Raw Materials and Excipient Testing

 Ensuring Raw Material Quality from the Start 

Raw materials are the foundation of every high-quality product—from pharmaceuticals and biologics to over-the-counter (OTC) medicines, nutraceuticals, cosmetics, personal care, medical device, and health products. Before manufacturing begins, every incoming material should be verified to ensure it meets quality, safety, performance, and regulatory requirements. Even minor variations in identity, purity, potency, contaminant levels, or physical characteristics can disrupt manufacturing, delay product release, increase regulatory risk, and ultimately impact product quality and consumer safety.

Quantum Analytics Group provides GMP analytical testing for pharmaceutical raw materials, excipients, active pharmaceutical ingredients (APIs), process chemicals, botanical ingredients, and specialty materials. Using advanced instrumentation and fit-for-purpose analytical methods, our scientists verify identity, assay, purity, potency, residual solvents, elemental impurities, contaminants, and other critical quality attributes to support supplier qualification, incoming material release, manufacturing investigations, and compliance with USP, EP, BP, JP, and applicable ICH guidelines.

At Quantum Analytics, you work directly with experienced analytical scientists who collaborate with your quality, manufacturing, and development teams to design testing strategies for routine analyses and complex analytical challenges. We provide responsive scientific expertise and reliable, audit-ready data that helps reduce manufacturing risk, accelerate material release, support regulatory compliance, and keep product development and manufacturing moving forward with confidence. 

When Raw Material Testing Matters

Incoming materials can introduce variability, contaminants, impurity risks, specification failures, performance concerns, and release delays across pharmaceutical, OTC, nutraceutical, cosmetic, personal care, and health-product manufacturing. Accurate analytical testing supports material release, supplier qualification, QA review, regulatory documentation, and manufacturing investigations.

Testing Support Includes

  • Identity, assay, purity, potency, and limit testing
  • HPLC, UHPLC, GC, ICP-MS, ICP-OES, FTIR, UV-Vis, and
         wet chemistry
  • USP/NF, EP, BP, JP, and client specification support
  • Residual solvents USP <467> ICH Q3C
  • Elemental impurities USP <232>/<233> ICH Q3D
  • Supplier qualification, CoA verification,
         and investigation support

Material Release Confidence

Confirm that incoming raw materials and excipients match identity, assay, purity, and physical or chemical requirements before use.


Defensible Data

Receive clear, audit-ready analytical reports that support QA, regulatory, manufacturing, and quality-control decisions.

Supplier & CoA Verification

Independently evaluate supplier-reported data, compare alternate vendors, and support new supplier qualification programs.

 

Testing Capbilities

Materials We Test

Quantum Analytics Group supports routine release testing and complex analytical investigations for materials used across pharmaceutical, biotechnology, OTC, nutraceutical, cosmetic, personal care, health-product, compounding, specialty chemical, and other quality-critical manufacturing environments.

Pharmaceutical Raw Materials

Testing support for incoming production materials and quality-control release.

  • Active Pharmaceutical    
          Ingredients (APIs)
  • API intermediates and 
         process materials
  • Buffers, salts, solvents, and 
         reagents
  • Cleaning agents and 
         processing aids
  • Release and investigation 
         samples

 

Excipients & Functional Ingredients

Polymer characterization, additive identification, filler analysis, coating studies, and formulation support.

  • Fillers, binders, coatings, 
         and disintegrants
  • Polymers, sugars, amino 
         acids, and surfactants
  • Preservatives, solvents, 
         and specialty ingredients
  • Compendial and client-
         specified testing
  • Supplier qualification and 
         vendor change support

Botanical, Cosmetic & Specialty Materials

Custom testing strategies for materials that do not fit a simple compendial checklist.

  • Botanical ingredients, 
         cosmetic ingredients, 
         and formulation 
         components
  • Polymers, coatings, 
         surfactants, and product-
         contact materials
  • Unknown contaminants 
         and foreign materials
  • Side-by-side lot and 
         supplier comparisons
  • Method development and 
         troubleshooting

Who We Support

Our raw material and excipient testing services support organizations that need reliable data for quality, supplier, development, and manufacturing decisions.

Pharmaceutical Manufacturers

  Incoming material release, compendial testing, supplier qualification, batch investigations, and regulatory documentation.

Biotechnology Companies

 Testing support for buffers, salts, media components, excipients, specialty ingredients, and development materials. 

CMOs & CDMOs

 Analytical support throughout development, transfer, production, release, and investigation workflows. 

OTC & Consumer Health Manufacturers

 Ingredient verification, incoming material release, supplier controls, and quality investigations for over-the-counter and health products. 

Cosmetics & Personal Care Companies

Identity, purity, contaminant, and performance-related testing for cosmetic ingredients, personal care materials, and formulation components. 

Nutraceutical & Ingredient Suppliers

 Botanical and specialty ingredient testing, CoA support, customer specification testing, impurity evaluation, and quality documentation. 

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Need Raw Material or Excipient Testing?

Contact Quantum Analytics Group to discuss incoming material release, supplier qualification, compendial testing, impurity investigations, method development, or custom analytical testing for pharmaceutical, OTC, nutraceutical, cosmetic, personal care, and specialty materials.

(800) 448-2968

 

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