EGCG 98% Technical Data Sheet | Blue Eyes Biotech
EGCG 98% Technical Data Sheet
This technical data sheet covers the full specification, physicochemical properties, analytical methods, stability profile, regulatory status, and formulation guidance for EGCG 98% — high-purity epigallocatechin-3-gallate powder produced from Camellia sinensis by chromatographic purification. It is intended as a B2B procurement and formulation reference for supplement brand owners, R&D teams, OEM manufacturers, and pharmaceutical ingredient buyers.
EGCG 98% is an ultra-high-purity isolate of epigallocatechin-3-gallate (CAS 989-51-5) produced from green tea (Camellia sinensis) leaves by chromatographic purification, yielding a white to off-white crystalline powder with ≥98.0% EGCG content by HPLC. It is practically decaffeinated (<0.1% caffeine) and is the highest commercially available purity grade of EGCG. It is used in pharmaceutical intermediates, clinical-grade nutraceuticals, premium topical cosmetics, and research applications requiring precise, analytically verified EGCG dosing.
1. Chemical Identity & Structural Data
| Property | Value |
|---|---|
| Preferred IUPAC Name | [(2R,3R)-5,7-dihydroxy-2-(3,4,5-trihydroxyphenyl)-3,4-dihydro-2H-chromen-3-yl] 3,4,5-trihydroxybenzoate |
| Common Name | Epigallocatechin-3-gallate; EGCG; Epigallocatechin gallate |
| Synonyms | (−)-Epigallocatechin gallate; (−)-cis-2-(3,4,5-Trihydroxyphenyl)-3,4-dihydro-1(2H)-benzopyran-3,5,7-triol 3-gallate |
| CAS Number | 989-51-5 |
| MDL Number | MFCD00075940 |
| FDA UNII | BQM438CTEL |
| PubChem CID | 65064 |
| Molecular Formula | C₂₂H₁₈O₁₁ |
| Molecular Weight | 458.37 g/mol |
| InChI Key | WMBWREPUVVBILR-WIYYLYMNSA-N |
| SMILES | Oc1cc(O)c2C[C@@H](OC(=O)c3cc(O)c(O)c(O)c3)[C@H](Oc2c1)c4cc(O)c(O)c(O)c4 |
| Compound Class | Flavan-3-ol (Catechin); Polyphenol; Flavonoid |
| Optical Rotation [α]D | −185 ± 2° (c = 1, EtOH) |
| Stereochemistry | (2R,3R) configuration; (−) enantiomer |
Table 1 — Chemical Identity Data for EGCG 98%
2. Full Product Specification — EGCG 98%
All specifications below are batch-specific and verified by the stated analytical method. A batch-specific Certificate of Analysis (COA) is issued for every production lot and available upon request.
| Parameter | Specification | Test Method |
|---|---|---|
| EGCG Content (Assay) | ≥ 98.0% (w/w) | HPLC — USP <621>; calibrated to USP reference standard USP-1236700 |
| Total Catechins | ≥ 98.0% (sum: EGCG + ECG + EGC + EC + GCG) | HPLC with Rs ≥ 2.0 resolution between EGCG and GCG peaks |
| ECG (Epicatechin-3-gallate) | ≤ 1.0% | HPLC |
| EGC (Epigallocatechin) | ≤ 0.5% | HPLC |
| EC (Epicatechin) | ≤ 0.3% | HPLC |
| GCG (Gallocatechin gallate — epimer) | ≤ 1.0% | HPLC — separately resolved from EGCG peak; Rs ≥ 2.0 confirmed |
| Caffeine Content | < 0.1% (practically decaffeinated) | HPLC |
| Appearance | White to off-white crystalline powder | Visual inspection |
| Odor | Characteristic, slight green tea; no off-odor | Organoleptic |
| Moisture Content | ≤ 4.0% | Karl Fischer (USP <921>) |
| Water Activity (Aw) | ≤ 0.50 | Water activity meter |
| Particle Size (D90) | ≤ 150 μm (100–200 mesh) | Laser diffraction |
| Bulk Density | 0.25–0.45 g/cm³ | USP <616> |
| Tapped Density | 0.35–0.55 g/cm³ | USP <616> |
| pH (1% aqueous solution) | 3.5–5.5 | USP <791> |
| Melting Point | 222–224°C | USP <741> |
| Lead (Pb) | ≤ 0.1 ppm | ICP-MS — USP <232> |
| Arsenic (As) — Total | ≤ 0.3 ppm | ICP-MS |
| Arsenic — Inorganic (As³⁺ + As⁵⁺) | ≤ 0.02 ppm | HPLC-ICP-MS per EN 16802:2016 |
| Cadmium (Cd) | ≤ 0.1 ppm | ICP-MS |
