Ashwagandha Capsule Development: A Worked Example From Brief to Stability-Ready Specification
PhD (Food Science) · Director of New Product Development, Food Research Lab
✓ Technically reviewed by FRL Editorial · Last reviewed: 3 November 2026 · Next review: February 2027
3 November 2026
Last checked
3 November 2026
Reading time
10 min
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14
- Worked example, not client data: a once-daily 240 mg ashwagandha root-extract capsule for India.
- The 240 mg trial dose belongs to one extract (Shoden, 35% withanolide glycosides), which its maker describes as root and leaf.
- FSSAI’s 16 April 2026 advisory permits roots only; the Karnataka High Court stay covers only the petitioners.
- HPLC/HPTLC measures strength and DNA barcoding confirms species; the file needs both.
- Six stages fix the extract, methods, dose, capsule fill, stability and route before the first batch.
About this worked example
This is a worked example, not a client project. It shows how Food Research Lab would plan the development of a single-ingredient ashwagandha (Withania somnifera) root-extract capsule for the Indian market. The brief is typical of what brands ask for. There are no client data, test results or outcomes here; every number below comes from a cited published source or a regulator’s document.
Use it as a template for any herbal supplement: the order of decisions is the same for most single-herb extracts.
The brief
An Indian wellness brand wants an ashwagandha supplement in capsule form, made by a contract manufacturer and sold as a food supplement. Ashwagandha is one of the most requested herbs in Indian supplements, so the product has to stand apart on its specification, not on the herb’s name. A typical brief sets five conditions:
Table 1. The brief and what each condition means for development
| Condition | What it means for development |
|---|---|
| One ingredient: ashwagandha root extract, no blends | The plant part, marker and label declaration stay simple to define and test. |
| One 240 mg capsule, taken once daily | This matches the dose of a published 60-day trial, but only for the extract that trial tested. |
| General wellbeing positioning, no therapeutic claims | The food-supplement route under FSSAI depends on this wording. |
| A shelf life the brand can print on the pack | It must be supported by a stability study that tracks the declared marker, not assumed. |
| A specification the contract manufacturer can be audited against | That needs a stated extract type, drug extract ratio (DER), marker, acceptance range and validated test methods. |
Where this product usually goes wrong
The 240 mg dose belongs to one extract
The best-known trial behind a 240 mg dose, Lopresti et al. (2019), gave 60 stressed but healthy adults either placebo or 240 mg of one standardised extract, Shoden, once daily for 60 days. The extract was standardised by HPLC to 35% withanolide glycosides, about 84 mg per capsule.[1] The result belongs to that extract. It cannot be transferred to another ashwagandha extract by matching the milligrams; our Lopresti 2019 study explainer covers the trial in detail.
There is a second problem for an Indian root-only product. The trial paper calls Shoden a root extract, but its maker describes Shoden as a root and leaf extract.[1][2] A capsule restricted to root extract is therefore unlikely to be the same material as the trial product. The supplier’s dossier must confirm the plant part, and the dose needs a written bridging rationale rather than an assumed match.
Roots only, under an advisory that is being challenged
FSSAI’s advisory of 16 April 2026 states that, under Schedule IV of the Health Supplements and Nutraceuticals Regulations, 2016, only ashwagandha roots and their extracts are permitted in these product categories, and that leaves in crude, extract or any other form are not permitted.[3] It followed a Ministry of Ayush letter of 15 April 2026, which directed Ayush drug makers to use roots only and to declare the plant part on the label under Rule 161 of the Drugs Rules, 1945.[3] For a food supplement, declaring “root extract” on the label is our recommendation, because it makes the root-only position checkable.
The Karnataka High Court has stayed both documents on an interim basis, but only for the petitioners in two writ petitions (W.P. No. 14990/2026 and W.P. No. 15010/2026), as reported in May 2026.[4] Every other brand remains bound by the advisory, so this product is designed as root-only.
Substitution risk
A DNA barcoding study of 107 single-drug herbal powders bought in Tamil Nadu markets found 49 (46%) adulterated, many with unrelated species.[5] Supplier paperwork alone is not enough evidence of identity.
Powder behaviour
Dry plant extracts often flow poorly, so capsule fill weight can drift even when the marker assay is clean. In one study, an unblended black pepper aqueous extract had a Hausner ratio of 1.54, which the authors classed as very poor flow; adding diluents and glidants improved it.[6] Ashwagandha extract has to be measured on the actual lot, not assumed to behave the same way.
