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residual solvents solutions

Featured Products

Rxi®-624Sil MS GC Columns
  • Selective and inert—best in class G43 for USP<467>.
  • Mass spec friendly—highest thermal stability of any 624 column.
  • Manufactured for column-to-column reproducibility—well-suited for validated methods.
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USP Residual Solvent Standards
  • USP equivalent standards for the revised USP <467> general chapter—compliance without the cost—compare prices today.
  • The only complete source for USP <467>.
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Headspace Vials & Caps
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For more products and applications for residual solvents analyses,
please use the links to the right.

FEATURED LITERATURE

Residual Solvent Analysis, Complete
Solutions for Residual Solvent Testing
This 12-page reference piece details requirements for successfully implementing the revised USP <467> method (July, 2008). Includes a review of headspace fundamentals, USP <467> revision method details, chromatography for Procedures A, B, and C, and technical tips for optimization. Guidance on fast, effect method development is given, and a detailed retention time index is provided to simplify
column selection. | Download (484kb pdf)
Custom Residual Solvents Mixes Order Form
Save time and money—let Restek custom blend reference standards specifically for your residual solvent testing needs! | Download (76kb pdf)

FEATURED APPLICATIONS

Improve Pass Rates for Residual Solvents by USP <467> Using the new Rxi®-624Sil MS GC Column
Not all G43 columns are equivalent. New Rxi®-624Sil MS columns reliably produce improved resolution and sensitivity, increasing system suitability pass rates and ensuring more productive laboratory time.
Find out more
Revised USP <467> Residual Solvent Method
USP <467> (general chapter on residual solvent analysis) was recently revised to mirror ICH guidelines. This revision replaces all previous methods. We provide an overview, chromatograms, and technical tips for successfully running the new method. | Find out more
Simplifying Column Selection for ICH Residual Solvents:
Using a Retention Time Index for fast and accurate OVI Separations
To make column selection for residual solvents easy, Restek has benchmarked the ICH Class 1, 2 and 3 residual solvents on our most popular OVI columns.
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8-Minute GC Analysis of Residual Solvents Using an Rtx®-624 (G43) / Rtx®-WAX (G16) Column Pair
Single-injection, dual-column analysis is feasible for residual solvents in pharmaceutical products. Using a Restek G43/G16 column pair and a Gerstel MACH column heating system, we analyzed and confirmed 23 Class 2 solvents in 8 minutes. | Find out more
Tech Tip - Choosing the Correct Liner for Headspace Injections:
Pass System Suitability Requirements with a Smaller Bore Liner
For headspace applications involving a transfer line, a smaller bore liner (preferably 1 mm) can improve system suitability pass rates. This lower liner volume decreases band broadening and allows quicker sample transfer by increasing the linear velocity through the inlet. | Find out more
A Technical Guide for Static Headspace Analysis (PDF)
Static headspace analysis will save you time and money when assaying a variety of sample matrices—and often is easier than alternative sampling approaches. This 20-page guide discusses basic principles, instrumentation, applications, and troubleshooting. | Find out more
Other Articles of Pharmaceutical Interest
Peruse our library of technical articles focused on chromatography applications in the pharmaceutical industry. Relevant to method development, validation, and routine analysis. | Find out more