Nigella Sativa Extract

What makes Nigella Sativa Extract commercially compelling today is not the mythology - it is the molecule behind it.
Thymoquinone (TQ) is the primary bioactive constituent of Nigella sativa seed, and it has generated one of the most prolific pharmacological research profiles of any single plant-derived compound in the past two decades. A search of PubMed returns over 2,000 published studies referencing thymoquinone - covering anti-inflammatory mechanisms, immunomodulatory activity, antioxidant pathways, metabolic support, and antimicrobial properties. That volume of peer-reviewed attention is not coincidental. It reflects a compound with genuine, mechanism-linked biological activity across multiple physiological systems.

Jiuyuan Biotechnology is a leading manufacturer and supplier of high-quality Nigella Sativa Extract. Located in Xi'an, China, we specialize in providing natural plant extracts and fruit & vegetable powders. Our Nigella Sativa Extract is derived from the seeds of the Nigella sativa plant, commonly known as black seed or black cumin. The extract is produced through a rigorous, state-of-the-art process to ensure maximum potency and purity. With our advanced production capabilities, we offer a product that is ideal for the health food, functional food, and cosmetics industries. 

Standard Grades Available

Full Technical Panel - Powder

Full Technical Panel - Oil

All specifications comply with our internal quality control standards. Third-party verification reports are available on request. Contact info@jiuybiotech.com for custom TQ concentration grades or oil-format inquiries.

Thymoquinone is a volatile, lipophilic compound sensitive to heat, light, and oxidation. Every stage of our dual-format production process - powder and oil - is engineered around protecting it.

Powder Production Process

Our powder extraction follows a validated, GMP-aligned workflow with defined critical control points (CCPs) at extraction, quality testing, and purification stages.

Stage 1 - Raw Material Selection & Sorting Incoming Nigella sativa seeds are hand-sorted to remove foreign matter, damaged seeds, and extraneous plant material. Accepted lots undergo:

Macroscopic and microscopic botanical identity verification

TLC fingerprint comparison against authenticated N. sativa reference material

Aflatoxin screening (B1, B2, G1, G2) - mandatory for every lot

Pesticide multi-residue screening by GC-MS / LC-MS

Heavy metals analysis by ICP-MS (per GB 5009 series methods)

Moisture and ash content measurement

Stage 2 - Extraction (Critical Control Point)

Solvent: food-grade ethanol and purified water at optimized ratio

Temperature: controlled below 45°C to minimize TQ volatilization and degradation

Light-excluded extraction vessels throughout

2–3 extraction cycles to maximize TQ yield

Stage 3 - Solid-Liquid Separation Spent plant material is separated from the crude extract by filtration. Filtrate proceeds to concentration.

Stage 4 - Concentration Extract liquid is concentrated under reduced pressure (vacuum evaporation) at controlled temperature to protect TQ integrity.

Stage 5 - Purification (Critical Control Point) The concentrated extract undergoes a purification step to remove pigments, waxes, and non-target matrix compounds. Purification protocol is calibrated to the target TQ concentration grade.

Stage 6 - Drying Purified concentrate is spray dried under controlled inlet temperature parameters. Inlet temperature is maintained at the minimum effective level to protect TQ.

Stage 7 - Milling and Sieving Dried extract is milled and sieved to achieve 95% passage through 80 mesh.

Stage 8 - Quality Testing (Critical Control Point) Every batch undergoes full release testing - HPLC for TQ content, TLC identification, microbial panel, heavy metals, and physical parameters - before proceeding to packaging.

Stage 9 - Packaging Finished powder is packed in fiber drums (25 kg net weight) with double inner plastic bags, nitrogen-flushed, and sealed. Storage conditions: sealed, dark, ≤ 25°C, RH ≤ 40%.

Oil Production Process

The oil production follows a separate cold-press pathway designed to preserve the volatile oil fraction.

Stage 1 - Raw Material Selection & Sorting Same incoming quality protocol as powder production.