The claim boundary
A food supplement cannot be sold with disease or treatment claims. Wording that implies treatment pushes a product towards drug regulation, so the claim has to be fixed before the formula and label.[12] Our guide to the FSSAI nutraceutical regulations sets out the categories and labelling rules.
The six-stage development programme
FRL plans a product like this as six linked stages, each with a defined output.
Table 2. Development programme
| Stage | What FRL does | Basis |
|---|---|---|
| 1. Extract specification | Root only; extract type (standardised or quantified), DER, withanolide marker and acceptance range; review of the supplier’s certificate and dossier, including plant part | EMA herbal quality guideline[8]; FSSAI advisory[3] |
| 2. Identity and strength | HPTLC fingerprint and HPLC marker assay, validated for specificity, range, accuracy and precision; DNA barcoding where suitable | ICH Q2(R2)[9]; Mück et al., 2024[7] |
| 3. Dose | Compare the chosen extract with the trial extract (plant part, solvent, marker content) and document a bridging rationale before fixing 240 mg | Lopresti et al., 2019[1] |
| 4. Capsule fill | Measure bulk and tapped density and flow on the real lot; add only the excipients needed; select capsule size | Monton and Suksaeree, 2025[6] |
| 5. Stability | Accelerated study at 40 °C and 75% RH (0, 2, 4 and 6 months) plus real-time testing to the intended shelf life | Dorni et al., 2023[10] |
| 6. Route and label | FSSAI health-supplement route; general wellbeing wording reviewed by a regulatory adviser; root declared; central licence for the manufacturer | FSSAI, 2021[11]; Takle and Mahajan, 2026[12] |
Strength and species are different questions. HPLC or HPTLC measures how much marker is present; DNA barcoding confirms which plant the material came from but says nothing about strength. A tiered approach that combines chromatographic profiling with DNA methods gives more insight than either alone.[7] The licence route itself is compared in our AYUSH licence vs FSSAI explainer.
What the programme fixes before the first batch
The output is a development file with decisions and limits fixed in advance. It is not a market claim and not a test result.
Table 3. Acceptance criteria the programme sets
| Parameter | Criterion | Basis |
|---|---|---|
| Plant part | Root only, confirmed in the supplier dossier and declared on the label | FSSAI advisory[3] |
| Marker at release | Declared value ±5%, widened to ±10% only if justified | EMA guideline, used as a benchmark[8] |
| Method validation | Specificity, range, accuracy and precision shown for each method | ICH Q2(R2)[9] |
| Stability design | 40 °C and 75% RH at 0, 2, 4 and 6 months; shelf life projected with a 10% degradation threshold, then confirmed in real time | Dorni et al., 2023[10] |
| Claim | General wellbeing wording only, reviewed by a regulatory adviser | Takle and Mahajan, 2026[12] |
The ±5% and ±10% limits come from the European Medicines Agency’s guideline for herbal medicinal products, which applies them to markers at release and over shelf life.[8] Indian food supplements are not bound by it, but it is a well-defined benchmark to write into a supplier specification.
Table 4. Deliverables
| Deliverable | What it fixes |
|---|---|
| Extract specification sheet | Plant part, extract type, DER, marker and acceptance range the supplier must meet |
| Method package | Validated HPTLC and HPLC methods, with DNA identity checks where suitable |
| Dose and capsule record | 240 mg bridging rationale, flow data, fill weight and capsule size |
| Stability protocol | Conditions, time points and limits agreed before the first batch |
| Route and claims memo | FSSAI route, root declaration, and wording to use and avoid, for adviser sign-off |
The decisions that usually cause rework (extract, dose evidence, plant part and claim) are made before the first commercial batch, and the contract manufacturer receives a specification and test methods it can be audited against.
Safety: what the file must address
Ashwagandha’s safety record is debated, and a development file should say so rather than assume it away. The Ministry of Ayush cited possible safety concerns with leaves, linked to higher levels of reactive withanolides such as withaferin A, when it restricted products to roots.[3] The Danish Veterinary and Food Administration decided to ban ashwagandha on the basis of a 2020 risk assessment from the Technical University of Denmark, a decision Indian researchers have disputed.[13] The US LiverTox database records cases of clinically apparent liver injury, usually appearing within 2 to 12 weeks of starting and usually resolving after stopping.[14] In the 60-day Lopresti trial, all 60 participants completed and no adverse events were reported.[1]
In practice, the file includes a safety literature review for the chosen extract, cautionary label wording agreed with the regulatory adviser, and no health or therapeutic claims. For a wider view of toxicology in Ayurvedic products, see our Ayurvedic nutraceutical safety guide.
