Analytics

Our Analytical Services

BioChem´s analytical laboratory offers:

  • quality control release testing
  • EU reanalysis
  • stability testing and storage
  • photostability testing
  • analytical method
    • development
    • optimization
    • validation
  • cleaning validation
  • elemental analysis
  • physico-chemical analysis
  • electrochemistry and titration
  • dissolution testing (paddle/basket)
  • water analysis
  • particle testing
  • spectroscopic testing
  • microscopic analysis
  • registration support / expert opinion

for all pharmaceutical

  • finished dosage forms
  • intermediates
  • excipients
  • raw materials

as well as

  • chemical
  • medical
  • cosmetic products

including

  • cytostatics
  • narcotics

Analytical Instruments and Technologies

As a full service provider BioChem has a broad range of high-tech analytical instruments and technologies established including:

  • chromatography
    • HPLC (UV-VIS-D, DAD, FD, RID, ELSD)
    • GC – direct/headspace (FID, WLD, ECD, PND)
    • TLC
    • IC (Anion, Kation)
  • AAS
    • graphite tube, flame, cold vapor , hydrid
    • microwave, high pressure and acid digestion
  • UV-VIS- / FT-IR-spectroscopy
  • microscopy with video documentation
  • electrochemistry and titration
  • particle testing (visible / non-visible)
  • dissolution testing (paddle / basket)
  • water analysis (TOC, conductivity, etc.)
  • physico-chemical analysis
    • osmometry
    • disintegration
    • hardness
    • surface tension
    • etc.

No matter if you are interested in standard routine pharmacopoeial testing or looking for a partner who develops, optimizes and validates your method for identity, content (assay), purity, impurity, related substances or residuals testing our recognized experts are at your disposal.

We constantly establish new technologies and frequently bring our analytical equipment up to date. Please contact us if the technology you require is not listed above.

Stability Testing

We offer all kind of stability studies (longterm, intermediate, accelerated, ongoing, inuse and follow-up) according to ICH including stress- and photostability testing.

Storage chambers are computer-monitored and a 24/7 alarm system is in place:

  • 25°C / 60% r. h.
  • 30°C / 65% r. F
  • 30°C / 75% r. F
  • 40°C / 75% r. F.
  • refrigeration (2-8°C) and freezer (≤-18°C)
  • special climatic conditions(e.g. 25°C/40% r. h.) on request

Outsourcing potential

Since BioChem concentrates to keep a multitude of physico-chemical, elemental or chromatographic techniques and procedures in-house, your advantage in using our services is obvious.

Method development from scratch and optimization including validation or verification according to current GMP guidelines are some of our strengths.

BioChem also supports you in your cleaning validation activities.

Dissolution

BioChem uses apparatus 1 (basket) and apparatus 2 (paddle) according to Ph. Eur./USP for single point dissolution during QC-release testing, 1-tier-/2-tier-dissolution and dissolution curve profiling applying f2-calculation in all kinds of common media including surfactants or enzymes.