Expertise
Study plans and reports are developed in accordance with GLP principles and guidelines, following standard procedures while addressing the specific needs of each client.
Renolab provides GLP analytical studies and laboratory testing to support the preparation of analytical dossiers required for regulatory submissions.
The laboratory performs a wide range of analytical activities for agrochemicals, biocides, cosmetics, pharmaceuticals, additives and other industrial chemical products.
Study plans and reports are prepared in accordance with GLP principles and standard operating procedures, ensuring that analytical data meet the requirements of international regulatory frameworks.
Chemical and Physical Characterisation
Renolab GLP is able to provide all the tests necessary to produce analysis dossiers for the registration of agrochemicals, biocides, cosmetics, drugs, additives and other industrial chemical products.
- Development and validation of analysis methods for technical active substance and formulated products
- Analysis of formulated products and issue of analysis certificates
- Physical and chemical analysis of technical active substanceand formulated products
- General risk studies for transport and storage
- Stability studies (cold storage, accelerated storage, shelf life up to two years) with monitoring of physical and chemical parameters and condition of packaging
- Checking and control of the stability of active substances
- Chemical and physical compatibility of tank mixes on the client’s request
- Effectiveness of cleaning procedures
5-Batch Analysis
Renolab performs 5-batch analysis for technical active substances as part of the analytical data required for regulatory dossiers.
- Screening: purity and impurity profile
- Analysis of the active substance and impurity contents of the 5 batches, including impurities of metals and heavy-metals by ICP
- Validation of analysis methods under European and international standards
- Spectroscopic characterisation of 5 batches: UV/VIS and MS (IR and NMR can be supplied through outsourcing)
- Synthesis and/or column separation of relevant and significant impurities (this type of analysis can be supplied through outsourcing)
GLP Residue Studies
Renolab performs analytical activities supporting residue studies and the development of analytical methods.
Activities include:
- Development and validation of single and multi-residue analysis methods for the determination of active substances and metabolites in crops, animal products, soil and water.
- Indipendent Laboratory Validations (ILV)
- Residue studies.
- Storage stability of residues in various types of materials or specimens.
- Residues of active ingredients on the test material surfaces (stainless steel, plastic and glass) after rinsing (twice) and wiping test.
- Residue determination in Dislodgeable Foliar Residue (DFR) Studies
Microbiological studies
Renolab, which is specialized in the issuance of analytical dossier for regulatory registration of plant protection products, now applies its experience in the field of microbiological (fungal biocontrol) products.
- Physical-chemical characterization of fungal pesticides as biocontrol agents, according to FAO recommendations and official methods (CIPAC, OECD, EC).
- Shelf life studies.
- Five-batch analyses.
- Active ingredient determination, including method validation, for example direct and indirect detection of spore density and spore viability on spore powder formulation of technical fungal biocontrol products.
- Confirmation of strain identity by PCR (Polymerase Chain reaction).
- Methods for the detection of microbial contaminants according to OECD 65 and SANCO/12116/2012 and official methods (ISO, UNI-EN); according to the requirements of Regulation (EC) No 1107/2009 and Regulation (EC) No 283/2013.
- Screening of metabolites produced by fungal biocontrol agents through chromatographic separation and mass spectrometry detection (Qtof-MS/MS).
In vitro
Testing
At Renolab, we can provide expert support to clients in designing in vitro testing strategies aimed at achieving human risk classification efficiently and in full compliance with current European regulations. These approaches are developed to minimize timelines and costs while avoiding the use of animals, in accordance with applicable regulatory requirements.
Renolab can test individual ingredients, mixtures or final products using a broad range of in vitro methods that meet both testing and compliance requirements.
Cytotoxicity Tests
- MTT Test (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium) to measure cell viability.
- XTT Test/XTT Test 2,3-bis(2-metossi-4-nitro-5-sulfofenil)-2H-tetrazolio-5-carbossanilide to measure cell viability (ISO 10993-5)
- LDH Test (Lactate Dehydrogenase) to measure cellular damage.
- Cell Morphology Test to examine the integrity and shape of the cells.
Skin Corrosion and Skin Irritation
- In vitro in 3D tissue models for skin corrosion (OECD 431) and skin irritation (OECD 439, ISO 10993-23)
- In chemico skin corrosion testing with Corrositex™ (OECD 435)
Serious Eye Damage and Eye Irritation
- Bovine corneal opacity and permeability test (OECD437) for eye damage
- Reconstructed human cornea-like epithelium test (OECD 492) for ocular irritation (EpiOcular)
- SkinEthic™ RhCE test method for eye hazard identification (OECD 492B)
- Ocular Irritection®– Eye Irritation Test (OECD 496)
Skin Sensitization
- DPRA and kinetic DPRA (OECD 442C, ISO 10993-10)
- KeratinoSens (OECD 442D, ISO 10993-10)
- U-SENS, h-CLAT (OECD 442E, ISO 10993-10)
Mutagenicity/Genotoxicity
- Bacterial reverse mutation (Ames) test (OECD 471, ISO 10993-3)
Other Services
Support for R&D projects
Renolab staff have specific competences for the support of R&D activities in the formulation and in vitro and in vivo trial of new products.
- Single and multi-residue analyses of pesticides in crops, raw materials and finished products
- Single and multi-residue analyses to identify and measure mycotoxins in crops and finished products
- Technical training and refresher courses on formulation techniques
- Quality controls by the procedures and to the schedules required by production departments
FAQ
What are GLP analytical studies?
GLP analytical studies are laboratory studies performed according to Good Laboratory Practice principles to ensure the quality, reliability and regulatory acceptance of generated data.
What is 5-batch analysis of an active substance?
5-batch analysis is a study used to evaluate the purity, impurity profile and composition of an active substance across five production batches.
What are residue studies?
Residue studies determine the presence of active substances or metabolites in matrices such as crops, soil, water or animal products.
What is chemical and physical characterisation?
Chemical and physical characterisation includes analytical studies used to determine the composition and key properties of technical active substances and formulated products.
What are in vitro safety tests?
In vitro tests are laboratory methods used to evaluate biological effects such as cytotoxicity, irritation or sensitisation without the use of animal testing.
Which industries require GLP analytical studies?
GLP analytical studies are commonly required for regulatory submissions in sectors such as agrochemicals, biocides, cosmetics, pharmaceuticals and industrial chemicals.