Services

Advande Labs provide a variety of high-quality analytical testing services to support CMC for Drug Development and Release Testing, including complete Analytical Development, Stability, Extractables and Leachables testing. Advande Labs is a global player in the highly regulated Pharmaceutical, Biopharmaceutical, Nutraceutical and Veterinary industry worldwide.

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Analytical Testing

Advande Labs services comprise two divisions: analytical R&D (non-GMP) and QC (GMP). The QC testing is conducted in compliance with GMP guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

Analytical R&D services

Our team of analytical researchers is focused on developing of new analytical methods, troubleshooting, implementation of new techniques and also the support of our QC Lab.

  • Development of methods for quality testing of process materials, drug substances and dosage forms
  • Full analytical support during development of API synthetic routes and drug formulation
  • Impurity identification, synthesis and reference material certification
  • Optimization of analytical Quality Control procedures to obtain High quality data in a shorter time and at a competitive cost
  • Investigations of anomalies occurring at manufacturing of drug substance and product
  • Development of LC-MS and GC-MS methods for trace analysis (GTIs, Nitrosamines)
  • Investigation of samples from complaint procedures
  • Accelerated stress studies of drug substances and dosage forms
  • Analysis of excipients and drug compositions
  • Extractables & Leachables

QC (GMP) services

Reliable, quick and cost efficient QC testing is crucial for our clients who manufacture the validation, registration or commercial batches or who need ICH stability testing. For them we have our professional team at the Quality Control (QC) Lab.

  • Method validations and method transfers to and from clients
  • Stability studies on drug substances and dosage forms, freeze/thaw, and shipping studies
  • Analyses of highly potent substances
  • Quality control and release testing of substances and drug products for both pharmaceutical and veterinarian market
  • Analytical support of formulation development
  • Analytical support of manufacturing process validation
  • Analytical reports, including Certificates of Analysis
  • Osmometry (Vapor pressure)
  • Flow Cytometry (Luminex)

Stability conditions

  • 5 ± 3 °C
  • 25 ± 2 °C/60 ± 5 % RH
  • 30 ± 2 °C/65 ± 5 % RH, 30 ± 2 °C/75 ± 5 % RH
  • 40 ± 2 °C/75 ± 5 % RH
  • Light exposure according to ICH Q1B

Techniques we use

  • HPLC, UPLC
  • GC, GC-MS, LC-MS
  • UV spectroscopy
  • IR spectroscopy
  • NMR, ICPMS (outsourced, data processed in-house)
  • Dissolution (USP 1 and 2)
  • Titration assay and classical pharmacopeial tests
  • Microbial tests (outsourced)
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