Skip to Content
Merck
CN

Drug Analytics and QC

Reliable biochemicals for analytical testing, impurity profiling, and quality control

HomeIntegrated OfferingsBiochemical applicationsBiochemicals in Drug DevelopmentBiochemicals for Drug Analytics and Quality Control

 

As drug candidates progress toward production, analytical development and quality control become defining activities. Biochemical reagents, including high-purity buffers, metabolic assay tools, and formulation excipients, support impurity profiling, stability testing, and method validation. The biochemicals on this page are selected for use at this critical transition between late-stage development and production readiness.

In late-stage development, analytical method development and quality control depend on biochemicals that deliver consistent, traceable performance. High-purity buffers maintain pH and ionic conditions across stability assays and chromatographic methods. Metabolite libraries and assay kits provide reference points for impurity identification and mechanistic characterization of degradation pathways.

Batch-to-batch consistency depends on well-characterized biochemical reagents performing reliably across analytical runs. Buffer formulations, stabilizers, and reference materials contribute to method ruggedness during scale-up. Our BioUltra and BioXtra grade biochemicals provide the purity and traceability required for comparability studies and documentation prepared for production readiness assessments.

Gloved scientist places a test tube into a blue rack filled with laboratory sample tubes.
Preclinical drug development

Biochemicals for toxicology studies, biomarker analysis, and efficacy testing to support preclinical research.

Three scientists discuss research findings around a laptop in a modern laboratory.
Clinical trials (I-III)

Biochemicals for formulation development, analytical testing, and biomarker studies throughout clinical trials.

Scientist in protective clothing and face mask uses a tablet inside a laboratory cleanroom.
Analytics and quality control

Biochemicals for method validation, impurity analysis, batch testing, and quality control workflows.

 


Related categories

A 3D illustration of a molecular structure featuring interconnected atoms represented by colored spheres, showcasing the complexity of chemical compounds against a blurred background.
Amino Acids

Essential derivatives for metabolomics, protein structure, and biosynthesis research.

View products
Close-up of numerous green spoon heads arranged in tight, orderly rows, creating a patterned effect.
Avanti Research™, A Croda Brand

High-purity lipids and tools for advanced lipidomics research.

View products
Light blue biological buffer solution in beaker with pipette.
Biological Buffers

High-purity formulations in varied packaging for superior solution stability and pH control.

View products
Gloved hand adding white powder to a glass beaker in a laboratory, with colorful flasks and scientific equipment in the background.
Carbohydrates

From cell culture supplements to glycan building blocks – highly pure and research-ready.

View products
Close-up image of colorful circular shapes and bubbles with a vibrant combination of red, yellow, and green hues.
Detergents

Surfactants across all charge types, including REACH-compliant biodegradable alternatives.

View products
Scientist wearing safety goggles examines blue liquid samples in test tubes in a laboratory.
High-Purity Biochemicals and Reagents

BioUltra, BioXtra and BioPerformance — certified grades for contamination-sensitive workflows.

View products
Automated laboratory pipette dispensing liquid into a multiwell plate, with test tubes and colorful samples in the background.
Metabolite libraries

Primary pathway compounds in ready-to-use formats for metabolomics profiling and identification.

View products

Explore our products and services

Person in lab coat with peptide, safety gloves, and safety goggles, working in a lab.
High-Purity Biological Buffers in Production Scale

Discover high-purity biological buffers for production scale. Ensure stability, pH control, and consistent supply with our expert manufacturing solutions.

Explore now