Stability testing is necessary to ensure the product is of acceptable quality throughout its entire storage period. In order to do this, it is necessary to monitor compliance of the product with a suitable quality specification throughout the shelf life. It is not acceptable to only test at the time of expiry, for example, on a retention sample (even though the results of this type of testing may provide useful information about the overall stability of the product).

[ Top ]

Unlike synthetic chemicals herbal raw material can not be produced in factories. They have to be obtained from the field/ natural habitat. As the availability of crude drug is nature dependent there are more chances of getting spurious or adulterated herbs therefore the authentication of raw material is of great importance. The proper authentication of herbal raw materials is critically important to the efficacy and safety of herbal medicines.

[ Top ]

Herb authentication is a quality assurance process that ensures the correct plant species and plant parts are used as raw materials for herbal medicines. We carry out Identification and authentication of botanicals, medicinal plans and raw herbs by taxonomy, morphology, macroscopic, microscopic, histochemical, chemical and chromatographic techniques (HPTLC, HPLC).

[ Top ]

Compared with conventional preparation herbal products present a number of unique problems when quality aspects are considered. These arise because of the nature of the herbal ingredients. Which are complex mixture of constituents, and it is well documented that levels of plant constituents can vary considerably depending on the environmental and genetic factors. Furthermore the constituents responsible for the claimed therapeutic effects are frequently unknown or only partly explained. The position is further complicated by the traditional practice of using combinations of herbal ingredients. The reason to standardize herbal extract and herbal product, is to ensure that all herbal products contain the same amount of a plant's biologically active compounds--the compounds that are believed to have therapeutic effects. This is essential because the levels of plants' active compounds fluctuate wildly.

[ Top ]

Since last one decade world has seen tremendous growth in herbal drug market, which has resulted in development of numerous proprietary herbal drug formulations by various manufacturers, majority of them comprising of polyherbal formulations. With the advancement of knowledge in the field of phytochemistry it has now been observed that many of these constituents present in the drug may react with each other raising the serious concern about the stability of such formulations. This is the area, which needs to be addressed in order to determine the efficacy of the formulation. Stability testing is carried out in order to guiding formulation development, selecting packaging materials, defining expiration dating, provide evidence on how the quality of active substance or finished product varies with time under the influence of variety of environmental factors.

[ Top ]

'Standardised Extracts' are herbal preparations adjusted within an acceptable tolerance to a given content of marker constituents; standardisation is achieved by adjustment of the herbal preparations with inert material or by blending batches of herbal preparations. Standardized extracts adjusted to a defined range of marker constituents. Where as in regular extracts there is no such data available on the range as well as concentration of the marker constituents.

[ Top ]

People believe generally that herbal and natural products are safer than the synthetic or modern medicines but several cases of adverse effects of herbal drugs have been reported in developed countries during the last few years, which are allegedly caused by taking herbal products or traditional medicines. Herbal products may be contaminated with excessive banned pesticides, microbial contaminants, heavy metals and chemical toxins which cause various deformities like congenital paralysis, sensori-neural defects, liver and kidney damage etc. Thus herbal medicine has led the concerns relating to its safety, quality and effectiveness specially for 'bhasmas' as these are usually made of heavy metals like arsenic, mercury, copper, zinc, gold and silver. Therefore, contamination of herbal drugs with heavy metals is of prime concern. Recently a study conducted by Harvard Medical School on Indian ayurvedic medicines, published in the Journal of American Medical Association (JAMA) reported that ayurvedic medicines bought from 30 South Asian stores in the Boston area had potentially harmful levels of lead, mercury and arsenic. Therefore it is necessary to determine the heavy metals and mycotoxin in herbal products.

[ Top ]