We use multiple instruments, including ICP-OES, ICP-MS, and flame and graphite AAS with hydride generation, along with closed vessel microwave digestion and HF capabilities. This range of technology allows us to address a wide variety of sample types and complex matrices, including overcoming physical, chemical, spectral, isobaric and polyatomic interferences.
New, more specific instrumental methods for testing elemental impurities in pharmaceutical products have introduced more stringent requirements from regulatory authorities. Raw material vendors and pharmaceutical companies must implement sensitive technology and robust processes to meet EP, USP and ICH Q3D requirements, while also managing related process impurities that can affect product safety.
We provide full method development, validation and routine testing for elemental impurities, supported by cGMP documentation. Our expert personnel and state-of-the-art laboratories help you meet these requirements with confidence, alongside testing for process-related impurities in biopharmaceutical products.
Why choose elemental impurities testing from SGS?
- Navigate the full testing process
We guide you from identifying which elements to test through to determining limits.
- Determine the right testing approach
We help establish whether you need quantitative or qualitative testing, and whether to test your API or finished product.
- Manage regulatory requirements
We help you understand and address the requirements set out in EP, USP and ICH Q3D.
- Define impurities and limits
We help you establish the required elements and limits for your testing program.
- Apply a tailored testing approach
We screen for elemental impurities through a fully validated or risk-based method.
- Strengthen your risk assessment
We help you build a solid risk assessment wherever additional data is required.
Our impurity testing services
- Elemental impurities testing
We provide method development, validation and routine testing for elemental impurities in raw materials, excipients, APIs and finished products, aligned with EP, USP and ICH Q3D.
- Process-related impurities and residual analysis
We test and analyze process-related impurities in biopharmaceutical products, including host cell protein and host cell DNA detection, to help confirm effective removal by the downstream process and absence from the final product.
Why SGS?
As the world's leading testing, inspection and certification company, we provide the professional expertise, regulatory qualifications and state-of-the-art laboratories to support your elemental and process-related impurity testing needs, from method development and validation to routine testing under cGMP documentation.
We offer multiple locations across Europe, Asia and North America, a wide range of instrumentation including ICP-OES, ICP-MS, AAS and chromatography and mass spectrometry systems, and long-standing experience developing and validating methods across complex sample matrices.
FAQs
We validate our methods either as a limit test or through full ICH Q2(R1) validation, performed under GMP. This is supported by state-of-the-art chromatography and mass spectrometry instrumentation and extensive method development experience.
Yes. We can assist if you are combining your drug products and need your specifications to be set over a range for addition-type testing.
238 TRR Tower, 19th-21st Floor, Naradhiwas Rajanagarindra Road,
Chong Nonsi, Yannawa, 10120,
Bangkok, Thailand