Total Herb Solutions USA / America
 
Herbal Analysis Laboratories,Marker compounds for herbals,Phytochemical evaluation,Heavy metals testing in herbals,stability testing of nutraceuticals,dietary supplements,

Because of complexity of the chemical composition, the analysis of herbal drug is the major problem in the development of the herbal drug industry. THS is first and unique of its kind in the country to establish exclusive herbal drug testing facility in Mumbai. In order to ensure quality of final product herbals has to go through battery of quality control parameters. A proper integration of physical, chemical, microbial, spectral and chromatographic analysis will ensure proper analysis of herbals. The organization is established to cater the herbal drug standardization need comprising of organoleptic, microscopical, physical, chemical, chromatographic testing, metal and aflatoxin contamination, etc. The laboratory is fully equipped with modern instrument and availability of more than 50 marker compounds, skilled and appropriately trained technical manpower.


Physicochemical analysis : Often plays important role in herbal drug standardization. These tests are simple and quick to perform and give valuable information about the nature and purity of a drug. Some of the parameters like ash values indicate about the care being taken up while preparing the drug for commerce and extractive values possibly will be useful for selection of solvents for extraction. The tests which are normally performed include ash values, extractive values, moisture content, density, viscosity, surface tension, optical rotation, congealing point, volatile content, refractive index, solubility, swelling factor, etc.

We use IP, USP/NF, EP, JP, BP, AOAC and ACS compendia methods for raw material and final product testing.
                                                                                                                                                                          

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Phytochemical analysis : The activity of any herb is dependent on the class of phytoconstituents or specific phytoconstituents being present in it. In majority of the herbals which are in use the knowledge about these is fairly known. Therefore it is necessary to devise method of standardization based upon the presence of these chemicals. These chemicals are broadly categorized into two groups’ viz. Product of primary metabolites (carbohydrates, lipids, proteins, etc.) and secondary metabolites (alkaloids, glycosides, saponins, flavanoids, coumarins, terpenoids, tannins, etc.). Our phytochemical laboratory is well equipped to undertake both qualitative and quantitative evaluation of these constituents either as class or individual.

THS Laboratory test's botanical/herbal/nutraceutical products with widely accepted methods including those recommended by Indian Pharmacopeia, Indian Herbal Pharmacopeia, United States Pharmacopeia (USP), Herbal Compendium, China Pharmacopoeia, or other professional scientific organizations, or "in-House" methods to match your new discoveries of herbs or herbal extracts.

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Testing and standardisation of herbal medicines

Quality Control Services


  • Standardization and Control of Herbal Actives.
  • Testing and Control of Impurities: Foreign matter, adulterants, Physico-Chemical analysis, Heavy Metals, Pesticides, Residual Solvents, Alfatoxins, Microbial limits, etc.
  • Isolation and purification of marker compounds.
  • Ingredient Standardization and Testing.
  • Formulation Standardization as per EMEA guidelines.
  • Battery of tests applied ranging from simple chemical assays to Chromatographic Analysis.
  • Method Development for Stability Studies and Pharmacokinetic Studies.
  • Trouble-shooting for Polyherbal Formulations.
  • Impurity profiling and characterization.
  • Accelerated Stability studies according to ICH and other regulatory requirements.
  • Preparation of Chemistry, Manufacturing and Controls (CMC) Dossier.
  • Bioanalytical Method Development.
  • Quantitative analysis of ingredients in the formulation without using marker compounds.
  • Nutritional analysis to label the food supplements.
  • Preservative testing in formulations.                                                                                                   
 

Method Development and Validation : Our professional scientists have extensive experience in analytical chemistry and routinely provide method development and validation for Herbal, neutraceuticals and stability testing. Methods are validated to current USP/ICH guidelines.

The assumption that herbal medications only have beneficial effects have proven to be incorrect and the literature reports citing problems associated with herbal preparations use are increasing. Hence the evaluation of safety aspects should have priority. Most of the adverse drug reactions to phytomedicines and toxicity could be attributed mainly due to contamination or substitution of the plant material. Contaminants most likely to be found in medicinal herbs are heavy metals, microorganisms, pesticides / herbicides and radioactive isotopes. These contaminants cannot be excluded completely but may be significantly reduced by proper cultivation and harvesting. Any one of the factors - collection, preparation, dispensing, packaging and dosage can be the cause of toxicity.

Evaluation of following parameters are carried out at THS

  • Microbial analysis
  • Heavy metal analysis
  • Aflatoxins analysis
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Microbial bioburden studies Medicinal plant materials normally carry a great number of bacteria and moulds often of soil origin. Amongst a large range of bacteria and fungi from the naturally occurring microflora of herbs, aerobic spore forming bacteria frequently predominate. Current practices of harvesting, handling and production often cause additional contamination and microbial growth. Some of the pathogenic bacteria seen in plant material are Escherichia coli, Salmonella typhimurium, Pseudomonas aeruginosa,Staphylococcus aureus.

A full-fledged microbiology section exists for testing bacterial and fungal contamination of herbal material with sterile testing facilities (Laminar flow hood). Anti microbial tests and a time saving and economical bioassay method using brine shrimps for evaluating biological activity of the herbal medicines are carried out for a preliminary screening of drugs. We also undertake Preservative Challenge, Bioburden, Assays, Sterility of herbal products.

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Heavy metal analysis An essential step in plant material analysis is the determination of heavy metals. Presence of heavy metals like lead, arsenic, mercury etc. can be attributed to many causes such as environmental pollution and traces of pesticides.

Determination of heavy metals is carried out with the help of Atomic Absorption Spectrometry at THS.

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Animal studies: We at THS undertake systematic animal studies of herbal extracts and formulations by utilizing appropriate models.

Toxicity Recent adverse events have clearly shown that all Herbal products are not free from side effects and toxicity. Products that have been confirmed to have bioefficacy can then be taken up for safety studies to determine possible side effects, adverse reactions and the maximum tolerable dosages. We undertake acute, sub-acute and chronic toxicity studies in animals.

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