Analyses
Physical and Chemical Analyses
Laboratory Ofichem is specialised in carrying out physical and chemical analyses of a wide range of pharmaceutical raw materials and pharmacy (stock) preparations.
Analyses - In-house and External
In addition to analyses of pharmaceutical raw materials such as APIs and excipients, Laboratory Ofichem offers expertise to external parties, such as carrying out tests daily (compounding) for pharmacies and hospitals and analysing various medical products such as creams, powders, tablets and herbal products. Analytical methods are also developed and validated for new and existing products.
STATE-OF-THE-ART LABORATORIES
Quality control of pharmaceutical products is an important part of Laboratory Ofichem’s activities. We have state-of-the-art laboratories, and our staff has in-depth knowledge of all existing practices. As a result, we work according to GMP, ICH and ISO guidelines. Our motto is “To build knowledge and continuous improvement, which keeps us ahead of the regulations.”
In our laboratory, we carry out analyses in accordance with pharmacopoeia (EP/USP/BP, etc.) or company specifications.
The analysis methods within Laboratory Ofichem are developed, optimised, verified (compendial) and/or validated (in-house) in accordance with applicable ICH guidelines.
Analysis Possibilities
Laboratory Ofichem can perform multiple analysis techniques, such as:
- Identity Testing
- Chemical testing (pH / density / conductivity etc)
- Optical rotation
- Residual solvents (HPLC/GC)
- Assay and related substances (HPLC/GC)
- Impurity identification
- Water content (KF)
- Limits of detection (LOD)
- Particle size distribution (Laser diffraction/sieve method)
Stability Studies
Laboratory Ofichem has several stability cabinets at its disposal, which are suitable for carrying out stability studies in accordance with the current ICH guidelines. Would you be interested in having stability studies carried out? Then please contact Laboratory Ofichem.
- We have stability cabinets available with the following conditions:
- 40°C / 75% RH
- 30°C / 65% RH
