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

Method Validation

Methods are validated according to FDA/ICH/USP guidelines and follow either a specific client protocol or Sipka Labs standard operating procedures. All validation projects can be custom designed to meet a specific set of analytical requirements. A validation report is provided with every validated method.

Methods are written in a format easy to understand, and also to facilitate method transfer. Our scientists are available to answer any questions about a procedure even after the project has been completed. We work very closely with our clients to understand and execute any challenging task and assure on-time delivery of the results.

Value Added Services

Quality Assurance

Sipka Labs ensure accurate, high-quality results the sponsors need through:

  • Thorough review of study data and reports
  • Strict compliance with SOPs and analytical methods

Project Management

The Project Managers are professionals with scientific training, experience, and effective project management and communication skills. We provide customized service to the individual needs of the client and data of the highest quality.

Client Services

Client satisfaction is a high priority at Sipka Labs. We guarantee that each client will have direct access to a single point of contact who is most intimately involved with the client's project from 7:30 AM to 9 PM everyday.