capacity micro balances for preparation of calibration standards in the pharmaceutical laboratory

Preparation of Standards

Pipetting

Filtration

Cubis® II - Pharma Compliant by Design
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Pharma Compliant Weighing and Sample Management

In the biopharmaceutical industry, scientific innovations are occurring very rapidly and are affecting all aspects of drug development and manufacturing, including the regulatory framework. As a laboratory balance manufacturer, we are committed to develop products which integrate the newest technologies and follow the latest pharmacopeia requirements. 

Quality Control in the biopharmaceutical industry includes the testing of raw materials, product intermediates and final drug products to ensure they meet the specifications related to their safety, stability, and efficacy. Typical quality control processes that we support with our high-end laboratory balances include sample preparation and management. See how we can address your weighing challenges in your QC process.

Sartorius Solutions for Laboratory Weighing

Pharma Compliant Weighing

Sartorius’s Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA).

The Cubis® II balance, with the Pharma package, contains all the technical controls to support full compliance with common regulations.

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Intuitive Workflows Ensure Safety

Cubis® II balances were designed for intuitive operation, aided by intelligent assistant systems. This not only includes an on-board QApp center but other features like status center, gesture control, automated motorized leveling and isoCal function, build-in ionizer, climate module, which all contribute to the correct usage of the balance.

This guarantees a higher degree of repeatability of the different workflows, while lowering the probability of human error during the measurement steps.

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Watch the video to learn more about HPLC Sample Preparation

Pharma Compliant Weighing Resources

21 CFR Part 11 Compliance Checklist

The Cubis®️ II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full compliance...

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Magnetism - An Influencing Factor on Weighing

Magnetism and electricity are natural phenomena, which have been known since ancient times. In 1820, Danish physicist Hans Christian Oersted...

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Integration of Sartorius Cubis® II into STARLIMS™ from Abbott...

Direct instrument integration into a LIMS is an essential task to reduce the need for manual recording, which negates the potential for errors...

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Formulation QApps Using a Database with Cubis®️ II

This is the use case description for the QApps Formulation flexible tare and Formulation single vessel. Both of these QApps have the ability to...

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Pipette Check to Standard DIN with Cubis®️ II

According to Standard DIN EN ISO 8655-2 volumetric measuring instruments such as piston pipettes must be checked at regular intervals but at...

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Tablet Check: Check of Tablets and Capsules with Cubis® II

According to European pharmacopoeia to ensure the consistency of dosage units tablets and capsules containing 25 mg or more of an active...

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Effects of Static Electricity on Analytical Weighing

Among the various options for eliminating static electricity during analytical weighing, there are simple, low-cost measures available. However...

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Sample Prep Quality Control Resources

Impact of the Claristep® Filtration System on Recovery and...

We tested the novel filter device Claristep® for the preparation of protein samples containing one of four different biotherapeutic molecules. In...

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Ultrapure Water for HPLC Analysis

The quality of a solvent is often decisive for the reliability of an HPLC analytical run, as the presence of trace contaminants during gradient...

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Brochure: Solutions for Pharmaceutical Sample Prep Quality Control

PDF 2.9 MB

Non-optimized Sample Prep

Chromatogram with pronounced background noise and peak tailing

In HPLC analysis, problems originating from sample preparation can occur.

  Possible blockage of your HPLC column

  Lower sensitivity of your HPLC column

  Peak Tailing

  More false-positive peaks

  Higher background noise

  Leachables

Optimized Sample Prep

Chromatogram with a stable baseline and symmetrical peaks

Using Sartorius products to prepare samples for HPLC prevents the usual problems from occurring and permits higher analytical accuracy to be attained.

  • No blockage of your HPLC column
  • Higher sensitivity of your HPLC column
  • Higher accuracy
  • Fewer false-positive peaks
  • Less background noise
  • No leachables

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