Stage 2 - Cold Press (Critical Control Point) Seeds are cold-pressed at low temperature to extract the fixed oil fraction. Cold pressing preserves TQ and the polyunsaturated fatty acid profile without thermal degradation.

Stage 3 - Static Separation Crude oil undergoes gravity separation to remove suspended solids and water.

Stage 4 - Enrichment Extraction (Critical Control Point) The oil fraction undergoes an enrichment step to concentrate TQ to the target specification (≥ 5% or ≥ 10%).

Stage 5 - Low-Temperature Solvent Removal Residual extraction solvent is removed under low-temperature vacuum conditions to protect volatile TQ content.

Stage 6 - Filtration Filtered to remove particulates and achieve the target clarity specification.

Stage 7 - Quality Testing (Critical Control Point) Full release testing including HPLC TQ quantification, TLC identification, microbial panel, and heavy metals.

Stage 8 - Packaging Finished oil is packed in plastic drums (20 kg net weight), nitrogen-flushed, and sealed. Storage conditions: sealed, dark, ≤ 25°C, RH ≤ 40%.

Nigella sativa seed contains a chemically complex array of bioactive constituents. The pharmacological profile extends well beyond thymoquinone alone - though TQ remains the primary driver of documented clinical activity.

Thymoquinone (TQ) - CAS 490-91-5

The principal bioactive and primary standardization marker. TQ is a monoterpene ketone (C₁₀H₁₂O₂, MW 164.2 g/mol) found in the volatile oil fraction of Nigella sativa seed. It is soluble in water, ethanol, and propylene glycol.

Peer-reviewed mechanisms include:

• NF-κB inhibition - TQ suppresses nuclear factor kappa B activation, reducing downstream expression of pro-inflammatory cytokines (TNF-α, IL-1β, IL-6, IL-8)
• Nrf2 pathway activation - TQ activates the Nrf2 antioxidant response element, upregulating endogenous antioxidant enzymes (superoxide dismutase, catalase, glutathione peroxidase)
• Apoptosis induction - TQ modulates the Caspase-3/Bax/Bcl-2 signaling pathway, promoting apoptosis in abnormally proliferating cell lines
• Immune modulation - TQ demonstrates both immunostimulatory effects on innate immunity and regulatory effects on Th1/Th2 balance
• Antimicrobial activity - Documented inhibitory activity against Staphylococcus aureus (including MRSA strains), Escherichia coli, Candida albicans, and respiratory pathogens
• Metabolic effects - Published studies document TQ's effects on fasting blood glucose, insulin sensitivity, and lipid profiles

Thymohydroquinone (THQ)

The reduced form of thymoquinone. THQ has demonstrated potent acetylcholinesterase inhibitory activity - relevant for cognitive health formulations. It also contributes to the extract's antimicrobial profile and serves as a secondary HPLC marker.

Thymol

A phenolic monoterpene contributing to the extract's antimicrobial and antifungal activity. Quantified by GC analysis as a tertiary authenticity marker.

Alpha-Hederin

A saponin compound with documented immunostimulatory activity in cell line models. Contributes to the extract's immune-modulating profile in ethanol-extracted grades.

Fixed Oil Fraction (Linoleic Acid, Oleic Acid)

Nigella sativa seed contains 30–40% fixed oil by weight, rich in linoleic acid (omega-6, ~55%) and oleic acid (omega-9, ~25%). In oil-grade products, these fatty acids contribute anti-inflammatory and skin-nourishing properties.

The following efficacy data is drawn directly from peer-reviewed published research. These findings represent documented pharmacological activity - not marketing claims.

1. Inhibition of Acute Myeloid Leukemia Cell Proliferation

Research published in the Chinese Journal of Experimental Hematology (2025) demonstrates that thymoquinone inhibits leukemia cell proliferation and induces cell death. The primary mechanisms involve promoting apoptosis-related protein expression, suppressing pro-proliferative signaling pathways, and downregulating genes associated with tumor malignancy.