Key learnings
- A dose is evidence for one extract. Write the extract into the specification. The 240 mg once-daily, 60-day trial dose applies to the extract tested;[1] a different extract, or a root-only version, needs a documented bridging rationale.
- HPLC answers strength; DNA answers species. Plan both, because neither replaces the other.
- Fix the claim and route before the formula. The plant part and the label wording depend on them, and FSSAI’s April 2026 advisory permits roots only.[3]
- Measure the powder, not just the marker, before choosing the capsule size. Plant extracts can flow very poorly.[6]
What happens next, before launch
- Run the accelerated stability study and release the first pilot batch against the agreed specification. One published herbal supplement study used 40 °C and 75% relative humidity with testing at 0, 2, 4 and 6 months.[10]
- Extend real-time testing to the full intended shelf life, keeping the marker within the agreed range (±5%, or ±10% if justified).[8]
- Re-check the status of the ashwagandha advisory and the Karnataka High Court proceedings before launch. The interim stay reported in May 2026 covered only the petitioners.[4]
A measured FRL stability project
For real stability data on a plant-extract product, see FRL’s purple tea beverage project. Over a 90-day storage study, total polyphenols fell by about 5–6% (878 to 831 mg GAE/L in the Mixed Berry variant, 845 to 796 mg GAE/L in Citrus), while anthocyanins fell by about 12–13% (55.3 to 48.6 mg/L and 48.6 to 42.5 mg/L). Anthocyanins were the most vulnerable component, which is why a specification should track a named marker, not only a total.
For brands & formulators
The same order applies to any herbal product: extract, dose, form, stability, route. Each step has a measurable limit, so the finished specification can be audited batch by batch. FRL’s herbal formulation services cover extract specification, capsule and oral solid dosage development and shelf-life studies, and our regulatory and scientific research team reviews the route and claims. When the specification is ready, our herbal pilot and contract manufacturing team can take it to scale.
For common questions on DER, marker tolerance and identity testing, read the herbal product development Q&A.
In this series
- Herbal product development process: the pillar guide: seven stages from claim to launch.
- AYUSH licence vs FSSAI: which regulatory route a herbal product takes in India.
- Standardised extract, HPLC and DNA testing: how to prove identity and strength.
- The ashwagandha stress study (Lopresti 2019) explained: what one trial does and does not support.
- Ashwagandha capsule development: a worked example (this page): You are here.
- Private-label herbal supplements in India: stock formulas versus your own.
- Herbal product development in India: 10 questions: short answers on extracts, testing, stability and regulation.
- Herbal formulation development service: work with our team on your product.
- ✓Name the extract in your specification: plant part, solvent, DER, marker and range.
- ✓Ask the supplier for the plant part in writing; a root-only product cannot rely on a root-and-leaf trial extract without a bridging rationale.
- ✓Validate both an HPLC/HPTLC assay and a DNA identity check before approving a supplier.
- ✓Measure flow and density on the real lot before you choose a capsule size.
- ✓Fix the claim wording and route first, and re-check the ashwagandha advisory and court case before launch. See AYUSH licence vs FSSAI.
Is 240 mg of any ashwagandha extract the same as the dose in the Lopresti trial?
Can ashwagandha leaves be used in a food supplement in India?
Not under FSSAI’s advisory of 16 April 2026, which permits only roots and root extracts in health supplements and nutraceuticals.[3] The Karnataka High Court’s interim stay covers only the petitioners in two writ petitions,[4] so other brands should formulate with roots only and check the case status before launch.
Does DNA barcoding confirm the strength of an ashwagandha extract?
How is the shelf life of a herbal capsule set?
With a stability study that tracks the declared marker. A common design is accelerated storage at 40 °C and 75% RH with testing at 0, 2, 4 and 6 months, projecting shelf life from a 10% degradation limit,[10] then confirming it in real time.
- Lopresti, A. L., Smith, S. J., Malvi, H., & Kodgule, R. (2019). An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine, 98(37), e17186. https://doi.org/10.1097/MD.0000000000017186 (cited for the 240 mg once-daily, 60-day design, Shoden extract, 35% withanolide glycosides, 60 participants and no adverse events).
- Sherman, A. (2026, September 8). Arjuna publishes ashwagandha safety study, highlights weight of clinical validation. NutraIngredients. https://www.nutraingredients.com/Article/2026/09/08/arjuna-publishes-ashwagandha-safety-study-highlights-weight-of-clinical-validation/ (cited for the manufacturer’s description of Shoden as a root and leaf extract).
