Quality
Control
At AMSbiopharma, we provide specialized quality control services to ensure the safety and efficacy of pharmaceutical products. From drug impurity analysis to protein and nucleic acid-based biopharmaceutical testing, we use advanced techniques like UPLC-MS/MS and ICP-MS to meet the highest industry standards and regulatory requirements.
Drug impurities
Impurities in drug substances or pharmaceutical products are any chemical substances that are not the Active Pharmaceutical Ingredient (API) or an excipient, and they can impact drug safety and efficacy. Their identification, quantification, and control are critical throughout the drug development process, as they may arise from materials, by-products, degradation, or packaging.
AMSbiopharma specializes in the analysis of nitrosamine impurities, helping clients ensure compliance with regulatory daily intake thresholds for these potential carcinogens. We also offer advanced methods for detecting NDSRIs (Nitrosamines Derived from Ingredient-Related Substances), a growing concern in pharmaceutical safety, ensuring your products meet the highest standards.
Related Services
Identification of uknown drug impurities
UPLC-DAD-HRMS
Isolation of drug impurities
Prep-LC
Quantitation of drug impurities
UPLC-MS/MS and GC-MS/MS
Analysis of nitrosamines
UPLC-MS/MS and GC-MS/MS
Extractables
UPLC-HRMS, GC-MS/MS and ICP-MS
Leachables
UPLC-HRMS, GC-MS/MS and ICP-MS