As a GMP-certified laboratory, we offer physical-chemical contract analyses for our clients from the pharmaceutical, chemical, medical, diagnostic and cosmetic industries. Our portfolio includes a very broad range of physical-chemical analyses to prove the product quality of our clients .
Within our analytical department, we support you with our analyses through all phases of the life cycle management of your raw materials and pharmaceutical products: from the first pharmaceutical developments within clinical studies phase I, II, III and IV or comparative studies of generic drug development, registration as well as routine quality control up to launch and market release.
To ensure the quality of your pharmaceutical products, we test according to the current pharmacopoeias, such as Ph. Eur., USP, JP and further pharmacopoeias on request.
We are pleased to prepare project-based individual offers that consider the desired procedure, matrix and deadline.
List of services: analytical department
Thin layer chromatography (TLC)
- Including photographic documentation
- TLC identity testing
- TLC purity testing (semi-quantitative), limit testing
- Application of special spray reagents
- TLC content determination
High performance liquid chromatography (HPLC/UHPLC)
- Detection: UV-VIS, diode array detector (DAD), refractive index (RI), fluorescence detector und light scattering detector (ELSD), mass spectrometry (MS)
- (U)HPLC identity testing
- (U)HPLC identity/content testing
- (U)HPLC purity testing/related substances
Ion chromatography (IC)
- Conductivity detection; anions/cations with/without suppressor technology, amperometric detection
- IC identity testing
- IC identity/content testing
- IC purity testing
Capillary gas chromatography (GC)
- Detection: flame ionization detection (FID), electron capture detection (ECD), phosphorus nitrogen detection (PND), thermal conductivity detection (WLD or TCD), mass spectrometry (MS)
- Carrier gases: helium, hydrogen. Make-up gases: helium, nitrogen
- Sample feeding systems liquid: autosampler or manual
- Sample feeding system gaseous: headspace
- GC content testing
- GC limit testing
- GC testing for related substances
- GC testing for residual solvents
- GC fatty acid composition
- GC ethylene oxide (EO)/dioxane determination
- GC ethylene oxide (EO)/ethylene chlorohydrin (ECH)/ethylene glycol (EG) determination
- Determination of gas composition/residual oxygen content in the gas chamber of vials, ampoules and prefilled syringes
Special chromatographic methods
- Chromatographic enantiomer separation
- UV/VIS identity testing
- UV/VIS content testing
Infrared spectroscopy (FT-IR)
- Measurement: liquid or solid/KBr pellet or via ATR
- FT-IR identity testing: KBr pellet
- Measurement by automatic laboratory refractometer ATR
- FT-IR quantitative
Atomic absorption spectroscopy (AAS)
- AAS flame, graphite furnace or cold steam/hydride technology
Inductive coupled plasma mass spectrometry (ICP-MS)
- qualitative and quantitative determination
- identity, content, purity and residue testing
- pH value (potentiometric)
- Ions with selective electrode
- Conductometry (conductivity)
- Titration (visual endpoint determination)
- Titration (potentiometric)
- Water content acc. to Karl Fischer (volumetric)
- Polarimetry, specific rotation at 589 nm
- Refractometry, refractive index at 20 °C
- Gravimetry to constant weight (e.g. loss on drying)
- Density by densimeter (oscillation measurement)
- Density by pycnometer – liquids
- Melting point/solidification range
- Boiling point
- Viscosity acc. to Ubbelohde
- Viscosity by rotational viscometer (spindle)
- Surface tension
- Osmolality (by freezing point reduction)
- Osmolality (by vapour pressure osmometer)
- Consistency (micro-penetrometer)
- Total organic carbon (TOC)
- Total nitrogen (TN)
- Clarity and opalescence of solutions
- Colouring of solutions
- Testing for visible particles
- Testing for non-visible particles
- Measurement by light blockage (method 1)
- Microscopic determination (method 2)
- Method development and method optimisation
- Validation/verification of procedures/product-specific validation acc. to ICH guidelines including test plan and test report in agreement with the client (test scope)
- Method transfer including test plan and test report
BioChem is your experienced partner for all issues regarding stability studies of pharmaceutical products (stress and photostability testing, short- and long-term stability studies, on-going studies acc. to ICH guidelines).
Computer-monitored and alarm-secured climate rooms and climate chambers are available for the storage of samples.
Storage conditions according to ICH guidelines:
- – 20 °C
- 5 °C
- 25 °C/60 % r. h.
- 30 °C/65 % r. h.
- 40 °C/75 % r. h.
Further climatic settings can be offered on request.
In addition, the storage of narcotics is possible. Expenses for storage, logistics and analyses result from the specifications of the test material, the quantities to be stored and the stored study protocols.
The following information is required for the preparation of an individual offer:
- the number of batches
- the volume of test samples
- storage conditions needed
- if already determined: test parameters and testing schedule
- Irradiation acc. to ICH Q 1B
- Stress tests acc. to ICH Q 1A
- Dimensions (n = 10)
- Breaking resistance (n = 10)
- Disintegration time (n = 6)
- Uniformity of mass (n = 20)
- tablets, film-coated tablets
- divided tablets
- hard gelatine capsules
- Uniformity of content by means of photometry, HPLC, titration etc. (n = 10)
- Paddle or rotating basket (n = 6) by means of photometry, HPLC etc.
- Comparative dissolution profiles (f2-test)
Physico-chemical tests acc. to current Ph. Eur.
- Calcium, magnesium
- Non-visible particles
- Oxidable substances
- Acidic or alkaline reacting substances
- Heavy metals
- Evaporation residues
Contact the experts of our analytical department
The experts in our analytical department will be pleased to provide you with advice and support in planning and carrying out analytical tests for your products or projects. We will be pleased to prepare an offer tailored to your current issues.
Please use our contact form for your enquiry.