Method Development & Validations

Method Development & Validations

Method Development
Method Development & Validation Services

Pharmatech-LLC offers in-house method development & validation services based on customer’s needs. Whether you need to implement cross-validation, create a method validation or modify a generic method validation protocol, Pharmatech’s chemists are able to run adequate experiments and generate documents to support existing methods or new test methods. Below are some possible requirements and resources owned by Pharmatech-LLC:

Possible Requirements
  • Assay & Related Substances
  • Stability Indicating Assays
  • Cleaning Procedures
  • Residual Solvents
  • Cross-Methods / Method Transfers
  • Formulation Development & Product De-formulation Support
  • Reference Standard Qualification
  • Vendor Qualification
  • Characterization of reference standard and drug substances
  • Specificity
  • Accuracy / Recovery
  • Precision
  • Sensitivity (LOD & LOQ)
  • Linearity
  • Range
  • Robustness
Resources
  • HPLC assay & Impurity drug substances (API)
  • TLC impurity (quantitative) API
  • GC organic volatile impurity API
  • HPLC assay * impurity drug product (DP)
  • GC preservative/excipient DP
  • UV content uniformity DP
  • HPLC dissolution DP
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