Analytical Chemistry
& Trace Analysis

Providing a comprehensive range of Analytical Chemistry services for diverse pharmaceutical applications.

From analytical method development and validation to routine testing and trace impurity analysis, Resolian is your trusted partner for ensuring product safety and quality.

Resolian’s specialists have experience handling all types of formulations, including challenging matrices, such as tablets, capsules, creams and ointments, nasal sprays, oligonucleotides, peptides, and other consumer products.

Reach out to us directly to learn more about Resolian’s Analytical Chemistry & Trace Analysis services.

Analytical Chemistry and Trace Analysis Services in Detail

GMP Method Development, Transfer, and Validation: Resolian’s specialist team designs and optimizes novel test methods, routinely utilizing the chromatography and detection options listed below:

SFC, UPLC, GC and HPLC
MS, MS/MS, QDa, FLD, FID, ECD, VWD and DAD

Forced Degradation and Impurity Profiling: Resolian’s Analytical Chemistry team can help you establish the impurity profile of your compounds via forced degradation studies.

Trace Impurity Testing: Resolian offers expertise in detecting and quantifying trace-level impurities, including Nitrosamines and Genotoxic Impurities.

Batch Release and Stability Study Support: The comprehensive support offered includes protocol development, analysis, and reporting, ensuring product consistency and compliance.

Routine and Pharmacopoeia Testing: Experienced scientists support routine and Pharmacopoeia testing while providing technical support and guidance for analytical challenges.

Appearance and Odor Assessment: Resolian conducts assessments for visible and sub-visible particulates, color, clarity, and odor, allowing assessment of product aesthetics and integrity.

Physico-Chemical Analysis: Capabilities cover pH measurements, selective ion content (e.g., fluoride), pKa/Ka determination, partition coefficient, viscosity analysis, moisture content assessment, and solubility studies.

CASE STUDY:

Determination of
Highly Polar Impurities in Drug Products

A suitable HPLC-UV method for the determination of Impurity X in Drug Product was required.

Impurity X has been seen growing on stability in the Drug Product.
The existing method proved insufficient in resolving Impurity X and any other potential early eluting compounds from the solvent front.

CHALLENGE

Impurity X is a very polar compound with poor retention which elutes at the solvent front (refer to Figure 1).
The goal was to develop a method capable of resolving Impurity X and any other potential early eluting compounds from the solvent front and other components (refer to Figure 2).

RESOLIAN APPROACH

Method Evaluation
Method Development
Method Optimization
Method Validation

SOLUTION

Resolian successfully developed, optimised and validated a GMP method to determine Impurity X using extensive knowledge of method development.

Ready to Solve Your Analytical Chemistry Challenges?

Don’t let inadequate analytical methods compromise your product development timeline or regulatory strategy.

Contact Resolian today to discuss how our analytical sciences team can provide the expertise and solutions you need.

Analytical Chemistry
& Trace Analysis