Every molecule takes a different analytical journey. Small molecules typically require precise sample preparation and efficient chromatographic separations, while large molecules such as proteins, peptides, and oligonucleotides require specialized techniques to preserve molecular structure and resolve complex variants. The differences in molecular size, structure, and properties directly influence how each molecule is prepared, separated, and analyzed.
Follow the molecule through its analytical workflow with solutions designed to support every stage of analysis. From sample preparation, solvents, and HPLC and GC columns for small molecules to specialized solutions for large molecules, access the products, expertise, and resources needed to select the right approach, develop methods, and achieve reliable, confident results.
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Early discovery workflows require a combination of compound synthesis, sample preparation, extraction, and in vitro assessment to generate reliable data on candidate compounds. SPE and HybridSPE® support selective extraction, cleanup, and enrichment of analytes from complex matrices, while chemical synthesis reagents enable compound generation, reaction development, and lead optimization. ADME/Tox in vitro systems provide data on absorption, distribution, metabolism, excretion, and toxicity, including metabolic stability, permeability, and cytotoxicity. SPME and BioSPME technologies provide direct extraction and concentration of analytes from complex biological samples with minimal sample preparation.
Characterizing an API and establishing its impurity and degradation profile requires appropriate separation, identification, and quantification strategies. HPLC and LC-MS columns support the development of methods to resolve APIs from process-related impurities, degradation products, and other related substances, while impurity and degradation reference standards enable confident identification and accurate quantification. Sample preparation solutions, including online SPE, provide selective cleanup and enrichment for complex matrices and trace-level analysis, while TLC/HPTLC offers complementary approaches for identity, purity, and impurity profiling. Certified reference materials support calibration and quantitative measurements, helping demonstrate the accuracy and reliability of analytical methods.
Analytical quality assurance relies on controlled reagents, high-purity solvents, compliant chromatographic materials, and reference materials to maintain the accuracy and consistency of pharmaceutical testing. HPLC and GC columns, along with HPLC-grade solvents, support reliable chromatographic separations, while titration reagents and dissolution filters are used in quantitative and dosage-form testing. TLC plates support identification and purity testing, and certified reference materials, including ICH Q3D elemental impurity mixes, provide traceable standards for calibration and quantitative analysis.
- HPLC columns (USP/EP/ICH compliant)
- LiChrosolv® solvents
- OmniSolv® solvents (only in the US and Canada)
- HPLC/LC MS grade solvents
- Bio-based HPLC and LC-MS-grade
- Aquastar® KF and Titripur® titration
- GC columns, residual solvents (ICH Q3C)
- TLC Silica Gel 60 G (Ph. Eur.)
- TraceCERT® ICH Q3D elemental mixes
- Millex® filters: dissolution (USP <711>)
- Certified reference materials
Characterizing critical quality attributes requires sensitive and selective analytical methods to detect and quantify potentially genotoxic impurities and other trace-level components. Certified NDMA, NDEA, NMBA, NIPEA, and NDBA standards support accurate identification and quantification, while LC-MS/MS and GC-MS methods provide complementary approaches for nonvolatile and volatile nitrosamine analysis. HybridSPE® enables selective cleanup of complex matrices, and ICH M7/FDA/EMA-compliant methodologies support risk-based assessment of DNA-reactive impurities.
Related resources
Sample preparation
- Brochure: Solid Phase Extration Products
Explore SPE products for selective sample preparation, cleanup, trace enrichment, purification, and matrix exchange across diverse analytical applications.
- Flyer: Supel™ Swift HLB - DPX Tips
Discover Supel™ Swift HLB-DPX Tips for rapid, automated SPE with high extraction efficiency and minimal solvent use across biological, food, and environmental samples.
- Flyer: DPX HybridSPE® Tips
DPX® Tips for automated SPE with HybridSPE® technology, enabling rapid phospholipid removal from biological samples for LC-MS/MS analysis.
HPLC columns
- Brochure: HPLC Column Selection Guide
HPLC columns guide for column selection, chromatography fundamentals, and solutions for reliable HPLC and UHPLC separations across applications.
- Brochure: Ascentis® Express Columns
Explore Ascentis® Express HPLC columns featuring superficially porous particles for fast, efficient separations with high resolution and reduced backpressure.
- Brochure: Chromolith® HPLC Columns
Explore Chromolith® HPLC columns with monolithic silica technology for fast, efficient separations, low backpressure, and high performance in HPLC applications.
- Brochure: Chiral HPLC Columns
HPLC columns for reliable enantiomeric separations, with a range of stationary phases for efficient chiral compound analysis.
- Flyer: Purospher® STAR RP-18 endcapped, 2 μm Capillary Columns
Best in Class C18 phase for excellent peak symmetry, performance and pH stability.
- Ascentis® Express 160Å ZIC®-cHILIC
Columns offering effective retention and separation of polar and hydrophilic compounds, delivering robust chromatography with high selectivity and reproducibility.
