Pharmaceutical and Chemical Analysis Services

  • Assay, purity, degradation product, excipient compatibility, product stability
  • chemical and manufacturing control (CMC)

Analytical method development for raw materials, drug substances and drug products. Separation optimization for impurity and degradation products. Accelerated stability testing and excipient compatibility studies.

Key Benefits
  • Strong method development expertise
  • Small molecule and protein therapeutics
  • Excel in separation technology
  • Focusing on method robustness and ruggedness
  • Guaranteed method transferability
  • Dedication to customer service

Capabilities

  • Stability-indicating analytical method development
  • Accelerated excipient compatibility screening
  • Accelerated stress studies
  • Degradation product and pathway identification
  • Drug substance and product assay
  • Impurity and degradation product assay
  • Method validation and transfer
  • Chiral separation
  • Ion-pairing chromatography
  • Compendial methods
  • LC/MS/MS methods for pharmaceutical products

Peptide Analysis

Amino Acid Analysis

The amount of eighteen amino acids are determined - the normal 20 amino acids except tryptophan and cysteine. Asparagine is determined as aspartic acid and glutamine as glutamic acid.

We provide
Proteins/peptides are hydrolyzed using gas-phase HCl. The released amino acid residues are analyzed on an reversed phase HPLC after pre-column derivatization or HPLC/MS/MS.

You receive
Results are delivered as a chromatogram and include a table of picomole/amino acid, amount in microgram and calculation of pmol sample based on either number of residues or amino acid sequence (if supplied).

Molecular Weight Determination

Mass spectrometric analysis provides you with the molecular weight (Mw) of your intact protein, peptide or oligonucleotide. You deliver lyophilized or frozen solution sample in microgram scale.

We provide
Your sample is dissolved and micropurified, if necessary, prior to Electrospray mass spectrometric analysis.

You receive
The final report will be delivered as a PDF file containing the MS spectrum and a table of peaks.

Peptide Sequencing using Electrospray tandem Mass spectrometry

This service is based on the MS/MS sequencing procedure. The analysis is applied to pure peptide samples delivered in lyophilized powder.

We provide
Sample solution will be infused into the mass spectrometer. Theoretical fragments (e.g. b-ions and y-ions) will be monitored to verify the amino acid sequence of the peptide. By using a proprietary procedure, maximum number of fragments are generated to ensure the successful verification of the full peptide sequence.

You receive
The final report will be delivered as a PDF file containing the theoretical peak table, verified peak table (b-ion and y-ion), and a discussion on the verification of the sequence.

Water content by Karl Fischer

This service is based on the USP standard KF titration procedure. The analysis is applied to pure peptide samples delivered in lyophilized powder.

We provide
KF titration and quantitation based on comparison to a standard sample.

You receive
Results are delivered as a PDF file containing the Certificate of Analysis of the sample.

Residual Apolar Solvent

This service is based on the USP standard KF titration procedure. The analysis is applied to pure peptide samples delivered in lyophilized powder.

We provide
KF titration and quantitation based on comparison to a standard sample.

You receive
Results are delivered as a PDF file containing the Certificate of Analysis of the sample.


Pharmacokinetics
– LC/MS/MS and Immunoassay Services

Bioanalytical method development and GLP sample testing for pharmacokinetic/toxicokinetic studies.
Key Benefits

  • Strong commitment to GLP compliance
  • Fast turn-around time
  • Exceptional technical excellence
  • Automated laboratory sample and data management system
  • API-4000 LC-MS/MS
  • Dedication to customer service
  • Capabilities
  • Bioanalytical method development
  • Bioanalytical method validation
  • GLP bioanalytical sample analysis
  • Research sample analysis
  • Protein binding
  • PK data analysis and report
  • PK/PD modeling

Drug Metabolism – Metabolite Synthesis

Drug metabolism is an important area for understanding the dispositional fate of drug candidates. Phase I and II metabolism result in chemical modification and conjugation of parent compound. Typically more water soluble metabolites are formed which facilitates the excretion of the drug through renal or biliary excretion routes.
To speed up the drug development process, drug metabolism studies are typically conducted at discovery lead screening stage and more detailed characterization follows when the drug enters clinical trials.

  • In vitro drug metabolism studies
  • Metabolic pathway identification
  • Metabolic synthesis of major drug metabolites (mg to g scale)



To request PKA Bioanalytical Lab service, please: