At ALS, our pharmaceutical business provides a wide range of services to the pharmaceutical and healthcare industries. Committed to exceeding client expectations we are able to provide high quality solutions across a range of products, including human and veterinary products, intermediates and raw materials ultimately for release to market or into manufacturing.
With a comprehensive range of tests, qualified analytical equipment and experienced and skilled staff, clients can have confidence in the integrity and quality of test results. Our independent GMP compliant laboratories are inspected by local healthcare regulators with many also being US-FDA inspected. Compendia analysis is supported by a broad range of chemical techniques and analytical equipment, some typical examples detailed further below.
Good Manufacturing Practice (GMP) for Medicinal Products requires batch release against the approved product specification. Our analytical laboratories utilise broad analytical technologies to provide responsive release testing using pharmacopoeia or client specific methods, confirming that products meet their specification. Routinely handling a diverse range of sample matrices leaves ALS well positioned to meet the needs of our clients' ever expanding product portfolios and diverse product ranges.
ALS routinely handle:
ALS support a comprehensive range of compendia testing for raw materials, purified water, chemicals, excipients and intermediates against a range of standards including ACS, BP, EP, JP, USP and FCC. Our raw material testing helps to assure manufacturers in their plight to release materials for use in the manufacture of healthcare products.
ALS naturally supports verification of compendia methods. The verification process for compendia test procedures is the assessment of whether the procedure can be used for its intended purpose, under the actual conditions for raw materials. Requirements are driven by both GMP legislation and USP <1226> - ALS works collaboratively with clients to form appropriate, risk-based approaches to verification where considered a requirement.
|Method / Technique (A-Z)||European Pharmacopoeia Method||U.S. Pharmacopeia Chapter|
|Atomic Absorption Spectrophotometer||Atomic Spectrophotometry: Emission and Absorption (Ph. Eur. method 2.2.22)||USP ⟨852⟩ Atomic Absorption Spectroscopy|
|Auto-titrator||Amperometric, Potentiometric and Voltametric Titrations (Ph. Eur. method 2.2.19)||USP ⟨541⟩ Titrimetry|
|Compendia Limit Tests||Various Methods||Various Methods|
|Complexometric Titrations||Ph. Eur. methods 2.5.11||USP ⟨541⟩ Titrimetry|
|Dissolution Testing (Baskets and Paddles)||Dissolution (Ph. Eur. method 2.9.3)||USP ⟨711⟩ Dissolution|
|Electrical conductivity measurements||Conductivity (Ph. Eur. method 2.2.38)||USP ⟨644⟩ Conductivity of Solutions|
|Endotoxin||Bacterial Endotoxins, Ph. Eur. method 2.6.14||USP ⟨85⟩ Bacterial Endotoxins Test|
|Fluorimetry||Fluorescence Spectrophotometry (Ph. Eur. method 2.2.21)||USP ⟨853⟩ Fluorescence Spectroscopy|
|FTIR (Fourier-transform infrared spectroscopy)||Absorption Spectrophotometry, Infrared, Ph. Eur. method 2.2.24||USP ⟨197⟩ Spectroscopic Identification Tests|
|Gas Chromatography (with various detectors
including FID and headspace)
|Gas Chromatography (Ph. Eur. method 2.2.28)||USP ⟨621⟩ Chromatography|
|High-performance liquid chromatography
(with various detectors)
|Liquid Chromatography (Ph. Eur. method 2.2.29)||USP ⟨621⟩ Chromatography|
|Ion Chromatography||Ph. Eur. method 2.2.29 couple with conductivity detectors and various suppressors||USP ⟨621⟩ Chromatography|
|Karl Fischer Titrator (Volumetric and Colorimetric)||Determination of Water (Ph. Eur. method 2.5.12)||USP ⟨921⟩ Water Determination|
|Osmolality||Ph. Eur. method 2.2.35||USP ⟨785⟩ Osmolality and Osmolarity|
|Ovens||Determination of Loss on Drying (Ph. Eur. method 2.2.32)||USP ⟨731⟩ Loss on Drying|
|pH meters||Determination of pH Values (Ph. Eur. method 2.2.3)||USP ⟨791⟩ pH|
|Polarimeter||Determination of Optical Rotation and Specific Optical Rotation (Ph. Eur. method 2.2.7)||USP ⟨781⟩ Optical Rotation|
|Refractive Index||Determination of Refractive Index (Ph. Eur. method 2.2.6)||USP ⟨831⟩ Refractive Index|
|Relative density||Ph. Eur. method 2.2.5||USP ⟨841⟩ Specific Gravity|
|Thin-layer chromatography (TLC)||Thin-layer Chromatography (Ph. Eur. method 2.2.27)||USP ⟨621⟩ Chromatography|
|Total Organic Carbon Analyser||Total Organic Carbon in Water for Pharmaceutical Use (Ph. Eur. method 2.2.44)||USP ⟨643⟩ Total Organic Carbon|
|UV/VIS spectrophotometer||Ultraviolet and Visible Absorption Spectrophotometry (Ph. Eur. method 2.2.25)||USP ⟨857⟩ Ultraviolet-Visible Spectroscopy|
|Viscometers||Viscosity (Rotating Viscometer Method) (Ph. Eur. method 2.2.10)||USP ⟨912⟩ Viscosity—Rotational Methods|
|Water Activity||Water-Solid Interactions: Determination of Water Activity (Ph. Eur. method 2.9.39)||USP ⟨922⟩ Water Activity|