Quercus Labo
GMP-certified contract QC laboratory offering end-to-end analytical services for pharmaceutical and life-science organizations. Services cover chemical and microbiological testing, method development and validation, stability studies, environmental and cleanroom monitoring, elemental impurity analysis, and EU batch release/QP support. The laboratory holds ISO/IEC 17025 accreditation and GMP licences and performs testing in compliance with pharmacopeial and ICH requirements.
Industries
Nr. of Employees
small (1-50)
Products
Stability Testing
GMP stability studies complying with all ICH requirements, verified on-site.
GMP Stability Testing Services
Comprehensive stability and shelf-life testing services for finished pharmaceutical products in accordance with ICH guidance, performed in a GMP-controlled environment.
EU Import & QP Batch Release Services
Quercus Labo provides authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC, featuring certified batch release testing by qualified persons (QPs) in accordance with Annex 16 of the EU GMP Guidelines.
QC Chemical Analysis
GMP-certified quality control laboratory services supporting analytical needs from pharmacopoeial analysis of raw materials, APIs, and IMPs to finished medicinal products.
Elemental Impurities Analysis
Comprehensive GMP testing service providing ICP-MS analyses for elemental impurities and heavy metals in compliance with ICH Q3D guidelines.
Method Development and Validation
Quercus Laboratory provides method development and validation services in compliance with GMP and ICH Q2, ensuring analytical methods are well-defined, robust, and reliable.
Stability Testing
GMP stability studies complying with all ICH requirements, verified on-site.
GMP Stability Testing Services
Comprehensive stability and shelf-life testing services for finished pharmaceutical products in accordance with ICH guidance, performed in a GMP-controlled environment.
EU Import & QP Batch Release Services
Quercus Labo provides authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC, featuring certified batch release testing by qualified persons (QPs) in accordance with Annex 16 of the EU GMP Guidelines.
QC Chemical Analysis
GMP-certified quality control laboratory services supporting analytical needs from pharmacopoeial analysis of raw materials, APIs, and IMPs to finished medicinal products.
Elemental Impurities Analysis
Comprehensive GMP testing service providing ICP-MS analyses for elemental impurities and heavy metals in compliance with ICH Q3D guidelines.
Method Development and Validation
Quercus Laboratory provides method development and validation services in compliance with GMP and ICH Q2, ensuring analytical methods are well-defined, robust, and reliable.
Services
Compendial and instrumental chemical testing of raw materials, APIs and finished products across a wide range of dosage forms including solids, injectables, creams, suspensions and high-potency materials. Includes residual solvent, related substances, assay and physical tests.
Analytical method development and validation services to ICH/pharmacopoeial standards, including quantitative and limit-test validations and support for method transfer between laboratories.
Design and execution of cleaning validation programs, analytical method development for trace-level API residues, and swab/sample analysis for chemical and microbiological contaminants.
Routine microbiological testing, preservative efficacy (challenge) testing, endotoxin testing and purified water microbiological/TOC analysis integrated into stability or release protocols.
Active air and compressed gas sampling for microbial and non-viable particle assessment, cleanroom qualification and ongoing environmental monitoring programs.
Risk-based screening and quantitative analysis of elemental impurities across APIs, excipients and finished products using ICP-MS/ICP-OES and validated sample preparation.
Compendial and instrumental chemical testing of raw materials, APIs and finished products across a wide range of dosage forms including solids, injectables, creams, suspensions and high-potency materials. Includes residual solvent, related substances, assay and physical tests.
Analytical method development and validation services to ICH/pharmacopoeial standards, including quantitative and limit-test validations and support for method transfer between laboratories.
Design and execution of cleaning validation programs, analytical method development for trace-level API residues, and swab/sample analysis for chemical and microbiological contaminants.
Routine microbiological testing, preservative efficacy (challenge) testing, endotoxin testing and purified water microbiological/TOC analysis integrated into stability or release protocols.
Active air and compressed gas sampling for microbial and non-viable particle assessment, cleanroom qualification and ongoing environmental monitoring programs.
Risk-based screening and quantitative analysis of elemental impurities across APIs, excipients and finished products using ICP-MS/ICP-OES and validated sample preparation.
Expertise Areas
- Quality control testing
- Analytical method development & validation
- Elemental impurities analysis (ICH Q3D)
- Microbiological testing and preservative efficacy (PET)
Key Technologies
- High-performance liquid chromatography (HPLC/UHPLC)
- Gas chromatography (GC, GC-FID)
- Evaporative light scattering detection (ELSD)
- Inductively coupled plasma mass spectrometry (ICP-MS)
News & Updates
Overview of PSD analysis methods (laser diffraction, DLS, microscopy, sieving, sedimentation), their role in formulation, QC and process optimisation, and trends toward PAT integration.
Uses of DSC for polymorphism analysis, purity assessment, thermal stability evaluation, drug–excipient interaction studies and batch consistency verification.
Explanation of preservative efficacy testing (PET), challenge study design, relevant USP/EP expectations and integration into stability programs.
Discussion of the importance and procedures for friability and disintegration testing for tablets and capsules and their role in QC and formulation optimisation.
Overview of PSD analysis methods (laser diffraction, DLS, microscopy, sieving, sedimentation), their role in formulation, QC and process optimisation, and trends toward PAT integration.
Uses of DSC for polymorphism analysis, purity assessment, thermal stability evaluation, drug–excipient interaction studies and batch consistency verification.
Explanation of preservative efficacy testing (PET), challenge study design, relevant USP/EP expectations and integration into stability programs.
Discussion of the importance and procedures for friability and disintegration testing for tablets and capsules and their role in QC and formulation optimisation.