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Chemicals, Biological, And Heavy Metals Analysis

Our state of the art laboratory is capable of supporting the testing and analysis of wide range of herbal products as per, WHO guidelines, cGMP guidelines, international standards and sponsor specific requirements. We guarantee a fast, economic and reliable services for analytical testing of raw herbs or formulations, phytochemical investigations, microbiological content, and toxic chemical analysis. We provide following services;

Toxicological And Microbial Analysis.

The World Health Assembly has emphasized the need to ensure the quality of medicinal plant products by using modern control techniques and applying suitable standards. In its guidelines WHO has described a series of tests for assessing the quality of medicinal plant materials. These guidelines are applied to all the medicinal plant products and a general common sense is applied to test of other potential contaminants suspected. These guidelines are also adopted by the EMA, the US-FDA. We offer to test a List of contaminants in three categories

Description

  1. Chemical contaminants
    • Toxic metals and non-metals - Arsenic (As), Lead (Pb), Cadmium (Cd), Chromium (Cr), Mercury (Hg).
    • Persistent organic pollutants - a series of common pesticides and insecticides.
    • Mycotoxins and endotoxins- Total aflatoxins (B1 + B2 + G1 + G2), Aflatoxin B1.
    • Solvents occurring as contaminants - We test for the solvents in class 1, 2, and 3 as defined by the ICH.
  2. Biological contaminants
    • Microbiological contaminants - Total aerobic plate count, Total yeasts and molds, Salmonella and Shigella spp, Escherichia coli.
    • Parasitic contamination.
  3. Other tests (recommended by the WHO and the EMA guidelines)
    • Characters - macroscopic and microscopic characteristics of the herbal substance, Chromatographic characteristics
    • Foreign matter - Insects and other animal contamination including animal excreta, as well as other species of plants.
    • Total ash - Ash insoluble in hydrochloric acid.
    • Water soluble extractive.
    • Particle size
    • Water content

Standard methods described in WHO guidelines are used to perform the tests and the limits set by WHO and various other regulatory organizations are followed (unless specified by the sponsors). For the finished formulations we also test for extractables and leachables such as phthalate esters, cyanides, nitrosamines, benzopyrenes, trace metals etc. These chemicals can be released/migrated from primary and secondary packing materials such as containers, container liners, closures, stopper over-seals, etc.