Chemical Testing & Characterisation

Precision analytics to ensure quality, safety, and regulatory compliance.

At IIBAT, we provide comprehensive chemical testing and characterization services for pharmaceuticals, medical devices, agrochemicals, biocides, and industrial chemicals. Our capabilities span impurity profiling, stability studies, material characterization, and physicochemical testing—all aligned with international regulatory guidelines.

We support the full product development lifecycle, from early-stage R&D to registration, scale-up, and post-market surveillance.

🧪 What is Chemical Characterisation?

Chemical characterization involves analyzing the identity, purity, composition, and stability of a substance or material. This data is essential for:

  • Regulatory submissions (e.g., ICH, REACH, EPA)
  • Quality control and release testing
  • Manufacturing validation
  • Risk assessments for human and environmental safety

Whether you are submitting an IND, a 510(k), or a REACH dossier, our analytical insights ensure your data stands up to scrutiny.

🔍 Our Chemical Testing Services

We offer a full spectrum of chemical analysis and radiolabeled testing services to support impurity profiling, method development, stability, and environmental fate studies. These services are critical for ensuring product quality, safety, and regulatory compliance across pharmaceuticals, agrochemicals, medical devices, and specialty chemicals.

1. Impurity Profiling & Identification

Objective: Identify and quantify known and unknown impurities, including genotoxic or process-related substances.

Techniques:

  • HPLC, GC, LC-MS/MS, ICP-MS
  • Forced degradation + mass spectral analysis
  • Structure elucidation of unknowns

Guidelines: ICH Q3A (organic), Q3B (degradants), Q3C (solvents), Q3D (elemental impurities)

✅ Supports: Drug substance quality, risk assessments, cleaning validation

2. Residual Solvents & Elemental Impurities Testing

Objective: Detect and quantify trace-level solvents and metals in accordance with global safety limits.

  • Residual Solvents (ICH Q3C):
    • Class 1 (e.g., benzene), Class 2, Class 3 solvent testing
    • Headspace GC with flame ionization or mass detection
  • Elemental Impurities (ICH Q3D):
    • 24 metal elements across oral, parenteral, and inhalation limits
    • Performed using ICP-MS or ICP-OES

✅ Supports: Pharmaceutical filings, nutraceuticals, biologics, and cosmetics

3. Stability & Forced Degradation Studies

Objective: Assess how a product or material degrades over time or under stress.

Types:

  • Long-term & accelerated stability (ICH Q1A–Q1F)
  • Photostability (ICH Q1B)
  • Thermal, oxidative, hydrolytic, and pH-induced degradation

Deliverables:

  • Stability indicating assay methods
  • Shelf-life estimation & retest period determination
  • Container-closure compatibility evaluations

✅ Supports: Regulatory submissions, storage labeling, post-approval changes

4. Physicochemical Property Testing

Objective:
Determine core physical and chemical parameters of active substances and formulations.

We test:

  • Solubility (aqueous & organic solvents)
  • Partition coefficient (logP/logD)
  • pKa values
  • Particle size distribution (laser diffraction, microscopy)
  • Hygroscopicity
  • Melting point, boiling point
  • Surface area (BET analysis)

✅ Supports: BCS classification, formulation design, analytical method development

5. Polymer & Material Characterization

Objective: Analyse raw materials, packaging components, and medical device polymers.

Capabilities:

  • FTIR for functional group analysis
  • DSC & TGA for thermal behavior
  • GPC for molecular weight
  • Leachables & extractables (USP <1663>, ISO 10993-18)
  • Identification of plasticizers, stabilizers, residual monomers

✅ Supports: ISO 10993 compliance, packaging interaction studies, extractables safety evaluations

6. Household Pesticide & Biocide Formulation Analysis

Objective: Ensure the identity, consistency, and safety of domestic use products.


We offer:

  • Active ingredient quantification
  • Formulation shelf-life and thermal stability
  • pH, viscosity, flash point, density testing
  • Microbial effectiveness (preservatives)
  • Safety and efficacy studies per WHO/EPA guidelines

✅ Supports: Label claims, registration of repellents, disinfectants, surface sprays

Why Choose Us?

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Full-spectrum analysis – from impurities to polymer leachables

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Regulatory-ready data for global compliance

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End-to-end support from development to submission