Pharmaceutical Material Testing is critical to drug development from early-stage through to commercial batch release.
The quality of pharmaceutical materials can vary considerably from supplier to supplier, and even batch to batch, and so controlling the quality of pharmaceutical materials is key to the success of the product.
When you outsource Pharmaceutical Material Testing, you will need to select a partner with a strong history of delivering to a consistently high standard, allowing you to focus on your core business agenda. Our Pharmaceutical Material Testing program covers raw materials, excipients, APIs and finished products. Intertek specializes in Pharmaceutical Material Testing including verification of compendial methods, transfer of your established methods and validation of alternate methods.
In addition to batch release, our experienced analytical scientists are used to trouble shooting quality control issues and can assist you with developing a detailed specification for the material. Method development and validation services compliment pharmacopeial testing services should specialist QC methods be required.
Our well-equipped, state-of-the-art GMP compliant laboratory offers comprehensive Pharmaceutical Material Testing services according to the pharmacopoeia (e.g. USP and EP) and to your specifications. You’ll benefit from our local service, fast turn-around times, and high-quality analytical testing services.
Our comprehensive range of Pharmaceutical Material Testing services is as follows:
Pharmaceutical Products
We offer testing for:
- Raw materials
- Excipients
- Active pharmaceuticals ingredients (API)
- Biopharmaceutical products
- Final product release testing
- In process release testing
- Personal care products
- Medical devices
Chemicals Test Parameters
Our chemicals test parameters include:
- Identification
- Assay: Chromatography and Titration
- Impurities
- Dissolution
- Residual solvents
- Elemental impurities (heavy metals)
- Titration / Water (by Karl-Fisher)
- Uniformity of dosage unit
Physical and Physico-chemical Test Parameters
Our physical and physico-chemical test parameters include:
- Description
- pH
- Conductivity
- Density
- Specific gravity
- Melting point
- Particle size distribution (wet/dry)
- Moisture determination (we still use the term LoD)
- Limit tests
- Hardness
- Friability
- Sulphated ash
- Anions and Cations
- Volatile organic compounds (VOC)
- Specific/Optical rotation
- Organic volatile impurities (OVI)
Pharmaceutical News & Events
- EVENT - Meet us in Berlin - mRNA-Based Therapeutics Summit Europe (27 - 29 Jan 2026)
- PRESS RELEASE: Expansion of capacity with acquisition of new facility in Melbourn, Cambridge
- PRESS RELEASE: Launch of extractables and leachables services for compliance with new Korean Pharmacopeia requirements
- PRESS RELEASE: Intertek partners with CrystecPharma to advance formulation science and accelerate development for dry powder inhalers
- NEW! Blog: Optimising Quality in Pharma Supply Chains
- Determination of Particles in Pharmaceuticals - Article
- Discover our Audit Live Tool for direct access to our scheduled audits
- Extractables/Leachables Lab Tour - Request access
- Medical Device Extractables & Leachables Studies
- Glycosylation Analytical Approaches for Antibody Therapeutics
- Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
Pharmaceutical Laboratories
Intertek Pharmaceutical Services Manchester (UK)
Intertek Melbourn (UK)
Intertek Switzerland Analytical Laboratory (Basel, Switzerland)
Intertek Pharmaceutical Services (Whitehouse, NJ, USA)
GMP and CMC Laboratory Services, India (Mumbai, India)
Resources
- App Note: Determination of Low/Trace Level Benzene in Pharma Excipients and Finished Products
- Webinar: Design of Extractables Leachables Studies
- Article: Nitrosamine Impurity Screening in Drugs
- Webinar: E/L Studies for Process Materials and Container Closure Systems
- Webinar: ID & Quantification of Pharma Impurities