2. Protection Against Cardiac Fibrosis

A study published in China Pharmacy (2019) shows that thymoquinone attenuates LPS-induced myocardial fibrosis in rats. TQ reduces inflammatory cytokine levels, decreases oxidative damage and collagen deposition, and downregulates fibrosis-associated gene expression.

3. Cardioprotection in Hyperlipidemia

Research published in Chinese Clinical Pharmacology and Therapeutics (2022) documents TQ's ability to reduce blood lipid and inflammatory markers in hyperlipidemic mice, attenuate myocardial inflammation and fibrosis, and regulate proteins associated with lipid deposition, antioxidant defense, and fibrosis.

4. Inhibition of Cutaneous Squamous Cell Carcinoma

A study published in Chinese Journal of Medical Aesthetics and Cosmetology (2021) demonstrates that TQ inhibits skin squamous cell carcinoma proliferation, induces apoptosis, and reduces cell migration. The mechanism involves modulating the balance between pro-apoptotic and anti-apoptotic proteins via the Caspase-3/Bax/Bcl-2 signaling pathway.

5. Attenuation of Experimental Periodontitis

Research from Shihezi University (2024) shows that TQ reduces periodontal inflammation and alveolar bone resorption in rats, lowers pro-inflammatory cytokine levels, raises anti-inflammatory and bone-protective factor levels, and demonstrates no significant toxicity to the heart, liver, or kidneys at studied doses.

These findings represent published research outcomes. They do not constitute approved health claims for finished consumer products. Formulators should consult their regulatory affairs team for claim language appropriate to their target market.

Formulation Compatibility Notes

• Capsule / softgel formats: High-potency powder grades (10%, 20%) are preferred for encapsulation. TQ has a characteristic spicy-aromatic odor - enteric coating or odor-masking encapsulation improves consumer acceptability at higher doses.
• Oil-based softgels: TQ oil grades (5%, 10%) are directly compatible with softgel fill systems. Pairs well with organic black seed oil for clean-label positioning.
• Powder blends: TQ is sensitive to oxidation in open powder blends. Use antioxidant co-formulants (mixed tocopherols, ascorbyl palmitate) and nitrogen-flushed packaging for finished products.
• Topical cosmetic formats: Oil grade preferred for cosmetic carrier compatibility. TQ content provides functional antimicrobial and anti-inflammatory activity in leave-on formulations.
• Halal market positioning: Nigella sativa carries exceptional brand equity in Muslim-majority markets globally. Halal certification from a recognized certifying body is a commercial requirement for this segment. We provide Halal certificates with every batch.
• Classical pairings: Nigella sativa pairs effectively with Boswellia serrata extract for anti-inflammatory stacks, with Pine Bark Extract (as seen in commercial products like Thymenol) for synergistic antioxidant positioning, and with Honey / Propolis extract for immune support formulas.

Nigella sativa presents two specific quality risks that distinguish it from most other botanical extracts: aflatoxin contamination and thymoquinone volatility loss during processing. Our QC system addresses both directly and systematically.

Aflatoxin Risk Management

Seeds from certain growing regions carry elevated aflatoxin risk due to pre-harvest and post-harvest fungal contamination. Aflatoxins are potent hepatotoxic and carcinogenic mycotoxins regulated at very low levels in both the EU (4 µg/kg total aflatoxins) and the US (20 ppb total aflatoxins for food).

Our aflatoxin control protocol:

• Incoming seed screening: HPLC with fluorescence detection (HPLC-FLD) or validated ELISA
• Internal rejection limit: 2 µg/kg total aflatoxins (more stringent than EU regulatory requirement)
• Finished extract re-testing before release
• Aflatoxin results reported on every COA - without exception

Thymoquinone Volatility Management

TQ is a volatile compound. Improper drying temperatures, prolonged heat exposure, or inadequate packaging cause significant TQ loss between production and formulation. We manage this through:

• Temperature-controlled extraction and concentration (below 45°C)
• Light-excluded processing vessels throughout
• Spray drying parameter optimization for TQ retention
• Nitrogen flushing and opaque packaging as standard practice
• Peroxide value monitoring to track oxidative degradation

