Analytical testing

Product & raw material quality control testing

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.

Extensive range of analytical methods

Batch / lot release testing

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:

  • Small Molecules
  • Oral Solid Dose (OSD) – Tablets and Capsules
  • Semi-Solids – Creams, Ointments, Gels, Topical, Syrups, Oral Solutions
  • Injectables
  • Ophthalmics
  • Controlled Drugs and Controlled Substances
  • High Potency Products (including oncology and hormones)

 

Raw material testing

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.

  • Active Pharmaceutical Ingredients (API)
  • Colorants
  • Common Chemicals
  • Dietary Supplement Ingredients
  • Essential Oils
  • Excipients
  • Food Additives and E Numbers
  • Herbal Materials & Botanicals
  • Intermediates
  • Purified Waters
  • Reagents
  • Solvents

 

Pharmacopoeia, standards & compendia methodologies include:

  • ACS - American Chemical Society
  • BP - British Pharmacopoeia
  • CL - Czech Pharmacopoeia
  • FCC – Food Chemicals Codex
  • ICH Guidelines
  • JP - Japanese Pharmacopoeia
  • Ph. Eur. - European Pharmacopoeia
  • USP/NF - United States Pharmacopoeia

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.

Analytical method

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