Institut Kuhlmann - Analytical Services for Pharmaceutical Quality Control

Institut Kuhlmann was founded in 1970 as an independent contract laboratory. The high qualifications of our experts are crucial in enabling us to capitalize on the potential of modern high-tech analytical services for pharmaceutical quality control.

We address customer-specific analytical questions using sophisticated analytical methodology. In the process, we constantly develop and validate new analytical services for pharmaceutical quality control, or adapt existing methods to meet specific customers’ requirements. Institut Kuhlmann operates in full compliance with GMP requirements, is GLP and ISO 17 025 certified and has a license for the analysis of narcotic drugs.

We are your competent contact for all enquiries in services for chemical and pharmaceutical quality control - for routine analyses as well as challenging research projects.

Our analytical services for pharmaceutical quality control include:

• Development and validation of analytical methods for testing of identity, purity, content and stability of pharmaceuticals
• Amino acid analysis: purity and identity of oligopeptides, and quantitative analysis of free amino acids
• Identification of unknown impurities
• Analysis of vitamins, minerals and trace elements
• Shelf life testing of pharmaceuticals under ICH conditions during stability studies

Amino acid analysis

Free or hydrolytically released amino acid analysis using an amino acid analyser is a complex procedure requiring long experience in analytical practice. We are one of the few laboratories applying amino acid analysis as regulated by the European Pharmacopoeia.

The determination of free amino acids in infusion solutions as well as the proof of purity and identity of synthetic oligopeptides after hydrolysis is amongst the amino acid analysis routinely performed in our laboratory.

Vitamins and mineral compounds analysis

Vitamins and mineral compounds are employed in high doses or non-oral pharmaceutical forms for therapeutical purposes. We use HPLC-DAD/RI/FLD, HPLC-MS and HPLC-MS-MS (state-of-the-art methods) for vitamins and mineral compounds analysis.

Water-soluble vitamins we analyse include:

• Vitamin B1, B2, B6, B12, C
• Biotin, niacin
• Pantothenic acid

We also analyse fat-soluble vitamins:

• Vitamin A, E, D3, K1/2/3
• ß-carotene
• Carotinoids

Vitamin-like compounds are also amongst our analysis capabilities:

• Choline, carnitine
• Inositol
• Coenzyme Q10

For trace element and mineral compound analysis, we primarily use inductively coupled plasma mass spectrometry (ICP-MS).

Structure elucidation of unknown impurities

The identification of impurities requires sophisticated analytical techniques and experienced know-how. We offer the complete structural elucidation of unknown impurities by using up-to-date analytical instrumentation and a multi-step approach:

• Isolation and clean-up by using an analytical fraction collector
• Elucidation of the molecular mass and empirical formula by high resolution Fourier transformation mass spectrometry with a mass resolution of <1mmu
• Structure determination by nano-flow NMR in combination with a 1.5µl 1H/13C-detection cell for even small sample amounts

Analytical instrumentation

We supply a wide range of analytical instrumentation. Rapid resolution HPLC systems (Agilent 1200 Series) equipped with DAD and FLD detectors in combination with the most recent column technology (1.8µm particles) provide unsurpassed resolution. In combination with an analytical fraction collector unknown impurities can be isolated.

The HPLC-Triple Quadrupole-MS system (Agilent 6410) is equipped with ESI/APCI ion sources for quantification of active ingredients in complex matrices and sub-ppb concentrations.

Other analytical instrumentation includes:

• HPLC-Single Quadrupole-MS system (Agilent Series 6130)
• Amino acid analyzer (Sykam S 433) for the determination of free amino acids and the composition of (oligo)peptides
• GC-MS systems (Agilent GC/MSD 5973) equipped with EI and PCI/NCI ion sources, FID detector and headspace sampler
• ICP-MS system (Agilent 7500ce Series) with octopole reaction system (interference removal) for the determination of trace elements in pharmaceutical products
• Climatic exposure test cabinets (Binder KBF 720) for shelf life testing according to ICH regulations