| Mercury (Hg) | ≤ 0.05 ppm | ICP-MS / CVAAS |
| Pesticide Residues | Compliant with EU Regulation EC 396/2005 MRLs | GC-MS/MS + LC-MS/MS multi-residue panel (≥200 analytes) |
| Residual Solvents | Ethanol ≤ 5,000 ppm; no Class 1/2 solvents detected | GC-Headspace — USP <467> / ICH Q3C |
| Total Aerobic Count (TAC) | ≤ 100 CFU/g | USP <2021> / ISO 4833 |
| Yeast & Mold | ≤ 10 CFU/g | USP <2021> |
| E. coli | Absent in 10g | USP <2022> |
| Salmonella spp. | Absent in 25g | USP <2022> / ISO 6579 |
| Staphylococcus aureus | Absent in 10g | USP <2022> |
| Botanical Identity | Confirmed Camellia sinensis | HPLC fingerprinting + DNA barcoding |
| Shelf Life (sealed) | 24 months from date of manufacture | ICH Q1A(R2) accelerated stability validated |
Table 2 — Full Product Specification, EGCG 98%. All parameters are batch-specific. Contact Blue Eyes Biotech for current batch COA.
At 98% purity grade, the HPLC method must achieve chromatographic resolution Rs ≥ 2.0 between the EGCG peak and the GCG (gallocatechin gallate) epimer peak. Fast-gradient HPLC methods that co-elute EGCG and GCG will overstate EGCG purity by 2–8%. Buyers should confirm Rs value is documented in the COA method statement. USP reference standard USP-1236700 must be used for EGCG calibration.
3. Physicochemical Properties
| Property | Value | Conditions / Notes |
|---|---|---|
| Physical State | Solid — crystalline powder | At 25°C, ambient conditions |
| Color | White to off-white | 98% purity grade; lower purity grades appear light tan to brown due to residual polyphenols and chlorophyll |
| Melting Point | 222–224°C | Decomposition may occur above 220°C; do not process at high temperature |
| Density (predicted) | 1.90 ± 0.1 g/cm³ | Crystalline solid |
| pKa (predicted) | 7.75 ± 0.25 | Relevant to pH-dependent stability and ionization in solution |
| LogP (partition coefficient) | 0.639 (estimated) | Low LogP; moderate hydrophilicity; water-soluble at pharmaceutical concentrations |
| Optical Rotation [α]D²⁰ | −185 ± 2° | c = 1, ethanol; confirms (−) enantiomer / (2R,3R) stereochemistry |
| Solubility — Water | ≥ 4.58 mg/mL (10 mM) at 25°C — clear solution | Solubility decreases at higher pH; increases with sucrose co-formulation (up to 26.7 mg/mL in optimized matrix); "slightly soluble" per Ph. Eur. at pure form |
| Solubility — Ethanol | Freely soluble up to 45.84 mg/mL (100 mM) | Clear solution |
| Solubility — DMSO | Freely soluble ≥ 45 mg/mL | For laboratory / research use |
| Water Solubility (practical) | Soluble — clear, faint yellow solution at ≤ 5 mg/mL | Solution stability is pH and time dependent — see Section 5 |
| Light Sensitivity | Yes — photosensitive | Protect from UV and direct light; use amber or foil-opaque containers |
| Hygroscopicity | Slightly hygroscopic | Maintain sealed container; desiccant inclusion recommended |
| Incompatibilities | Strong oxidizing agents; alkaline conditions (pH >7); transition metals (Fe, Cu) | Fe and Cu catalyze Fenton-type oxidative degradation; avoid metal equipment contact during processing |
Table 3 — Physicochemical Properties of EGCG 98%
4. Analytical Methods & Testing Standards
The primary assay method for EGCG 98% is reverse-phase HPLC per USP <621>, calibrated to USP reference standard USP-1236700, with chromatographic resolution Rs ≥ 2.0 between EGCG and GCG peaks. Linearity has been validated over 50–150 μg/mL with R² ≥ 0.9991. Method validation per ICH Q2(R1) covers specificity, linearity, accuracy (recovery 99.1–100.4%), precision (RSD <2%), and robustness. UV detection at 280 nm is used for catechin quantification.