Full QC Protocol Summary

Incoming Raw Material:

• Botanical identity: macroscopic + TLC fingerprint
• Aflatoxin: HPLC-FLD (mandatory)
• Pesticide: GC-MS / LC-MS multi-residue panel
• Heavy metals: ICP-MS per GB 5009 series
• Moisture and ash

In-Process (Critical Control Points):

• Extraction yield tracking per batch
• In-process TQ monitoring by HPLC
• Purification yield verification
• Spray drying / cold press parameter logging (continuous)

Finished Product Release:

• HPLC: thymoquinone (certified reference standard, CAS 490-91-5)
• TLC: botanical identification (positive required)
• Aflatoxin: HPLC-FLD re-test on finished extract
• Full microbial panel: TPC, yeast/mold, coliform, Salmonella, S. aureus
• Heavy metals: Pb, As, Hg, Cd (per GB 5009 series)
• Physical panel: appearance, odor, particle size, moisture, ash

Stability Program:

• Accelerated stability: 40°C / 75% RH, 6-month protocol (light-protected, nitrogen-flushed)
• Real-time stability: 25°C / 60% RH, ongoing
• TQ content tracked at each stability time point

Where Nigella Sativa Extract stands apart: No other botanical in the immune and anti-inflammatory category combines TQ's multi-mechanism pharmacological profile - spanning cardiovascular protection, metabolic support, antimicrobial activity, and apoptosis modulation - with the extraordinary brand recognition that Nigella sativa carries in halal-certified, Middle Eastern, South Asian, and Muslim-majority consumer markets. Its cross-civilizational heritage and growing peer-reviewed research base make it one of the most versatile botanical positioning stories available to formulators today.

Transparency about contraindications is part of responsible ingredient supply. The following guidance is based on published safety literature and traditional use documentation.

Contraindicated populations:

• Pregnant women
• Breastfeeding women
• Infants and young children
• Individuals with known Nigella sativa allergy
• Individuals with hypotension (low blood pressure)
• Individuals with coagulation disorders

Pre-surgical guidance:

Discontinue use at least 2 weeks before scheduled surgery due to TQ's documented effects on platelet aggregation and blood pressure.

Drug interaction caution:

Concurrent use with antihypertensive, anticoagulant, or antidiabetic medications requires medical supervision. TQ may potentiate the effects of these drug classes.

Gastrointestinal tolerance:

Excessive intake may cause gastrointestinal discomfort. Recommend taking with food at standard supplement doses.

1. Industry-Leading Production Capacity & Expertise

● 13+ years of experience in plant extract R&D and nutraceutical ingredient manufacturing

● 6 modern production workshops covering 70,000 m² and 10 automated extraction & purification lines

● Flexible purity (85% standard, 90–98% custom-grade), particle size (80–350 mesh), and custom packaging

2. Advanced Fermentation & Bio-Synthesis Capabilities

● Implements microbial fermentation and engineered bio-synthesis to produce Nervonic Acid

● Reduces seasonal raw material dependency, improving batch-to-batch consistency and bioactivity

● Supports sustainable and eco-friendly production

3. High-Quality & Batch Consistency

● Proprietary purification processes with HPLC, GC, ICP-MS, and moisture analysis

● Certificate of Analysis (COA) provided for every batch

4. Scientific R&D & Formulation Support

● 500 m² R&D center staffed with 12 scientists for formulation guidance, custom blends, and technical consultation

5. Certified & Compliant Production

● Facilities certified cGMP, FSSC 22000, ISO 22000, ISO 9001, HALAL, KOSHER

● Meets international quality standards for global markets

We offer flexible packaging options, from small-scale trial sizes (1kg) to large-scale bulk orders (up to 25kg). All products are shipped with full traceability and documentation, including Certificates of Analysis (CoA). Our global distribution network ensures timely delivery to customers worldwide, with fast shipping within 30 days of order.

