Why Herbal Standardisation Matters: A Guide for Consumers and Product Developers
- Jun 11, 2025
- 4 min read
Updated: Jun 16, 2025
Herbal medicine has a long and rich history, from traditional remedies passed down through generations to today’s clinically studied supplements. But as the wellness industry grows, so does the need for consistency, quality, and scientific backing. That’s where herbal extract standardisation comes in.
Whether you're a health-conscious consumer or a product formulation specialist, understanding what herbal standardisation is and why it matters can help you choose, or create, better, more effective products. In Australia, this is especially important as the Therapeutic Goods Administration (TGA) strictly regulates herbal ingredients to ensure safety, efficacy, and quality.
What are herbal extracts?
Herbal extracts are concentrated preparations made from a plant’s parts such as roots, leaves, bark, berries, or flowers. The goal of an extract is to isolate the key constituents (the “actives”) responsible for the plant’s effects.
For example:
Echinacea extract may be derived from the aerial parts (leaves and stems) or the root, each offering different phytochemical profiles.
Turmeric extract is often valued for its curcuminoids, compounds responsible for its vibrant colour and anti-inflammatory potential.
These extracts can vary greatly in strength depending on the plant part used, the extraction method (water, ethanol, etc), and the plant’s growing conditions. This is where standardisation plays a critical role.
What is Herbal Extract Standardisation?
Standardisation means adjusting the extract so that it consistently contains a specified amount of one or more active compounds. Think of it as quality control at the molecular level.
A few common examples:
A standardised Ginkgo biloba extract might be labelled as “standardised to Ginkgo flavonglycosides [X mg]”
Milk thistle might be “standardised to contain flavanolignans calculated as silybin [X mg]” the key antioxidant compound.
Turmeric could be “standardised to 95% curcuminoids.”
These numbers tell you that the extract has been tested and adjusted to ensure consistent potency, something that’s critical when you're relying on the product to deliver a specific health benefit.
How to read if an ingredient is standardised
On a raw material specification sheet or product label, look for language like:
“Standardised to [X]% [compound]”
“Extract ratio: 10:1, standardised to [compound]”
“Derived from [plant part], extracted using [solvent], standardised to [compound]”
For example: "Green tea extract (Camellia sinensis) leaf, standardised to 50% EGCG" tells you:
The part used: leaf
The key compound: EGCG (epigallocatechin gallate)
The percentage: 50% of the extract’s weight is EGCG
For formulation specialists, this info is critical to dose accurately and match clinical research.
Methods of standardisation
There are several ways to standardise herbal extracts:
Physical adjustment: blending multiple batches to reach a consistent active concentration and marker levels.
Selective extraction: using specific solvents and conditions to pull out only the desired compounds within the boundaries of the herbal matrix.
Use of excipients (within certain limits): for stabilisation or standardisation purposes, but not to artificially boost active content.
Each method must adhere to Good Manufacturing Practice (GMP) and must be validated by analytical techniques like HPLC (High Performance Liquid Chromatography), UV spectrophotometry, or mass spectrometry—ensuring that what’s on the label is what’s in the bottle.
A note on standardisation methods, what’s not allowed: A standardised herbal extract must reflect the natural profile of the plant material from which it is derived. Issues of ‘adulteration’ arise when active compounds are added by suppliers post-extraction and results in a product that no longer reflects the original herbal source. This is not permitted by the TGA and is not acceptable for listed complementary medicines. This is why it is vitally important to obtain standardised raw materials from reputable suppliers with transparent manufacturing processes.
Why standardisation is so important
1. Consistency across batches
Plants vary by season, region, and even weather. Standardisation smooths out those variables so every batch delivers the same efficacy.
2. Alignment with clinical studies
Most clinical research on herbal products is conducted using standardised extracts. If a trial used milk thistle extract with 80% silymarin and your product only delivers 30%, it’s unlikely to provide the same benefits and therefore cannot leverage that research to support indications. This is why matching the plant part, extraction method, and active content is crucial.
3. Regulatory compliance
In Australia, the TGA requires that listed complementary medicines (e.g., herbal supplements) meet quality and safety standards. Using standardised extracts makes it easier to comply with TGA rules and submit necessary documentation during listing or evaluation.
4. Improved formulation precision
For product developers, knowing the precise content of an active compound helps with accurate dosing and synergy between ingredients, reducing the risk of under- or over-delivery. Additionally, the act of standardising an ingredient can be important for obtaining the desired therapeutic effect in the end product. For example, fenugreek can be standardised to specific glycosides for mens health products, whereas it can be standardised to 4-HI (4-Hydroxyisoleucine) for sports nutrition/pre-workout formulations.
The competitive edge
In a crowded market, formulations that use standardised herbal extracts stand out. They can make stronger, evidence-based claims, build consumer trust, and deliver real results that align with research outcomes.
From a branding standpoint, having well-standardised ingredients allows you to:
Promote clinically backed efficacy
Offer transparent labelling
Justify premium pricing
A summary on standardisation
Herbal extract standardisation isn’t just a technical process, it’s a promise of consistency, safety, and efficacy. For consumers, it means confidence in the product. For product developers, it’s the foundation for building high-quality, compliant, and effective supplements.
As the TGA continues to raise the bar for herbal medicine in Australia, understanding and embracing standardisation will not only help you stay compliant, it will set your products apart in a discerning market.
Want to learn more about herbal standardisation or see how to incorporate it into your formulations?
Connect with our team of regulatory and product development experts for support on creating TGA-compliant, evidence-based herbal products.
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