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Pure success with Merck Millipore’s high-purity solvents

Pure success with Merck Millipore’s high-purity solvents

We let nothing come between you and your results. No impurities, no inconsistencies and no compliance concerns. When analyzing residual solvents in drug products using headspace gas chromatography (GC), our high-purity SupraSolv® solvents specify the maximum allowed concentration of every residual solvent defined by the ICH*. Thus, you’ll know that the concentration of class 1 residual solvents is never more than 1 μg/g. And to meet the demanding criteria of LC-MS applications, our LiChrosolv® hypergrade solvents are second to none in terms of purity, reproducibility and ionization efficiency. No matter what your application, high-purity solvents from Merck Millipore are the key to successful analysis.

 

Pure safety: SupraSolv® high-purity solvents for headspace GC
Since residual solvents in drug products pose a risk to human health, pharmaceutical companies are required to test all products and confirm that concentrations are below harmful limits. Permissible maximum values for residual solvents in drug substances are defined by the ICH* guideline Q3C “Impurities: Guideline for Residual Solvents”. Both the European Pharmacopoeia (Ph Eur) and United States Pharmacopoeia (USP) refer to this guideline, and recommend headspace GC as the method of choice. Although the technique is very precise and well accepted, its accuracy is highly dependent on the purity of the dissolving solvents used.

SupraSolv® solvents for headspace GC  are optimized for the analysis of residual solvents in drug substances, excipients, and drug products according to the ICH, Ph Eur and USP. Thanks to their superior baseline clarity and extremely low solvent residues, they eliminate any interference with your findings. All residual solvent classes defined in the ICH guideline are included in the specification, providing you with a precise purity window for your application. In addition, application tests are performed for every batch produced to make sure it meets your particular requirements. Developed in close cooperation with our customers and manufactured using unique processes, SupraSolv® solvents for headspace GC offer incomparable quality, reliability and, most importantly, safety.

  • Specified according to ICH, Ph Eur and USP
  • Application-oriented quality
  • Reliable and reproducible results 
  • Batch-to-batch consistency

Table 1: SupraSolv® high-purity solvents for headspace GC specify the maximum allowed concentration of every residual solvent defined by the ICH.

Extract of specification
Every residual solvent of class 1 acc. ICH ≤ 1 μg/g
Every residual solvent of class 2 acc. ICH ≤ 10 μg/g
Every residual solvent of class 3 acc. ICH ≤ 50 μg/g

 *ICH = International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use


Pure precision: LiChrosolv® hypergrade solvents for LC-MS
LC-MS , the combination of classical liquid chromatography (LC) with mass spectrometry (MS), is essential in virtually every field of chemical analysis. With its ultra low detection limits and ability to provide valid molecular structure analyses of substances like proteins, peptides or oligonucleotides, the technique is becoming increasingly popular in the pharmaceutical and biotechnical industries. However, solvents play a critical role in the reliability of results since trace impurities could cause background signals and reduce sensitivity.

Merck Millipore’s new generation of LiChrosolv® hypergrade  solvents are specifically produced and accurately tested for LC-MS suitability, and meet all the requirements of modern LC-MS ionization methods. Due to their low level of ionic background and low ion suppression, they excel in reproducibility and ionization efficiency. The solvents’ application-oriented quality also ensures optimum chromatographic results, while avoiding costly analysis repetition and loss of valuable samples. Even the packaging is specially made to suit LC-MS conditions. The extensive range of returnable stainless steel barrels and withdrawal systems are designed for safe and effortless use to avoid the risk of contamination. In every detail, LiChrosolv® hypergrade solvents set new standards for the unlimited application of high performance chromatography.

  • Proven LC-MS suitability
  • Highest batch-to-batch consistency
  • Application-oriented quality
  • High ionization efficiency
  • Excellent baseline clarity


Extract of specification

Suitability for LC-MS
(Bruker esquire 3,000 plus); Intensity of background mass peak based on reserpine:
Mode: ESI 200 μl pos | APCI 200 μl pos  ≤ 2 ppb
Mode: ESI 200 μl neg | APCI 200 μl neg   ≤ 20 ppb
NA (Sodium)   ≤ 100 ppb
K (Potassium)   ≤ 10 ppb

 Filtered by 0.2 μm filter | Suitable for UPLC | UHPLC | Ultra Fast HPLC-instruments

 

© Merck KGaA, Darmstadt, Alemania, 2014


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