Analytical 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 objective of the analytical procedure should be clearly understood since this will govern the validation characteristics which need to be evaluated. Typical validation characteristics which should be considered are listed below:

Accuracy
Precision
Repeatability
Intermediate Precision
Specificity
Detection Limit
Quantitation Limit
Linearity
Range

Each of these validation characteristics is defined in the attached Glossary. The table lists those validation characteristics regarded as the most important for the validation of different types of analytical procedures. This list should be considered typical for the analytical procedures cited but occasional exceptions should be dealt with on a case-by-case basis. It should be noted that robustness is not listed in the table but should be considered at an appropriate stage in the development of the analytical procedure.

Furthermore revalidation may be necessary in the following circumstances:
- changes in the synthesis of the drug substance;
- changes in the composition of the finished product;
- changes in the analytical procedure.

The degree of revalidation required depends on the nature of the changes. Certain other changes may require validation as well.

Toxicity : 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.

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.