Drug Development Solutions

Impurities and contamination in pharmaceutical materialsThe presence of contaminants or impurities in pharmaceutical and consumer healthcare products may lead to undesirable pharmacological and/or toxicological effects, which in turn may affect the safety, efficacy and quality of the product. Contamination and impurity identification and profiling is therefore critical to the safety, efficacy and quality of a pharmaceutical or consumer healthcare product and is a regulatory requirement.

We are highly experienced in contamination investigations and the accurate quantification of trace levels of organic and inorganic impurities (down to sub-ppb levels) in materials including:

• APIs• Excipients• Intermediates• Metabolites• Formulated products

We have a long standing history in the development and validation of bespoke analytical methods for impurity monitoring in the pharmaceutical and healthcare sectors. We apply cutting edge technology and expert knowledge to support impurity identification by structural elucidation and have world leading contamination and foreign particulate matter capabilities.

Our experience includes supporting a wide range of products at the discovery, development and manufacturing stage with the following typical work packages:

Discovery/Development• Reaction monitoring, impurity profiling, impurity method

development

Characterisation• Defining impurities as Critical Quality Attributes, impurity

method validation• Forced degradation/stability• Product related impurities

Safety• Extractable and leachables• Foreign particulate matter (counting and characterisation)• Genotoxic Impurities e.g. N-nitrosodimethylamine (NDMA)• Process related impurities e.g. surfactants, catalyst

residues• ICH Q3D elemental impurities• Residual solvents

Quality• Troubleshooting - unknown ID and structural elucidation• Quality control testing and batch release

These services are delivered from our CMC pharmaceutical analysis facilities which have been inspected by the UK MHRA for cGMP compliance.

Science for a safer world

lgcgroup.com/ddsRegistered OfficeLGC, Queens Road, Teddington,Middlesex, TW11 0LY

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Equipment

Organic analysis• HPLC and UPLC with PDA, MS, UV• GC and Headspace GC with FID, ECD, MS

(Agilent 7890B GC with Agilent 5977 MSD)• Waters Acquity H-Class (PDA) with Waters Synapt

G2 Q-TOF MS (with Ion Mobility Separation)• Waters Acquity H-Class (PDA) with Waters Xevo

G2 XS MS• Supercritical fluid chromatography (SFC) with

PDA, MS• TLC, Dissolution, Titration, pH, Conductivity,

Karl Fisher• Bruker AVHD 600 MHz NMR

Inorganic analysis• Inductively Coupled Plasma with Optical Emission

Spectrometry (ICP-OES) - Thermo iCAP7600 Duo• Inductively Coupled Plasma with Mass

Spectrometry (ICP-MS) - Agilent 7700x and Agilent 7900

Contamination and Foreign Particulates• Sample isolation and preparation - ISO14644

Class 5 standard (FS 209 Class 100) laminar flow cabinets minimising sample contamination

• Light obscuration single particle counter - size• Optical microscopy with image analysis - size,

shape, colour• High Resolution Scanning Electron Microscope

with EDX for qualitative elemental analysis• Fourier Transform Infra Red (FT-IR) Spectroscopy

and Microscopy• Image Analysis• X-Ray Diffraction

For more information on how we can assist with your impurities and

contamination in pharmaceutical materials requirements, please contact us:

lgcgroup.com/enquiries

+44(0)1638 720500

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