A question of quality, are you buying the right herbal extracts?

Dolcas Botanosys, continuing its efforts to reach out and educate its clients, recently conducted a survey of over 135 companies of various sizes in the herbal and ayurvedic industry. We wanted to know if these companies really knew what they were buying and the extent of their involvement in understanding the science behind the herbal extracts and ingredients they bought worth crores, and in turn fed to the final customer.

The results were startling. Almost 68% of the companies explicitly believed the suppliers’ claims and rarely tested the material. Of the 32% who did have a regular quality control in place to check incoming material, more than half did not test for material authenticity. Further, many of these had non-validated Methods of Analysis, raising doubts on the results itself. Only about 10-11% of the participant companies routinely conducted all the tests required on a typical Certificate of Analysis (CoA).

We immediately decided we had to right (and rewrite) the situation. The result is this brief informative about some common aspects where unscrupulous herbal extract suppliers pass off cheap, poor quality material which undoubtedly severely impacts your product quality. We have also recently published the Thin Layer Chromatography Handbook of the Indian Botanicals and distributed free of cost to the industry.

Dolcas Botanosys is shortly scaling up its unit into a state-of-the-art USFDA, cGMP compliant manufacturing plant replete with cutting-edge tools and R&D Centre to take Herbal Science to the next level. We invite your Quality and Purchase Departments to partner with us in developing transparent methodologies and robust foolproof systems to ensure good efficacious products reach the final consumer.

Identity and Authenticity of Herb

A very common vice. Manufacturers use an altogether different herb to pass off as the original one or adulterate partially with another extract/material that mimics the genuine one . The extract of both herbs looks the same in organoleptic and physical parameters, making it difficult for the client to judge.

Common examples: .

Triphala extract is adulterated with extract of Majuphal, or is disproportionately comprised of Harir and Baheda (which are cheaper than Amla) to give a higher assay in Tannin assay.

Shatavari extract is adulterated with Tribulus and Fenugreek and bring down the cost to a fraction.

Withania somnifera extract (mentioned as root extract) is more often than not, extract of the leaves of withania (Ashwagandha), the genuine ‘root only’ extract costs many times more than the whole-plant extract.

Protodioscin from Fenugreek seed is used to adulterate in Tribulus extract as Indian tribulus does not contain this compound.

The Solution: Thin Layer Chromatography (TLC) is a very quick, easy and cheap method of identification which is also universally acceptable. Pharmacopoeial methods are available and will ensure you indent the genuine herb extract only.

Synthetic Adulterants

In an attempt to offer cheap (and sometimes impossibly high active contents), some manufacturers adulterate their extracts with the synthetic compound of the naturally found actives or other compounds which fool the test method.

Common examples:

Synthetic Curcumin is adulterated into natural Turmeric extract to bring down the cost significantly

Boswellia extract is adulterated with synthetic resin, or citric acid to give a false positive in Boswellic Organic Acid assays.

Synthetic Berberine HCl is dosed in Berberis extract to raise it to 95% or more.

Synthetic Levo-Dopa is adulterated into Mucuna extract to raise to naturally unfeasible 90% range.

The Solution: Ask your supplier to furnish a ‘100% Natural’ or ‘genuine herb source’ certificate on his letterhead which may be subject to legal pursuance. Further, Carbon-14 dating test can also be done randomly in case the qualities are large or you have doubts over the integrity of the supplier. Further, a ‘proportion analysis’ of the other compounds in the extract when made from genuine material will reveal if any ‘outside’ material has been used to spike.

Ratio extract

The biggest misnomer in the herbal extracts industry to date! In our survey, we found a surprisingly high number of companies still buying their extracts based on ratios.

Ratios were actually developed almost a century ago as rough measures for self audit and costing purposes. Somehow they crept into commercial dealings and now companies offer 5:1, 10:1 or even 30:1 extracts. The problem with ratio extracts is that it does not indicate standardization to any active content/ chemical marker. For example, the solvent extracted 5:1 of a herb will differ entirely from the aqueous 5:1 of the same herb.

Thus, there is no way of looking at an extract and concluding if it was really made as claimed 5:1 or 10:1. In one particular incident, we tested the material from a supplier and found they sold the exact same Tribulus extract 7:1 to one client and to another client as 10:1 for double the price. Obviously, someone was being cheated!

Examples:

Ashwagandha 5:1 should ideally be Withanolides > 8% but is usually found to contain only 1.5-2%

Amla 4:1 should ideally be Tannins > 45% but is usually found to contain only 25-30%

Cissus 10:1 should ideally contain 3-Ketosterones >5% but we found the material of all manufactuers contains only 1.5-2%

Tribulus 10:1 should ideally contain Saponins >50% but most manufactuers only sell upto 40% in this grade.

The Solution:

Buy extracts based on the active compound/chemical marker tested by validated methods (HPLC, UV-Spectro, Gravimetric, Titrimetric etc) and not on ratios. Methods of Analysis are available in Pharmacopoeias, reputed scientific journals and recognized books books in the industry. This will help your Purchase Department make a decisive apple to apple comparision between two suppliers.

Active Ingredient

Phytochemical science has progressed rapidly since last 2-3 decades and now the actives of almost all major commercial herbs are well known. Given the way the international markets are moving, it is now time to standardize our products based on marker compounds or active compounds as identified by advanced techniques like HPLC, GC, HPTLC etc.

Examples

Bacopa 50% Saponins (by Gravi) will be much cheaper than Bacosides 50% (by HPLC)

Ashwagandha 5% Withanolides (by Gravi) will be much cheaper than Withanolides 5% (HPLC)

Boswellia Organic Acids 65% (by titration) will test less than 30% when tested by HPLC.

The Solution

While using standardization techniques like UV-Spectro, Gravimetry and Titrimetry will also provide reasonable quality control, your attempt should be to buy products based on HPLC marker compounds. The higher price will not effect your formulation cost, as a significantly lesser quantity will be needed and product efficacy will be far more enhanced.

Testing Method

It was surprising to note how many versions of a test method we came across during our survey. Some manufacturers of extracts deliberately change or shorten the steps in a test method to enable their material to pass the control grade.

Some common examples where methods are fiddled with:

Saponins by gravimetry, MoAs of some manufactuers were missing some crucial steps

Gymnemic Acid by gravimetry. MoA did not highlight the pH adjustment and drying precautions to be taken.

Bacopa by HPLC. Additional non-Bacoside peaks were being added to increase the result.

The Solution:

Ask your extract supplier to stick to Pharmacopoeial methods or standard industry acceptable/scientifically developed methods. In-case your supplier insists that his ‘In-House’ method is correct, ask them to match it with the results from a validated method from any independent NABL/DST laboratory.