Methods Development

analytical_3

Apertus offers a complete package of services for your analytical development needs, from early stage research to fully validated methods for release testing.

We provide rapid, customizable, cost-effective results that help you research, design and market your active ingredients, excipients or finished dosage forms.

Analytical Research Services
Service Description
HPLC Method Development Development of LC methods for drug products, API, excipients, fine chemicals, peptides, amino acids, chiral separations. Forced degradation and stability studies (ICH or other) available.
Stability Testing Basic sample storage or storage and testing plans available. Forced degradation studies and impurity identification and synthesis services are also available.
Forced Degradation Stressed samples of drug substance and drug product are critical to demonstrate the specificity of an analytical assay. We offer full or partial studies. Full studies include photodegradation, chemical stress under acid, base and neutral conditions, oxidative stress and high heat/humidity stress.
GC Methods Development Development of GC-MS and FID methods for finished products, intermediates and raw materials for identification and release testing.
MS Fragmentation Studies Multi-stage ionization and fragmentation of analytes for structure confirmation or the elucidation of unknown structures.

Case Study

Project Objective: Alkaloid extract contains unknown impurity at levels above 1%. Identify and reduce impurity.

Description: Extraction of poppy straw had an unknown impurity that was at levels above 1% by HPLC in about 20% of the extracts. Using prep chromatography, LC-MS and NMR, the impurity was isolated and identified. Trend charts showed a correlation to pH and the impurity’s levels in the drug substance.

Outcome: The manufacturing process was modified to remove or lower the levels of the impurity. Isolation and identification led to a relative response factor for HPLC analysis. The failure rate of this step was improved from 20% to 5%.