You can select from a range of shipping options.

Who Sources Nigella Sativa Extract?

• Immune support supplement brands building halal-certified product lines
• Anti-inflammatory, respiratory, and cardiovascular health formula developers
• Metabolic health supplement companies targeting blood sugar and lipid management
• Hair care and scalp health product developers
• Cosmetic and personal care companies developing anti-acne or skin-soothing topicals
• Functional food companies entering the halal wellness category
• Private label brands targeting Middle Eastern, South Asian, or Muslim-majority consumer markets
• Pharmaceutical companies sourcing standardized thymoquinone (≥ 20%) for research or drug intermediate applications

Non-Negotiable Verification Points

1. Demand Aflatoxin Results on Every Batch - Not Just the First Sample Nigella sativa seeds carry documented aflatoxin risk. Any supplier who cannot provide HPLC-FLD or validated ELISA aflatoxin results on every production batch is a supply chain liability. Do not accept a supplier declaration in place of analytical data.

2. Verify TQ by HPLC with Certified Reference Standard (CAS 490-91-5) TQ content is the primary value marker. HPLC quantification must use a certified thymoquinone reference standard. UV spectrophotometry alone cannot distinguish TQ from structurally similar compounds in the extract matrix.

3. Confirm Format - Powder vs. Oil - Before Ordering Powder (ethanol-extracted, TQ ≥ 5%/10%/20%) and oil (cold-pressed, TQ ≥ 5%/10%) have different bioactive profiles, solubility characteristics, and application targets. Powder is suited for capsules, tablets, and food additives. Oil is suited for softgels, topical cosmetics, and liquid formulations.

4. Verify Halal Certification Source For halal-market products, the certifying body matters. Halal certificates from recognized international bodies (JAKIM, IFANCA, HFA, MUI) carry market credibility that generic declarations do not.

5. Check Pesticide Compliance for Your Target Market A multi-residue pesticide screen compliant with EU Regulation 396/2005 or USP <561> is the minimum standard for regulated market entry.

6. Confirm Packaging Integrity TQ is volatile and oxidation-sensitive. Confirm that finished extract is packed in opaque, foil-lined or nitrogen-flushed packaging - stored at ≤ 25°C, RH ≤ 40%.

Q1: What is the difference between Nigella sativa extract powder and black seed oil?

Black seed oil is produced by cold pressing Nigella sativa seeds to yield the fixed oil fraction - rich in linoleic acid, oleic acid, and thymoquinone at relatively low concentrations (typically 0.4–1.5% TQ in unprocessed oil). Our oil grade is enriched through a proprietary cold-press and enrichment extraction process to achieve TQ ≥ 5% or ≥ 10%. Extract powder is produced by ethanol and water extraction to concentrate TQ to standardized levels (5%, 10%, 20%). Powder is preferred for capsules, tablets, and food additive applications. Oil is preferred for softgels, liquid formulations, and cosmetic topicals.

Q2: Why is aflatoxin testing specifically important for Nigella sativa?

Nigella sativa seeds are an oilseed crop grown in warm, humid regions where Aspergillus mold species - the aflatoxin-producing fungi - thrive under certain pre-harvest and post-harvest conditions. EU food safety authorities have flagged Nigella sativa seeds as a commodity with elevated aflatoxin risk in import surveillance programs. Aflatoxin B1 is classified as a Group 1 human carcinogen by the International Agency for Research on Cancer (IARC). The EU maximum limit is 4 µg/kg total aflatoxins. Our internal acceptance limit is 2 µg/kg - more stringent than the regulatory requirement - and aflatoxin results appear on every COA.

Q3: What clinical and pharmacological evidence supports thymoquinone's bioactivity?

