KPPT's complete in-house QC Laboratory is fully equipped with modern analytical instrumentation required for raw material testing, finished product release, and ICH-compliant stability studies for pharmaceutical drug substances and drug products.

Testing is performed to provide our clients with the most rapid turnaround, the most thorough documentation, and the greatest cost-effectiveness possible. Our analytical scientists bring deep expertise in method development and validation across all major dosage form types.

Stability Testing Services

  • Stability testing per FDA and ICH guidelines (ICH Q1A, Q1B, Q1C, Q1D, Q1E)
  • Accelerated stability studies (40°C/75% RH) for shelf-life prediction and formulation screening
  • Long-term real-time stability studies (25°C/60% RH, 30°C/65% RH) for NDA/ANDA support
  • Intermediate stability conditions per ICH guidelines
  • Photostability testing per ICH Q1B
  • Freeze-thaw cycling studies for biologics and parenteral products
  • Shelf-life assessment for drug substances and finished formulations
  • Stability chamber management with qualified temperature and humidity monitoring

Analytical Method Development

  • Stability-indicating analytical method development for drug substances and drug products
  • HPLC and UPLC method development for assay, related substances, and degradation products
  • Dissolution method development and optimization
  • Particle size and morphology analysis
  • Spectroscopic methods (UV/Vis, FTIR, NIR)
  • Karl Fischer moisture determination
  • Microbiological testing methods
  • Physicochemical characterization methods

Analytical Method Validation

KPPT designs and executes full method validation studies per ICH Q2(R1) and FDA guidance for industry. Our validation packages include all required parameters:

Specificity & Selectivity

Demonstrated through forced degradation studies and interference testing to confirm method resolves API from degradants and excipients.

Linearity & Range

Validated across the specification range with statistical analysis of correlation coefficients and residual plots.

Accuracy & Precision

Recovery, repeatability, intermediate precision, and reproducibility demonstrated across multiple analysts and days.

Detection & Quantitation Limits

LOD and LOQ determination for impurity and degradation product methods per signal-to-noise and statistical approaches.

Robustness

Deliberate variation of method parameters to demonstrate reliability under normal operating conditions.

Solution Stability

Demonstration of analyte and standard stability under method conditions to support routine lab operations.

Contract Analytical Testing

KPPT provides contract analytical testing services under cGMP and cGLP conditions, including:

  • Raw material identity and purity testing
  • In-process and release testing of drug substances and drug products
  • Certificate of Analysis generation for batch release
  • Compendial testing per USP, EP, and BP monographs
  • Cleaning validation analytical support
  • Reference standard characterization and qualification

Technology Transfer

1

Method Receipt & Review

Complete review of method documentation, equipment requirements, and reference standards before transfer begins.

2

Qualification Runs

Side-by-side qualification experiments demonstrating equivalence between sending and receiving laboratories per ICH Q10 principles.

3

Documentation Package

Complete method transfer report, updated SOPs, and system suitability criteria ready for regulatory submission.

Regulatory Documentation Support

KPPT provides complete regulatory and documentation support for FDA's CMC sections in:

  • Investigational New Drug (IND) applications
  • New Drug Applications (NDA)
  • Abbreviated New Drug Applications (ANDA)
  • Annual Product Reviews and stability data trending
  • Post-approval change supplements requiring analytical data

Complete In-House QC Laboratory

Unlike many CDMOs that outsource analytical work, KPPT maintains a complete in-house QC laboratory. This means no delays waiting for third-party results, no data transfer risks, and full accountability for the quality of every test result supporting your regulatory submission.