- Food Safety and Standards Authority of India. (2026, April 16). Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in crude or extract or any other form in food products (F. No. RCD-15001/11/2021-Regulatory-FSSAI), enclosing Ministry of Ayush letter T-13020/4/2022-DCC-Part(2) of 15 April 2026. https://fssai.gov.in/upload/advisories/2026/04/ (cited for the roots-only rule under Schedule IV of the 2016 regulations, the Ayush roots-only direction, Rule 161 plant-part labelling for Ayush drugs, and the leaf safety rationale).
- LiveLaw. (2026, May 19). Karnataka High Court stays FSSAI advisory restricting use of ashwagandha leaves in health supplements. https://www.livelaw.in/high-court/karnataka-high-court/karnataka-high-court-stays-centre-advisory-ashwagandha-leaves-nutraceuticals-534813 (cited for the interim stay limited to the petitioners in W.P. No. 14990/2026 and W.P. No. 15010/2026).
- Balaji, R., & Parani, M. (2022). DNA barcoding of the market samples of single-drug herbal powders reveals adulteration with taxonomically unrelated plant species. Diversity, 14(6), 495. https://doi.org/10.3390/d14060495 (cited for 49 of 107 market samples adulterated).
- Monton, C., & Suksaeree, J. (2025). Understanding the effect of diluents on powder flow and tablet properties of poorly compressible black pepper extract using mixture design approach. International Journal of Food Science, 2025, 8655112. https://doi.org/10.1155/ijfo/8655112 (cited for the Hausner ratio of 1.54 for unblended black pepper extract and improved flow with diluents).
- Mück, F., Scotti, F., Mauvisseau, Q., Thorbek, B. L. G., Wangensteen, H., & de Boer, H. J. (2024). Three-tiered authentication of herbal traditional Chinese medicine ingredients used in women’s health provides progressive qualitative and quantitative insight. Frontiers in Pharmacology, 15, 1353434. https://doi.org/10.3389/fphar.2024.1353434 (cited for combining HPTLC profiling with DNA methods for authentication).
- European Medicines Agency. (2022). Guideline on quality of herbal medicinal products/traditional herbal medicinal products (EMA/HMPC/CHMP/CVMP/201116/2005 Rev. 3). https://www.ema.europa.eu/en/documents/scientific-guideline/final-guideline-quality-herbal-medicinal-productstraditional-herbal-medicinal-products-revision-3_en.pdf (cited for marker limits of ±5%, widened to ±10% if justified, and for extract types and DER).
- International Council for Harmonisation. (2023). ICH Q2(R2) guideline on validation of analytical procedures (EMA/CHMP/ICH/82072/2006, Step 5). European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q2r2-guideline-validation-analytical-procedures-step-5-revision-2_en.pdf (cited for validation of specificity, range, accuracy and precision).
- Dorni, A. I. C., Venkatesan, U., Srinivasan, R., Moorthy, S., & Raja, K. (2023). Evaluation of stability and determination of shelf life of an herbal food supplement: Naturovita. Journal of Pharmacognosy and Phytochemistry, 12(1), 219–225. https://doi.org/10.22271/phyto.2023.v12.i1c.14580 (cited for 40 °C/75% RH at 0, 2, 4 and 6 months and the 10% degradation threshold).
- Food Safety and Standards Authority of India. (2021). Order: Food businesses manufacturing products covered under the Health Supplements, Nutraceuticals… Regulations, 2016 to be covered under the purview of Central Licensing Authorities (File No. 15(31)2020/FoSCoS/RCD/FSSAI; revised 1 November 2021). https://www.fssai.gov.in/upload/advisories/2021/11/617f7648ce58aOrder_Nutra_License_16_09_2021_Revised_01_11_2021.pdf (cited for central licensing of nutraceutical manufacturers irrespective of turnover).
- Takle, S. P., & Mahajan, U. (2026). Regulatory landscape of nutraceuticals in India: Current status, challenges, and a roadmap for harmonization. International Journal of Pharmaceutical Sciences. https://doi.org/10.5281/zenodo.20284587 (cited for product classification and the claims boundary between nutraceuticals and drugs).
- Patwardhan, B., Chaturvedi, S., Tillu, G., Deshpande, S., & Hegde, B. M. (2024). Danish ban on Ashwagandha: Truth, evidence, ethics, and regulations. Journal of Ayurveda and Integrative Medicine, 15(4), 101028. https://doi.org/10.1016/j.jaim.2024.101028 (cited for the Danish ban based on the 2020 DTU report and the dispute over it).
- National Institute of Diabetes and Digestive and Kidney Diseases. (2012–). Ashwagandha. In LiverTox: Clinical and research information on drug-induced liver injury. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK548536/ (cited for reported liver injury, its typical onset and resolution).
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