Our specialized lab offers OECD-GLP compliant tests for:
-Physical & chemical properties
-5 batch analysis
Analytical Method Development
JDM has hands-on experience in developing and optimizing methods at its analytical facilities, equipped with an array of tools and techniques.
Validation and Troubleshooting
We can also support Analytical Method Validation as per ICH/OPPTS guidelines and can cater to any client-specific needs. JDM supports method verification or method transfer process. It transfers the validated methods between laboratories and sites to maintain their robustness and ensures that results are precise and accurate
The safety of a product is not only dependent on the toxicological properties of the active substance, but also on the impurities formed during the various chemical transformations. Therefore, characterization, quantification, and control of impurities in the drug substance and drug product are important parts of product development for obtaining marketing approval. Identifying and controlling impurities in very small quantities of a drug substance is a complex task, partly because it adds steps the process (thereby making it less competitive) and partly because the syntheses of impurities are not typically described in literature and must be designed in the lab.
At JDM we take a special interest in synthesis of impurity standards.
Starting 2018, our toxicology division will offer these services, in accordance with current global regulatory guidelines.
Our team of experienced toxicologists will design effective study plans that meet program objectives and ensure fast turnaround times.
Battery of Genetic Toxicology
Teratogenicity, Fertility Studies & Generation Studies.
90 days repeat dose studies via different routes
Eco Toxicological Studies
Bird, Fish, Bee, Algae, Earthworm, Daphnia & Soil Organism Toxicity
Acute Inhalation, Skin Irritation, Mucous-Membrane Irritation, Guinea Pig Maximization Studies. Acute Dermal, Oral & Parenteral Toxicity;
Sub-acute Dermal, Oral, Inhalation, Intravenous & Intraperitonial Studies
Field Trials and Residue Analysis
Residues remaining in or on plants are often unavoidable even after a pesticide has been applied in accordance with Good Agricultural Practices (GAP).
At JDM, supervised residue trials are designed so that the highest likely residues are present in crop e.g. by using the highest application rate and shortest pre-harvest interval (PHI) consistent with GAP. This is in order to mimic potential worst-case residue levels in crop at harvest and at the storefront. Trials are conducted, taking into account variations in environmental and climactic conditions.