R&D Centerr&d manufacturing sites

Analytical Services


Peace of Mind

Analytical testing constantly assesses the product quality from development to final release.

Our team comprises over 20 analytical experts using regularly maintained, updated, and qualified equipment performing the following services:

  • Analytical Methods Development and Validation
  • Analytical Methods Transfer
  • Storage in ICH and WHO recommended climatic chambers conditions (10 suites with all ICH zones including semi-permeable and light exposure stress conditions)
    • ICH Stability Testing for expiration and holding date/time setting
    • Quality Control for QP Release
  • Extractable and Leachable closure system compatibility studies
  • Unknown substances identification and characterization (Using LC-Mass spectroscopy)

Equipment

  • More than 20 HPLC (Agilent and Waters) equipped with several types of detector such as DAD, refractometer and multi wavelengths detectors
  • 2 UPLC-DAD (screening of analytical methods and Quality Control)
  • 1 H-Class, 1 GC and 1 UPLC/MS coupled system
  • 8 Dissolution testing apparatus SOTAX (on-line UV or HPLC, off-line, flow-through cell USP type IV)
  • IR (FT-IR) detection
  • Karl Fisher, Coulometer, Potentiometer
  • Metered dose inhaler tester

ICH Stability Programs

Qualified ICH climatic chambers equipped with recording systems and security alarms provide:

  • Climatic zones I, II, III, IV
  • Reduced humidity for semi-permeable products
  • Sun-test for photo-stability testing.

Crystal software provides sample handling with 100% traceability of entry and removal of stock.

Storage of products is provided as a stand-alone service, and may or may not include the analysis package. Climate controlled and regular shipping services are available.

ICH Climatic Storage Capacity

ICH climatic chambers

Conditions

Volume in m3

25°C/60% RH

41

25°C/40% RH

23

30°C/65% RH

27

30°C/70% RH

6

30°C/75% RH

16

30°C/35% RH

5

40°C/75% RH

27

40°C/25% RH

3

5°C

2

-20°C

0.5