Extractable & Leachable Testing

650+ E/L Studies Done

Our Deliverables

Custom Extractables and Leachables studies for all types of container closure systems and primary packaging materials including labels, printings and adhesives.
Consultancy for Extractables and Leachables studies in all phases of development of a container closure system.
Chemical Characterization of Medical Devices as per ISO 10993.
Toxicological assessment of extractables.
USP/EP Chapter characterization studies of materials.
Glass Delamination Studies.
Material selection for devices/packaging and vendor qualification. Seminars and trainings on Extractables and Leachables.

Our Instrumentation

TD - GCMS
HS - GCMS
LC - MS/MS
HPLC
ICP - MS
SEM - EDS
FTIR
UV Spectroscopy

TD-GCMS

TD-GCMS (Thermal Desorption - Gas Chromatography Mass Spectrometry) is used for identifying and quantifying volatile and semi-volatile organic compounds (VOCs & SVOCs) in various materials and environments.

Key Insights:

Chemical Composition - Identifies and quantifies VOCs, SVOCs, and unknown compounds.
Thermal Stability & Off-Gassing - Determines emissions from materials under heat.
Air Quality & Environmental Testing - Detects pollutants, industrial emissions, and indoor air contaminants.
Automotive & Aerospace - Analyzes in-cabin air quality and polymer emissions.

Extractables & Leachables (E&L) - Identifies volatile leachables in medical devices and packaging.
Material & Polymer Testing - Detects additives, degradation by-products, and crosslinking behavior.
Forensic & Failure Analysis - Investigates contamination, product failures, and combustion residues.
Food & Fragrance Analysis - Profiles flavors, aromas, off-gassing, and spoilage markers.

HS-GCMS

HS-GC/MS (Headspace Gas Chromatography-Mass Spectrometry) is used for analyzing volatile organic compounds (VOCs) in liquids, solids, and complex matrices.

Key Insights:

Residual Solvent Analysis - Detects trace solvents in pharmaceuticals, polymers, and coatings.
Volatile Impurities & Contaminants - Identifies residual monomers, degradation products, and off-gassing compounds.
Extractables & Leachables (E&L) - Analyzes volatile leachables from medical devices, packaging, and food containers.
Aroma & Flavor Profiling - Examines volatile compounds in food, beverages, perfumes, and essential oils.

Automotive & Aerospace Testing - Evaluates in-cabin air quality, fuel residues, and polymer emissions.
Environmental & Air Quality - Detects industrial emissions, soil VOCs, and indoor air pollutants.
Forensic & Failure Analysis - Identifies unknown volatiles in product defects, contamination, and fire residues.

LC-MS/MS

LC-MS/MS (Liquid Chromatography - Tandem Mass Spectrometry) is used for highly sensitive and selective identification and quantification of organic compounds in complex mixtures.

Key Insights:

Pharmaceutical Analysis - Identifies drug metabolites, impurities, and degradation products.
Bioanalysis & Toxicology - Detects biomarkers, hormones, toxins, and therapeutic drug levels in biological samples.
Food & Beverage Testing - Identifies contaminants, pesticides, mycotoxins, and adulterants.
Extractables & Leachables (E&L) - Detects non-volatile leachables in medical devices, packaging, and food containers.

Environmental Monitoring - Measures pollutants, pharmaceuticals in wastewater, and trace contaminants in air and soil.
Polymer & Material Testing - Analyzes additives, stabilizers, and degradation products.
Forensic & Doping Analysis - Identifies drugs of abuse, performance-enhancing substances, and unknown compounds.

HPLC

HPLC (High-Performance Liquid Chromatography) is used for separating, identifying, and quantifying components in complex liquid mixtures.

Key Insights:

Pharmaceutical Analysis - Measures drug purity, potency, degradation products, and impurities.
Bioanalysis - Detects biomolecules like proteins, peptides, and metabolites in biological samples.
Food & Beverage Testing - Identifies preservatives, additives, vitamins, and contaminants.
Extractables & Leachables (E&L) - Analyzes non-volatile leachables in medical devices and packaging.

