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Residual Solvents Solutions

Residual Solvents Solutions

Rxi®-624Sil MS Columns (fused silica)

(midpolarity Crossbond® silarylene phase; similar to 6% cyanopropylphenyl/94% dimethyl polysiloxane)

  • Low bleed, high thermal stability column—maximum temperatures up to 320 °C.
  • Inert—excellent peak shape for a wide range of compounds.
  • Selective—highly selective for residual solvents, great choice for USP<467>.
  • Manufactured for column-to-column reproducibility—well-suited for validated methods.

    Click here for more information on our Rxi® columns.

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>.

Headspace Vials & Caps

  • 10 and 20mL screw-thread vials available.
  • 18mm magnetic screw-thread caps.
  • Crimp vials and seals also available.

Technical Articles

Pharmaceutical

Revised USP 467 Residual Solvent Method Satisfy New Method Requirements with Restek Columns and Standards

The United States Pharmacopeia recently revised the general chapter on residual solvent analysis, USP <467>, to mirror the International Conference on Harmonization (ICH) guidelines for the identification, control and quantification of residual solvents. This revision, effective July 1, 2007, replaces previous methods that were not consistent with the ICH guidelines. Here we provide an overview, chromatograms, and technical tips for successfully running the new procedure.

Pharmaceutical

Organic Volatile Impurities: Retention Time Index

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.

Pharmaceutical

8-Minute GC Analysis of Residual Solvents Using an Rtx®-624 (G43) / Rtx®-WAX (G16) Column Pair

Single-injection, dual-column detection/confirmation assay is feasible for regulated solvents in pharmaceutical products, but no temperature program provides sufficient resolution on both columns. Using a Restek G43/G16 column pair and independent temperature programs in a Gerstel MACH column heating system, we analyzed and confirmed 23 Class 2 solvents in 8 minutes.

PDF Document

A Technical Guide for Static Headspace Analysis Using GC

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. Restek capillary GC columns and an extensive selection of accessories will simplify getting started. (PDF - 633kB)

PDF Document

Custom Residual Solvents Mixes

Save time and money—let Restek custom blend reference standards specifically for your residual solvent testing needs! (PDF - 76kB)

PDF Document

Residual Solvent Analysis: Implementing USP <467>

This 12-page reference includes a review of headspace fundamentals, the revised USP <467> method (July, 2008), chromatography for Procedures A, B, and C, and technical tips for optimization. Guidance on fast, effect method development is given. (PDF - 471kB)

PDF Document

Rxi®-624Sil MS

Develop impurity methods faster and more efficiently using a single column that combines the selectivity of a 624 with the thermal stability of a 1 or 5 type column. The new Rxi®-624Sil MS column offers good retention of polar compounds, mass spec compatibility, and unsurpassed inertness, making it the most broadly applicable GC column available to the pharmaceutical industry. (PDF - 1058kB)