Services
The Scientists at the Sipka Labs are experienced in developing and validating a variety of cost effective, stability indicative and robust analytical methods for multi-analyte drug products and drug substances. Our staff has experience in developing and validating methods for tablets, capsules, liquids, implants, parenterals, and nasal formulations. Method validations are performed in accordance with the FDA/ICH/USP guidelines or other relevant regulatory guidelines and client SOPs. A partial list of our services includes development and validation of:
- Stability Indicating HPLC methods and Chiral Separations
- Detection modes available include UV/VIS, MS, ELSD, RI, conductivity and fluorescence
- Forced degradation studies
- Method remediation / alternative analytical methods
- Analytical Methods for controlled drug substances and products of schedules II-V
- Cleaning Validation (Specific and Non-specific analysis)
- Residual Solvents and assay for small molecules by Gas Chromatography
- GC/MS Analysis
- Dissolution methods for Immediate release, Modified release and Poorly soluble drug products
- Elemental Analysis
- Impurities Identification and Quantitation by MS & LC/MS
- Quantitative measurement of active drugs and or their metabolites in biological matrices using LS/MS/MS