Process Related Impurities

Detect, quantitate and monitor impurities and residuals

Process Related Impurities and Residuals

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What are Process Related Impurities?

Spotlight Interview with CEO and Dr, Andrew J: Why Mass Spectrometry is Such A Powerful Tool!

Analysis of Impurities

Impurity Analysis at BioPharmaSpec

Inducer Sugars (Arabinose, Isopropyl-β-D-thiogalactopyranoside (IPTG)) GC-MS 100ppb
Cell culture antibiotic Streptomycin
Kanamycin
Erythromycin
LC-MS/MS 10ppb
Stabilizer Sugars GC-MS 100ppb
Stabilizer Antioxidants (various acids, Irganox and Irgafos) HPLC-ELSD, GC-MS 100ppb
Stabilizer Amino Acids Derivatization LC fluorescence 1ppm
Solubilizer Surfactants (Tween, Polysorbate, Triton, Tri-n-butyl phosphate (TnBP) ) HPLC-ELSD
LC-MS/MS
GC-MS
10ppb
Solubilizer Denaturants (Guanidine, Urea) Derivatization LC fluorescence 1ppm
Solubilizer Amino acids Derivatization LC fluorescence 1ppm
Buffering capacity Amino acids Derivatization LC fluorescence 1ppm
Tonicity modifier Reduced sugars GC-MS 100ppb
Reducing agents Glutathione, DTT etc LC-MS/MS 10ppb
Chelating agents EDTA GC-MS 1ppm
Antifoam agents and processing additives PEG, PPG and Polydimethylsiloxane (PDMS) containing HPLC-ELSD
LC-MS/MS
10ppb
Free PEG in a PEGylated protein product PEG HPLC-ELSD
LC-MS/MS
10ppb
Anti-flocculation agents pDADMAC LC-MS/MS 100ppb
Impurities unique to specific production processes Tri-n-butyl phosphate (TnBP)  GC-MS 1ppm
Impurities unique to specific production processes Methotrexate LC-MS/MS 10ppb

Customized Process Impurities Services