Environmental Monitoring - Detects pesticides, industrial chemicals, and pollutants in water and soil.
Polymer & Material Testing - Characterizes additives, plasticizers, and degradation by-products.
Forensic & Doping Analysis - Identifies drugs, toxins, and controlled substances.

ICP-MS

ICP-MS (Inductively Coupled Plasma Mass Spectrometry) is used for ultra-trace detection and quantification of metals and inorganic elements in various samples.

Key Insights:

Pharmaceutical Analysis - Detects heavy metal impurities as per regulatory guidelines (ICH Q3D).
Bioanalysis & Toxicology - Measures trace metals in biological fluids, tissues, and forensic samples.
Food & Beverage Testing - Identifies toxic metals (lead, arsenic, mercury, cadmium) and essential minerals.
Environmental Monitoring - Analyzes water, soil, and air for metal contamination and pollutants.

Material & Polymer Testing - Detects elemental composition and impurities in polymers, coatings, and catalysts.
Extractables & Leachables (E&L) - Quantifies trace metals leaching from medical devices and packaging.
Nutritional & Agricultural Testing - Measures essential nutrients and contaminants in fertilizers, plants, and animal feed.

SEM-EDS

SEM-EDS (Scanning Electron Microscopy with Energy Dispersive Spectroscopy) is used for high-resolution imaging and elemental composition analysis of solid materials.

Key Insights:

Microstructure Analysis - Provides detailed imaging of surface morphology and material defects.
Elemental Composition - Identifies and quantifies elements present in a sample (qualitative & semi-quantitative analysis).
Failure & Defect Analysis - Detects cracks, corrosion, contamination, and material degradation.
Particle & Powder Characterization - Examines size, shape, and elemental makeup of particles in powders, coatings, and filters.

Forensic & Contamination Analysis - Identifies unknown residues, contaminants, and wear debris in various industries.
Metallurgical & Alloy Testing - Determines phase composition, grain structure, and element distribution in metals.
Polymers & Composite Analysis - Evaluates fillers, additives, and degradation in plastic and composite materials.
Cataract Lens Analysis - Studies surface defects, material composition, and degradation of intraocular lenses (IOLs).

FTIR

FTIR (Fourier Transform Infrared Spectroscopy) is used for identifying and characterizing organic and inorganic materials based on their molecular vibrations.

Key Insights:

Material Identification - Confirms the presence of functional groups and chemical bonds in unknown substances.
Polymer & Plastic Analysis - Identifies polymer type, additives, and degradation products.
Pharmaceutical Testing - Characterizes drug substances, excipients, and counterfeit medicines.

Contaminant & Failure Analysis - Detects unknown residues, surface contamination, and material defects.
Coatings & Adhesives Evaluation - Assesses bonding efficiency, composition, and curing completeness.
Forensic & Food Testing - Identifies adulterants, additives, and spoilage in food and forensic samples.

UV Spectroscopy

UV-Vis (Ultraviolet-Visible Spectroscopy) is used for quantitative and qualitative analysis of compounds based on their light absorption properties.

Key Insights:

Concentration Determination - Measures the absorbance of solutions to determine the concentration of analytes (Beer-Lambert Law).
Purity Analysis - Detects impurities in pharmaceuticals, chemicals, and biological samples.
Polymer & Plastic Testing - Evaluates degradation, oxidation, and UV stability.

Food & Beverage Analysis - Identifies colorants, additives, and contaminants in food products.
Pharmaceutical & Drug Analysis - Tests active pharmaceutical ingredients (APIs) and dissolution profiles.
Coatings & Dyes Characterization - Measures optical properties, stability, and fading resistance.

Extractable & Leachable Testing

650+ E/L Studies Done

Our Deliverables

TD-GCMS

Key Insights:

HS-GCMS

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LC-MS/MS

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HPLC

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ICP-MS

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SEM-EDS

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FTIR

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UV Spectroscopy

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Why GVS Cibatech?

Extractable & Leachable Strategy

For Consultation/Quote, Call + 91-22-49674884 or Write to us