Dr Amit Chandra, Distinguished Scientist – Botanical Innovation, Amway Global I&S (R&D)
In the dynamic world of ayurvedic and herbal preparations in India, maintaining botanical integrity is paramount. Purity, Safety and Potency (PSP) are crucial considerations, necessitating stricter guidelines to combat issues like adulteration and mislabelling. The post-COVID era has exacerbated these concerns due to high demand and limited supply. Let’s explore some stringent practices that can not only safeguard the integrity of botanicals, but also ensure customer satisfaction.
Scientific practices play a vital role in the seed-to-shelf transformation of herbal ingredients. It is crucial to emphasise the importance of fit-for-purpose specifications and corresponding test methods at each stage (fit-for-purpose tests). Trained experts, known as fit-for-purpose people, execute these practices to preserve botanical integrity. Following these recommendations assures consumers of consistently high-quality and safe products.
To combat economically motivated adulteration and contamination, is it essential to stress upon the significance of prioritising quality over quantity. It encourages a harmonious interplay between specifications and methods, ensuring that the final product meets stringent standards. By embracing these principles, one can uphold the integrity of botanicals and promote the well-being of consumers.
Preserving Herbal Integrity: Prioritising Purity, Safety and Potency (PSP) Principles
Stage 1 – Seed: It is crucial to verify the authenticity of botanicals, ensuring they are the correct genus and species (authenticity), and free from Genetically Modified Organisms (GMOs). To meet these requirements, fit-for-purpose methods such as DNA fingerprinting, PCR tests, and micro/macroscopic studies (imaging) are recommended, using existing reference materials as positive controls. Additionally, it is essential to guarantee the viability of seeds for germination and ensure they are free from pesticides and heavy metals within the permissible limits set by regulations, employing analytical chemistry. While the verification of the correct plant part in a seed is not within the scope of this discussion, these measures collectively contribute to upholding the integrity and quality of botanicals.
Stage 2 – Sapling: It is important to check the viability of the growth of baby plants to adults when transferred from a nursery to a larger farm for scale-up.
Stage 3 – Fresh / Dehydrated Plant Part: During commercial scale-up on the farm, a crucial stage occurs as the plant transitions from growth to adulthood. Verification of plant species and specific plant part development is essential, along with the qualitative and quantitative assessment of targeted phytonutrients.
Fit-for-purpose methods are employed for these purposes. DNA and microscopic analyses verify the authenticity and confirm GMO absence through DNA-PCR tests. Analytical chemistry screens for trace contaminants from the soil or environment.
This stage involves the development and application of methods serving two key purposes. Firstly, qualitative testing using techniques like HPTLC identifies the specific plant part of interest and verifies the presence of unique phytonutrients in it. Secondly, specific markers are selected from the chromatographic fingerprint, and accurate quantification is achieved through HPLC and/or GC for absolute quantification of the plant part.
Reference material aids qualitative testing, while commercially available standards ensure precise quantification of marker phytonutrients. This method establishes a solid foundation by serving as an identification (ID) process and quantification of the specific plant part, ensuring success in subsequent stages.
Stage 4 – Harvest optimisation: At this stage, the plant’s authenticity and its freedom from GMOs and trace contaminants need to be rigorously checked. Accurately identifying the specific plant part of interest and ensuring its active production of desired phytonutrients. The toolkit includes precise qualitative and quantitative methods for the identification and measurement of phytonutrient markers. Through meticulous monitoring, the beneficial phytonutrient levels during the plant’s growth can be optimised. Upon reaching the desired level, the plant part is harvested and transformed into a powdered and dehydrated form for extraction.
To ensure the quality of the dehydrated ingredient, comprehensive data based on legitimate test methods is imperative. These specifications validate its purity, authenticity, and safety by confirming the absence of GMOs and trace contaminants. Furthermore, the data quantifies the phytonutrient marker levels, establishing the ingredient’s potency. The rigorous testing methods uphold the highest standards of purity, safety, and potency (PSP) for the dehydrated plant ingredient.
Stage 5 – Extraction: This stage is crucial for maintaining the integrity of a botanical ingredient intended for human consumption. It involves the transition from the farm to the factory (stage 4 to stage 5), where there is a change of location and custody. It is vital to ensure full transparency and monitoring during this transition to prevent economically motivated botanical adulteration, such as spiking or fortifying the material with synthetic or other botanicals and/or phytonutrients to pass tests.
The dehydrated plant part is then extracted using certified safe solvents for food, such as ethanol, hydro-ethanol, water, SFCO2, steam distillation, or cold press, depending on the physical properties of the phytonutrients. The resulting extract can be in liquid, oil, viscous, or solid form. It is crucial to test the extract against specifications for the quality and quantity of phytonutrients it contains, using appropriate test methods. Maintaining active communication between the scale-up facility/supplier, manufacturer, and testing lab is essential to preserve botanical integrity. Additionally, ensuring traceability from stage 5 to stage 1 is mandatory at this point.
Stage 6 – Commercial grade raw material: The crude extract undergoes conversion into a commercially viable raw material ingredient suitable for manufacturing. It is blended with carriers to enhance flowability and tailored for specific delivery formats like tablets, powders, soft gels, or capsules. At this stage, the botanical raw material is accompanied by a specification, also known as a claim, which includes crucial information on its purity (authenticity and identification), safety (non-GMO and absence of trace contaminants), and potency (phytonutrient marker levels). This information is presented in the form of a “Certificate of Analysis” (CoA). The raw material must be readily available for audits and retests, employing fit-for-purpose test methods to verify compliance with the specified criteria for purity, safety, and potency (PSP). The development and testing of raw materials can be carried out by commercial suppliers (third parties), laboratories, or consumer goods manufacturing companies themselves, depending on available technologies and the expertise of scientists, engineers, farmers, and formulators.
Stage 7 – Final product: The formulated product can consist of one or more botanical raw materials blended together to create various delivery forms such as tablets, capsules, soft gels, gels, and powders. These products are then packaged and made available for sale, complete with label claims and expiration dates. The label claim provides qualitative and quantitative information about the contents of the product, while the expiration date indicates its stability and sell-by date. Additionally, the product is assigned a lot number, adhering to the regulations of the country where it is being sold. Both the label claim and expiration date are considered fit-for-purpose specifications, ensuring that the product meets the necessary standards. It is essential to employ fit-for-purpose methods to verify these specifications before the product is released for sale.
Key to success: PSP meets herbal integrity
Achieving full control over purity, safety, and potency (PSP) from the seed to the shelf is the cornerstone of the commitment to excellence. By meticulously ensuring the authenticity of ingredients and utilising the correct plant parts, unwavering purity is maintained. Rigorous measures guarantee that the products are free from GMOs and trace contaminants, instilling confidence in their safety. Open communication along the supply chain, between manufacturers and testing labs, ensures transparency. The expert team in phytochemistry, horticulture, soil science, and biology drives success. Routine audits, meticulous documentation, and fit-for-purpose methods align with the specifications and claims. This approach, also known as ‘quality by design’ (QbD), emphasises proactive product development based on sound science and risk management.
Above all, the unwavering focus is on consumer safety. It is understood that those who rely on these products place their trust in us, seeking the health benefits they expect and deserve. It is therefore our responsibility to deliver nothing short of the best.