Laboratory services
We are your partner for pharmaceutical analysis and quality control.
Analytical services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-release analysis, stability testing and structure determination of unknown substances, our core expertise also include risk-based and solution-oriented customer consultation.
More than 45 employees work in our analytical labs, supported by lean management tools, to specifically and efficiently meet the requirements of our clients. Our interdisciplinary teams and professional project management ensure even your complex projects are a success.
HWI is GMP- and FDA-certified and holds a manufacturing authorisation for the release of clinical and market batches.
Consultation
The HWI team works on the basis of current regulatory requirements for human and veterinary medicinal products as well as for substance-based medical devices and drug-device combination products.
We provide support and advice on analytical and associated regulatory matters:
- Review specifications, analytical methods and validation reports according to the latest scientific knowledge and regulatory requirements
- Planning and implementation of analytical method transfers and production validations
- Gap analysis of CTD modules 2.3/3 together with further experts in the HWI group from HWI regulatory services GmbH and HWI development GmbH
Active ingredients, excipients, ready-to-use products, medical devices
We handle the entire spectrum of pharmaceutical dosage forms and have extensive knowledge of the influences of the matrix on the availability and stability of active ingredients.
We test active ingredients and excipients according to the latest monographs of European Pharmacopoeia and USP as well as other pharmacopoeias on request. For new active ingredients and excipients we develop and validate analytical methods to test for content and purity using cutting-edge analytical equipment. Highly potent active ingredients or narcotics can also be tested in our laboratory after prior verification of the situation.
Our laboratory team of more than 45 members of staff has long-standing experience in developing and validating test methods and the use of these methods for different dosage forms in the quality control of medicinal products.
As part of developing test methods we place special attention on sample preparation to make sure this is efficient and robust. Our experience includes the most diverse complex matrices such as semi-solid and prolonged-release formulations.
Our technical equipment, regulatory expertise and strong team enable us to investigate products with chemically defined active ingredients as well as herbal and biotechnologically produced active ingredients.
We are specialised in the analytical testing and quality control of substance-based medical devices and drug-device combination products, and can draw on our extensive experience in various projects over the past few years.
We develop and validate test methods for identity testing, assay, purity testing and the release of active pharmaceutical ingredients in combination products in accordance with national and international guidelines. As part of the quality control of substance-based medical devices and drug-device combination products, we conduct analytical tests for batch release and shelf life according to defined specifications.
We offer physical–chemical characterisation concepts that are individually tailored to your product and perform the relevant extraction studies in our lab. These are for the tests required according to ISO 10993 as part of biocompatibility requirements.
Technical equipment
Gallery of the technical equipment in our labs: HPLC lab, GC lab, mass-spectrometry lab, ASS lab, dissolution lab and isolation lab.
HPLC lab
24 HPLC Alliance systems by Waters
- UV/DAD detection
- fluorescence detection
- refractive index detection
- light scattering detection (ELSD, MALS)
- conductivity detection
- mass selective detection
- pre- or post-column derivatization
HPLC lab
4 UPLC Aquity systems by Waters
- DAD detection, fluorescence detection
- mass selective detection
2 HClass systems by Waters
- DAD detection
GC lab
6 GC systems by Agilent
- flame ionization detection
- mass selective detection
- split/splitless injection
- headspace-inection with heated syringe or transferline system
Mass spectrometry lab
- Triple Quadrupole mass spectrometer (Quattro Micro API Tandem Quadrupole and TQD Triple Quadrupole) for routine analysis, coupled with UPLC/HPLC
- QToF(time of flight) mass spectrometer for structure elucidation through exact molecular mass determination (high-resolution mass spectrometry), coupled with UPLC
- 5975C XL Quadrupol mass spectrometer, coupled with GC
AAS lab
Multi-element analysis with up to 66 elements in the ppm/ppb range using atomic absorption spectroscopy with graphite tube and flame atomizers
- AAS by Perkin Elmer with flame atomization
- AAS by Agilent with flame atomization
- AAS by Agilent with graphite tube atomization
Dissolution lab
- 4 dissolution testers by Sotax, Apparatus 1 und 2 according to Ph.Eur. and USP with manual or automatic sampling
- 2 dissolution testers by Erweka, Apparatus 1 und 2 according to Ph.Eur. and USP with manual sampling
- 1 dissolution tester by Erweka with high-head operating mode, both with or without extraction cell
Further equipment
- HPTLC by CAMAG with autosampler, scanner and visualizer
- titration instruments Titrino 780, Titrino 751 GDD and Titrando 888 by Metrohm with autosampler for content determinations and volumetric or coulometric Karl Fischer titration
- equipment for determination of refractive index, density, pH value, osmolality, disintegration as well as extensive sample preparation equipment
- FTIR
- Next generation impactor NGI for testing dry powder inhalers
Further equipment
- Bioanalyzer 2100
- 2 UV/Vis spectrophotometers
- Particle counting spectrometer with an automated parental sampling system APSS-200 LiquiLAZ E20P
- viscosimetry: rotational viscosimeter by Brookfield and Ubbelohde type capillary viscometer
Chromatographic equipment
for substance isolation and purification:
- preparative HPLC for isolation and purification of reference substances and impurities (mg to g scale)
- medium pressure liquid chromatography (MPLC) isolation and purification of reference substances and impurities (mg scale)
- fast centrifugal partition chromatography (FCPC) as a supplement to classical chromatographic purification techniques
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