Bulk L Ergothioneine Powder

Shaanxi Rebecca Biotechnology Co., Ltd. has the most advanced fermentation facilities and chromatographic purification system. Our annual manufacturing capacity is on the metric-ton range and is backed by multi-stage quality checkpoints.

Our R&D team focuses on chiral separation technology to guarantee that D-isomer contamination is below detection limits. We have full testing equipment, such as HPLC with chiral columns, ICP-MS for heavy metal analysis, and microbial testing facilities certified to international standards.

All items conform with ISO9001, HACCP, FSSC22000, Halal certifications. Customisation options for particle size, package configurations and documentation needs to meet your regulatory market.

Our product is based on fermentation powered by synthetic biology, using food grade substrates. This approach avoids genotoxic contaminants associated with chemical synthesis routes while retaining entire L-configuration.

The starting components are pharmaceutical grade L-histidine, glucose and yeast extract. We preserve the genealogy of our modified strains by cryopreserving master cell banks.

Grades range from 98% dietary supplement grade to 99.9% pharmaceutical-grade, with impurity profiles for each grade recorded in the batch-specific Certificates of Analysis.

Solubility Characteristics:

· Water: Extremely soluble (90+ g/L at 25°C)

· Methanol/Ethanol: Readily soluble

· Propylene Glycol: Soluble

· Vegetable Oils: Requires emulsification systems

Stability Parameters:

· Thermal stability up to 100°C suitable for pasteurization processes

· Optimal pH stability window: 3.0-8.0

· Photosensitive; requires amber packaging for liquid formulations

· Hygroscopic nature controlled through specialized crystallization morphology

The process starts with activation of the modified bacterial strain through controlled multiplication of seed culture. For optimal yield, fermentation is performed in 5000 L bioreactors with strict control of temperature and pH and progressive feeding of the nutrients.

The processing after fermentation involves high pressure cell disruption and ceramic membrane microfiltration to remove the cellular debris. Nanofiltration steps remove small molecule contaminants but retain the target compound.

The crucial control point is the chiral chromatographic separation using a series of tandem ion-exchange and reversed-phase columns to provide enantiomeric purity greater than 99.9%. This procedure avoids racemic contamination that renders the product physiologically inactive.

Gradient recrystallisation in water-ethanol systems at controlled cooling rates has been investigated. High purity grades are subjected to three cycles of recrystallisation. Residual mother liquor is removed by counter-current washing and then hoover dried at temperatures below 50°C.

The final processing consists of cyclodextrin inclusion for improved dispersibility (if required), precise milling to the desired particle distribution, and three-dimensional homogenisation blending of different batches to reduce the variance of the content.

Cosmeceutical Formulations:

L-ergothioneine shields skin cells from oxidative damage caused by UV radiation. It makes a good ingredient in anti-aging serums, brightening creams and post-procedure healing products. The substance remains active in emulsion systems and penetrates the barrier of the stratum corneum.

Nutraceuticals Product:

Mitochondrial function and cell lifespan are supported by oral supplementation Bulk L Ergothioneine Powder mixes easily into tablets, capsules and functional beverage powders. Common synergistic combinations are collagen peptides, coenzyme Q10 or astaxanthin.

Functional advantage:

· Neutralizes hydroxyl radicals and peroxynitrite species

· Maintains DNA integrity under oxidative stress

· Supports cellular detoxification pathways

· Protects against environmental pollutant damage

Each batch is quality checked using a 16 point check including a specific HPLC method for chiral purity. Heavy metals testing is conducted to USP<233> with detection limits for lead, arsenic, cadmium and mercury less than 0.5 ppm cumulative.

Microbial testing is done for total plate count, yeast/mold, E. coli and Salmonella as per international pharmacopoeia guidelines. Analysis of residual solvent according to ICH Q3C criteria.

Third party verification can be performed by SGS, Eurofins or customer authorised labs. You can trace all the way back from the raw material lot number to the completed product batch code.

Standard packaging is nitrogen flushed aluminium foil inner bags, packed in moisture-proof fibre drums (net 25kg). Other options include 1kg, 5kg and 10kg units

Custom labelling, multi-language documentation and special packaging materials are available upon request. Temperature-controlled logistics ensures products are kept safe during international transit.

Standard lead time: 15-20 working days after deposit. Manufacturing offered to eligible accounts. All shipments are supplied with COA, MSDS, allergy declarations and country relevant regulatory documents.

Q: How do you check for enantiomeric purity so that you don’t contaminate with inactive D-isomer?

A: For each batch, chiral HPLC verification is performed and the ee values are individually reported on the COA. The L-configuration is guaranteed to be more than 99.9% by our multi-stage chromatographic process.

Q: How do you keep liquid formulations from discolouring during shelf life?

A: We present accelerated stability data under light/temperature stress. Recommendations include pH optimisation between 4.5-6.5, inclusion of chelators and amber packing techniques.

Q: How is commercial scale uniformity from batch to batch achieved?

A: Standardised strain banking, in-process analytical checkpoints, and completed product blending processes maintain assays, ee value, and colour to lower the tolerance bands throughout production runs.

Q: Can the powder also tolerate high temperature processing?

A: Thermal stability studies demonstrate no deterioration below 100°C. This allows it to be used in hot-fill operations, spray drying and pasteurisation cycles with no loss of activity.

Q: What paperwork supports clearance in important markets?

A: Complete dossiers including production flow diagrams, impurity profiles, stability studies, toxicity summaries and compliance statements for EU Novel Food, FDA GRAS and other jurisdictions.

For technical specifications, custom formulation support, or sample requests, contact our team at information@sxrebecca.com. We provide comprehensive application guidance to optimize Bulk L Ergothioneine Powder performance in your specific matrix.