GC columns
- GC Columns Selection Guide
Explore the GC Column Selection Guide for choosing the right capillary GC column, stationary phase, and dimensions for reliable separations.
Reference materials
- Flyer: Primary Reference Standards
Primary standards for accurate, reliable analytical measurements, with high-purity standards designed for calibration, method development, and validation.
- Brochure: Quantitative NMR Excellence
TraceCERT® qNMR certified reference materials support accurate quantitative NMR analysis, with high-purity standards for reliable calibration and validation.
- Brochure: Achieve Calibration Excellence
Aquastar® and Certipur® CRMs support accurate calibration for Karl Fischer titration, pH, volumetric, conductivity, AAS, ICP, and IC analysis.
- Brochure: Physical & Chemical Property Standards for Analytical Characterization
Physical and chemical property standards for accurate calibration of instruments measuring pH, density, viscosity, conductivity, color, and more.
- Brochure: Buffer Calibration Standards for pH Measurements
Certipur® pH calibration buffers provide accurate, traceable standards for reliable pH measurements, with ready-to-use solutions and convenient formats.
- Flyer: ICHQ3D
Critical ICH Q3D guidelines for managing elemental impurities in pharmaceuticals, highlighting the importance of certified reference materials to ensure product safety and compliance in the drug development process.
- Brochure: Pharmaceutical Secondary Standards
Pharmaceutical secondary CRMs offer traceable, certified standards for quality control, providing a convenient alternative to preparing in-house working standards.
Reduction and alkylation are key sample preparation steps for protein characterization, where disulfide bonds are reduced to unfold proteins and expose cysteine residues for subsequent modification. TCEP is used as a reducing agent to cleave disulfide bonds, while iodoacetamide alkylates the resulting free cysteine residues, preventing disulfide bond reformation and stabilizing the reduced protein for downstream analysis.
Proteolytic digestion converts intact proteins into peptides with defined cleavage patterns, making them suitable for detailed characterization by LC-MS/MS. Trypsin and Solu-Trypsin provide consistent and reproducible digestion, supporting peptide mapping, sequence confirmation, and identification of protein modifications.
Chromatographic techniques provide complementary approaches for large-molecule characterization based on size, charge, hydrophobicity, affinity, and polarity. SEC supports aggregate and fragment analysis, ion exchange separates charge variants, and reversed-phase chromatography enables impurity analysis. HIC supports drug-to-antibody ratio determination, while affinity chromatography and HILIC are used for selective capture and analysis of impurities such as glycans.
- Size exclusion chromatography (SEC): For aggregate and fragment analysis
- Ion exchange chromatography (IEC): For charge variant analysis
- Reversed-phase chromatography (RPC): For impurity analysis under denaturing conditions
- Hydrophobic interaction chromatography (HIC): For drug-to-antibody (DAR) determination and RPC-like separations under native conditions
- Affinity chromatography: For analyte-specific capture and release
- Hydrophilic interaction liquid chromatography (HILIC): For polar impurity (ex. Glycans) analysis
Protein labeling and mass spectrometry workflows require well-characterized standards and peptides to support reliable protein identification, characterization, and quantitative analysis. SILu™MAb standards provide defined materials for method development and instrument performance assessment, with SILu™MAb Glycan, ADC Mimic, SigmaMAb, and SILu™Prot extending these applications to glycan, antibody, and biotherapeutic characterization. These workflows are further supported by MSQC1, Aqua Peptides, and MSRT standards for mass spectrometry quality control, calibration, and retention-time assessment.
Related resources
Sample preparation
- Poster: Millex® Wall Chart
Select filters by membrane, pore size, diameter, application, and format for reliable sample filtration.
HPLC columns
- Brochure: HPLC Column Selection Guide
Explore the HPLC columns guide for column selection, chromatography fundamentals, and solutions for reliable HPLC and UHPLC separations across applications.
- Brochure: BIOshell™ Columns
BIOshell™ U/HPLC columns with Fused-Core® technology deliver fast, high-resolution separations of proteins, peptides, glycans, and other biomolecules.
- Flyer: BIOshell™ A120 (2.7 μm) Oligo C18 INERTProve™ HPLC Columns: from 1.5 mm I.D. to 4.6 mm I.D.
BIOshell™ A120 Oligo C18 INERTProve™ columns provide fast, high-resolution oligonucleotide separations with high pH and temperature stability.
- Brochure: Chromolith® Monolithic Silica HPLC Columns
Based on monolithic silica technology, these columns provide fast, efficient separations with low backpressure and high performance across applications.
- Brochure: Biopharma Analysis Guide
Analytical solutions for proteins, peptides, mAbs, and other biopharmaceuticals, covering sample preparation, separation, characterization, and analysis.
Reference materials
- Brochure: Biopharma Analysis Guide
Analytical solutions for proteins, peptides, mAbs, and other biopharmaceuticals, covering sample preparation, separation, characterization, and analysis.