Tanja Schötz, Quality Control
We rely on fast
analysis methods.
Our rapid analysis methods are three to four times faster than those of other providers.
Tanja Schötz, Quality Control
QUALITY CONTROL OF
ACTIVE PHARMACEUTICAL
INGREDIENTS
ACTIVE PHARMACEUTICAL
INGREDIENTS
We support our
three production teams
with on-time analytics
Each team has 10 to 14 lab technicians
and adheres to current GMP guidelines.
Inspecting and approving
raw materials
We inspect all materials
purchased from suppliers.
Testing intermediate
stages of synthesis
We check each individual step.
Approving the finished API is
part of our quality
control process.
Testing the stability of our API
Numerous, comprehensive
stability studies set us
apart from the rest
of the field.
Transferring analytical methods
We transfer our customers’
methods to our laboratories,
validate them and then use
them – providing all services
from a single source.
Tanja Schötz, Quality Control
We rely on fast
And no one has faster
implementation controls.
For instance, we need just two to three minutes for in-process measurements with UPLC. We’re also pretty speedy at gas chromatography, which only takes seven minutes. To put this into perspective, older methods required 35 minutes to produce a comparable analysis.
Sebastian Troidl, Quality Control
Sebastian Troidl, Quality Control
Our equipment
- 2 NMR (400 and 500 MHz)
- 20 HPLC
- 7 UPLC
- 1 UPLC/MS
- 8 GC
- ICP-OES, ICP-MS
- Malvern Mastersizer 2000 and 3000
State-of-the-art equipment
We have no trouble keeping up with international competitors. We approve 4900 batches a year, with over 7000 samples.
We usually calibrate
analytical instruments ourselves and train our employees accordingly.
Our employees
are chemists, chemical engineers and 40 laboratory technicians.
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PRODUCING ACTIVE PHARMACEUTICAL INGREDIENTS
We produce highly potent active pharmaceutical ingredients – from
5 kg to 20 tons.
DEVELOPMENT OF TABLETS AND CAPSULES IN THE HIGH POTENT RANGE
We develop and manufacture products in line with international standards.
ENVIRONMENTAL PROTECTION, OCCUPATIONAL SAFETY AND HEALTH
This is how we protect our colleagues and our environment.