Published peer-reviewed research documents TQ's activity across multiple physiological systems. Key findings include: inhibition of acute myeloid leukemia cell proliferation via apoptosis-related protein modulation (Chinese Journal of Experimental Hematology, 2025); attenuatioFAQn of LPS-induced cardiac fibrosis in rats (China Pharmacy, 2019); cardioprotection in hyperlipidemia models (Chinese Clinical Pharmacology and Therapeutics, 2022); inhibition of skin squamous cell carcinoma via the Caspase-3/Bax/Bcl-2 pathway (Chinese Journal of Medical Aesthetics and Cosmetology, 2021); and reduction of experimental periodontitis without organ toxicity (Shihezi University, 2024). We can provide a curated research summary upon request.

Q4: Is Nigella sativa extract suitable for use in EU food supplements?

Nigella sativa has a documented history of use as a food spice and traditional medicine across multiple EU member states and is not currently listed on the EU Novel Food Catalogue as requiring authorization. It is marketed as a food supplement ingredient across EU markets. However, specific health claims require EFSA authorization under EU Regulation (EC) No 1924/2006. EU-market products should use structure/function language compliant with national regulations in each member state. Consult your EU regulatory affairs team for country-specific claim guidance.

Q5: What is the recommended inclusion rate for an immune support supplement?

Published clinical studies on Nigella sativa have used doses ranging from 500 mg to 2,000 mg of seed powder per day. For a standardized extract at 3% TQ, delivering approximately 30 mg TQ/day requires around 1,000 mg of extract per day. At our 10% TQ grade, the same TQ dose requires only 300 mg of extract per day - allowing more compact capsule formats. Dosage should be validated against your specific label claims and target market regulations.

Q6: Who should not use Nigella sativa extract?

Contraindicated populations include pregnant women, breastfeeding women, infants and young children, individuals with known Nigella sativa allergy, those with hypotension, and those with coagulation disorders. Use should be discontinued at least 2 weeks before surgery. Concurrent use with antihypertensive, anticoagulant, or antidiabetic medications requires medical supervision. These contraindications should be reflected in finished product labeling.

Q7: How do you ensure consistent TQ content across batches given natural seed variability?

TQ content in raw Nigella sativa seeds varies by geographic origin, harvest season, and post-harvest handling. We manage this variability through three mechanisms: (1) incoming seed lot HPLC pre-screening to establish TQ baseline before extraction; (2) extraction parameter adjustment based on incoming TQ content to optimize yield; and (3) post-extraction blending of batches to target specification when individual batch yields fall outside the acceptable range. Every released batch carries HPLC data confirming the stated TQ percentage against a certified reference standard (CAS 490-91-5).

Q8: Do you offer private label or white label services?

Yes. We offer private label packaging for orders above a defined minimum quantity. This includes custom label design support, packaging format selection (capsules, softgels, sachets, bulk powder, oil), Halal and Kosher certificate transfer documentation, and regulatory documentation tailored to your target market (US, EU, GCC, Southeast Asia, Australia). The halal-certified private label service is particularly relevant for buyers targeting Middle Eastern and Southeast Asian markets. Contact info@jiuybiotech.com for a private label inquiry form.

At Jiuyuan Bio, we supply Nigella Sativa Extract to supplement brands, cosmetic formulators, pharmaceutical manufacturers, and halal-certified product developers across North America, Europe, the GCC, and Asia-Pacific. Every batch we ship is authenticated, aflatoxin-screened, thymoquinone-standardized, and fully documented.

What every order includes:

• HPLC-verified thymoquinone content (CAS 490-91-5, certified reference standard)
• Aflatoxin screening results (HPLC-FLD) - on every COA, without exception
• Halal and Kosher certificates from recognized certifying bodies
• Full COA with third-party test reports available
• ISO 22000-certified manufacturing with HACCP controls
• Both powder (TQ ≥ 5%, 10%, 20%) and oil (TQ ≥ 5%, 10%) formats available
• Responsive technical support from sample request through commercial scale-up

Connect with our team:

📧 info@jiuybiotech.com

🌐 www.jiuyuanbio.com

Sample requests, technical data sheets, aflatoxin reports, Halal certificates, and full document packages are available on request. All B2B inquiries receive a response within one business day.