Quality Control Along International Standards
With the constant increase in the use of dietary supplements worldwide and the rapid expansion of the global market, the safety and quality of herbal materials and finished herbal products have become a major concern for health authorities, pharmaceutical industries and the public. The safety and efficacy of herbal extracts largely depend on their quality.
Because of their often complex and variable nature, control of raw materials, storage and processing assume particular importance in the manufacture of herbal products. The raw materials are sourced from approved vendors so as to conform to standard specifications. These are then analyzed to ensure that active constituents are present as detailed in the QC manual. Our QA system ensures the consistency and quality of the finished products.
Arjuna strengthened the laboratory facilities with many modern instruments and equipment like GC-MS for checking the presence of pesticides. Head space GC accurately analyses traces of residual solvents to meet the stringent specifications. Arjuna has been using Inductively Coupled Plasma Mass Spectrometry(ICP-MS)ever since it was introduced commercially and gained general acceptance in many types of laboratories. The lab staff and scientists have been trained in the use of this equipment and can detect traces of any metal. Arjuna uses other sophisticated testing equipment like HPTLC(Camag,Swiss) for complete finger printing of complex molecule.
While the QA department tests chemical parameters and organoleptic qualities of all types of products, the modern microbiology laboratory functions for testing microbiological parameters of products.
Arjuna is fully equipped to meet the challenging new stringent standards set by EU by the amendment of the “Contaminants Regulation” EC/1881/2006 with regard to PAHs.
Close on the heels of a three-tier monitoring system, Arjuna has rolled out a quality control manual to further streamline quality assurance and quality control in its projects. The manual details the steps in line with the WHO guide lines to be followed while manufacturing, quality of materials to be used, and the testing procedures to be carried out.Besides, the specifications, methods to be adopted for ensuring quality have been listed out in detail.
A four pole mass spectrometry device of high sensitivity, the Inductively Coupled Plasma-MS is particularly advantageous for trace determinations of metals like Pb, Cd, Hg, As, etc. and surveying for unknown or unexpected elements. The detection capability of 0.1 ppm at 1% wt. is superior to the often compared ICP-AES of the same sample type. Comparatively, the ICP-MS also has the ability to obtain information about isotopes, which are common for many elements and missed by traditional mass spectrometry.
A simple, fast and efficient upgrade to conventional Thin Layer Chromatography, this higher performance, automation-enhanced technique has improved the resolution and thus separation ability of plated analyses. A standard in the pharmaceutical industry, this advanced technique far surpasses more crude qualitative assessment procedures by providing reproducible, quantitative analyses important for fingerprinting and GMP conformity.
Gas Chromatography and Mass Spectrometry in combination specialize in separating out and quantifying volatile and semi-volatile analytes. Pesticide testing is a good example of its use. GC is a temperature-controlled process that separates out the components of a given sample by weight and size, while the MS characterizes and quantifies each component accordingly. GC MS is eco-friendly and performs at high speeds for increased productivity.
GC WITH HEADSPACE
Headspace sampling is an automated addition to conventional GC, which allows for improved contrasting between volatile oils and other components in a given mixture. With a more refined sample, the purity and relative amounts of a particular substance in the mixture can be obtained with greater ease, speed and accuracy.
The high performance, preparative use of Liquid Chromatography isolates known or unknown compounds from a mixture for further study of structure, activity, toxicology, etc. This instrument advances the practice of traditional separation methods, like extraction, distillation or crystallization by using high flow rates and large columns for precise and pure outputs. HPLC can be used for compound analysis, but lacks the sensitivity required to tease out compounds that are structurally very similar. For this reason, our lab defers to more sensitive instrumentation in analyzing the HPLC isolated compounds.