Skip to content

Elemental Impurities and Trace Metals Analysis

USP<232>/<233> ICH Q3D Elemental Impurities Testing

Elemental impurities can originate from raw materials, catalysts, manufacturing equipment, packaging systems, and environmental contamination. Detecting these contaminants at trace levels requires more than sensitive instrumentation—it requires the right analytical strategy. Matrix effects, sample preparation, contamination control, and regulatory expectations all influence the quality and defensibility of elemental impurity data.

At Quantum Analytics Group, our scientists evaluate the chemistry of your material before selecting the analytical approach that best supports your project—not simply the instrument available. Using advanced ICP-MS and ICP-OES technologies, we develop and apply robust, matrix-specific analytical methods that generate accurate, reproducible data for even the most challenging  product matrices.

Backed by more than 30 years of analytical expertise, we support pharmaceutical, medical device, biotechnology and personal care companies throughout the product lifecycle—from early development and method validation to routine GMP testing, investigations, and commercial manufacturing. Our laboratory provides elemental impurities testing for APIs, finished drug products, excipients, raw materials, biologics, medical devices, cosmetics, and packaging components in support of USP <232>, USP <233>, ICH Q3D, and global regulatory expectations.

 Whether you are qualifying a new material, validating a USP <233> analytical method, investigating unexpected elemental impurities, or preparing data for regulatory submission, Quantum Analytics Group delivers reliable, scientifically defensible results that help you make confident decisions and bring safe, compliant products to market.

REQUEST A QUOTE

Why Partner with Quantum for Elemental Impurities Testing? 

Quantum provides scientifically sound, regulatory-focused elemental impurities testing and consulting to support pharmaceutical development, validation, and commercial manufacturing. Our experts work with you to develop a testing strategy that is appropriate for your product, process, and regulatory requirements.

We can help you:

  • Develop a practical elemental impurities testing strategy based on your product and manufacturing process
  • Perform risk assessments aligned with ICH Q3D, USP <232>/<233>, and EP requirements
  • Identify which elemental impurities require evaluation and establish scientifically justified acceptance limits
  • Determine whether qualitative screening, quantitative analysis, or ongoing monitoring is appropriate
  • Evaluate testing requirements for APIs, excipients, drug products, and manufacturing components
  • Design efficient testing programs that minimize unnecessary analyses while maintaining regulatory compliance
  • Generate high-quality analytical data using validated ICP-MS methodologies
  • Support regulatory submissions with scientifically defensible documentation and technical expertise
  • Assist with specification development, including combination products and products requiring additive limit calculations

Confidence for Every Stage of Development

Method Development
Custom ICP-MS and ICP-OES methods for challenging product matrices.

USP<233> ICH Q3D Validation
Validation and verification supporting accuracy, precision, linearity, recovery and system suitability.

Routine GMP Testing
Release testing, stability studies, investigations and supplier qualifications.

Deliver Actionable Results
Experience analytical chemists help define practical testing strategies and deliver clear, compliance-ready findings.


 

icp-ICP-MS_Techniques

Products

  • Tablets
  • Capsules
  • Injectables
  • Liquids
  • Cream & Ointments

Raw Materials

  • APIs
  • Excipients
  • Intermediates
  • Catalysts

Packaging

  • Glass
  • Rubber Closures
  • Elastomers
  • Polymers

Advanced Materials

  • Biologics
  • Medical Devices
  • Combination Products
  • Research Materials
icp-ICP-MS_Techniques

 A Risk-Based Approach to Compliance 

 Every product presents unique challenges. Quantum works collaboratively with clients to develop customized testing strategies that address regulatory expectations while considering product composition, manufacturing processes, and lifecycle stage. Whether you require a comprehensive validation program, targeted screening, or support for a risk assessment, we deliver solutions designed to meet your specific objectives. 

Regulatory Expertise You Can Trust

Our team helps clients navigate global elemental impurities requirements, including:

  • ICH Q3D
  • USP <232> Elemental Impurities—Limits
  • USP <233> Elemental Impurities—Procedures
  • European Pharmacopoeia (EP)

From early development through commercial release, Quantum provides the analytical expertise and regulatory support needed to help you achieve compliance with confidence.

Accreditation_Logos1

 

SPEAK TO AN EXPERT

We're Not Just a Lab, We're a Testing Partner You Can Rely On

Built for Regulated Industries

30 years of solving complex product and compliance challenges

Real People. Real Answers.

Work directly with scientists who guide you, not just test for you.

Testing That Goes Deeper

We don’t just test — we troubleshoot, explain, and guide.

Ready to Get Results You Can Trust?

Book a consult with our team to discuss your goals, get expert input, and map out your next steps — with no pressure, just clarity.

BOOK A CONSULT