Elemental Impurities Analysis for Agrochemicals

Elemental Impurities Analysis for Agrochemicals

Elemental impurities are unwanted chemical substances that remain with the active pharmaceutical ingredient (API) or drug product. These observed impurities in the products may arise from several sources, or may be derived from sources such as starting materials, intermediates, reagents, solvents, catalysts and reaction by-products. The amount of elemental impurities found in the agrochemical determines the ultimate safety of the final product, and elemental impurities should be controlled within acceptable limits. Therefore, identification, quantification, characterization and control of impurities in agrochemicals are key parts of the agrochemical development process.

Figure 1. Chemical structures of brassinolide and propionylbrassinolide and its impurities. (Lidong, C.; et al. 2018)

Possible Sources of impurities

• Formed due to the inherent instability of the active substance
• Due to incompatibility with the added excipients
• As a result of interactions with packaging materials and containment systems (CCSs)

Features of Our Services

• Perform these analyses at low ppb levels
• High accuracy and speed
• Support both laboratory and in-line detection

Separation and Identification of Impurities in Agrochemicals

BOC Sciences' comprehensive analytical capabilities and over 20 years of experience in the identification of unknown components and impurities allow us to solve the difficult issues that arise in the separation and identification of element impurities in agrochemical.

• Our constantly updated laboratory is equipped with advanced instrumentation to identify impurities rapidly.
• Our proven methods for specific material types allow us to effectively separate and identify components, ultimately determining the source of impurities.
• We are equipped with a trace-level, elemental analysis technique that uses the emission spectra of a sample to identify and quantify the elements present.

Figure 2. Determination of propionylbrassinolide and its impurities by High-Performance Liquid Chromatography. (Lidong, C.; et al. 2018)

Heavy Metal and Impurities Testing

Heavy metals such as Chromium (Cr), Cadmium (Cd), Mercury (Hg), Lead (Pb), Nickel (Ni) and Thallium (Tl) are potentially hazardous in combined or elemental forms. Heavy metals are highly soluble in the aquatic environment, so they can be easily absorbed by organisms. Heavy metals above allowable limits often leads to adverse effects in humans, other organisms and the environment at large.

• Our team has extensive project experience in handling complex metal impurities ranging from silver and silver oxides to trace amounts of arsenic and lead.
• Our experts have developed robust methods that can be fully validated to support your laboratory studies and product registration.
• We have a range of equipment and expertise to allow us to complete heavy metals and impurities testing, including trace metals.

Instruments

• Inductively-Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
• Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)
• Liquid Chromatography and Ultraviolet Detection (LC/UV)
• Preparative Liquid Chromatography (LC)

BOC Sciences Advantages

• Highly specialized technical and analytical services for the worldwide registration and regulatory compliance of agrochemicals
• Robust analytical testing programs that span from research and product development through the production process to final product
• Relies on broad industrial experience, ensuring that all of our work meets the high standards expected by our clients
• Our regulatory experts, toxicology consultants, scientists and inspectors will ensure that you receive maximum levels of guidance, testing and inspection you need.

Reference

• Lidong, C.; et al. Determination of Propionylbrassinolide and Its Impurities by High-Performance Liquid Chromatography with Evaporative Light Scattering Detection. Molecules. 2018. 23(3): 531.