| Test | Method / Standard | Key Parameters |
|---|---|---|
| EGCG Assay (Primary) | RP-HPLC — USP <621>; USP-1236700 reference standard | Column: C18; Mobile phase: acetonitrile/water/acetic acid gradient; UV at 280 nm; Rs ≥ 2.0 (EGCG vs GCG); Linearity R² ≥ 0.9991; LOQ ≤ 0.05%; ICH Q2(R1) validated |
| Catechin Profile (EGCG, ECG, EGC, EC, GCG) | RP-HPLC — extended gradient | All five catechins individually resolved and quantified; GCG reported separately to confirm EGCG peak purity |
| Caffeine Determination | HPLC — UV at 272 nm | LOQ ≤ 0.05%; confirms decaffeinated status (<0.1%) |
| Botanical Identity | HPLC fingerprinting + DNA barcoding (Camellia sinensis-specific PCR) | Catechin fingerprint matches C. sinensis reference; DNA confirms species and excludes adulteration |
| Moisture / Water Content | Karl Fischer titration — USP <921> | Limit: ≤ 4.0%; Karl Fischer preferred over LOD for accuracy at low moisture levels |
| pH (1% solution) | USP <791> | Spec: 3.5–5.5; prepare fresh; measure within 15 min of dissolution |
| Heavy Metals — Full Panel | ICP-MS — USP <232>/<233>; EPA Method 200.8 | Pb, As total, As inorganic (HPLC-ICP-MS per EN 16802:2016), Cd, Hg; LOQ ≤ 0.02 ppm for inorganic As |
| Pesticide Residues | GC-MS/MS + LC-MS/MS multi-residue panel | ≥200 analytes per EU MRL Regulation EC 396/2005; ISO 17025 accredited lab |
| Residual Solvents | GC-Headspace — USP <467> / ICH Q3C | Class 1 solvents: not detected; Class 2: ethanol ≤5,000 ppm; no acetone, hexane, or chlorinated solvents |
| Microbial — Total Aerobic | USP <2021> / ISO 4833 | Limit: ≤100 CFU/g (stricter than standard supplement grade of 1,000 CFU/g) |
| Microbial — Pathogens | USP <2022> / ISO 6579 | E. coli absent/10g; Salmonella absent/25g; Staph. aureus absent/10g |
| Optical Rotation | Polarimetry — USP <781> | [α]D²⁰ = −185 ± 2° (c=1, EtOH); confirms (−) enantiomer purity |
| Melting Point | USP <741> | 222–224°C; deviations indicate impurity or polymorphic change |
| Particle Size | Laser diffraction | D90 ≤ 150 μm; D50 reported; suitable for capsule filling and blending operations |
Table 4 — Analytical Methods for EGCG 98%. All methods are batch-applied; results reported on batch-specific COA.
5. Stability Profile & Degradation Chemistry
EGCG 98% undergoes two primary degradation pathways: (1) epimerization — thermally induced conversion to GCG (gallocatechin gallate), reducing EGCG content with no visible color change; and (2) oxidation — auto-oxidation and metal-catalyzed oxidation to quinone derivatives, producing browning and loss of antioxidant activity. In aqueous solution at neutral pH (7.0), a 0.3 mg/mL EGCG solution at room temperature loses >18% purity in 2.5 hours. At 4°C in the same system, purity loss is <0.2% over 2 hours. Dry crystalline powder maintains specification for 24 months when stored at ≤25°C, <60% RH, sealed, dark, and in an inert atmosphere.
5.1 — Stability by Storage Condition (Dry Powder)
| Storage Condition | Expected EGCG Retention | Shelf Life | Risk Level |
|---|---|---|---|
| 2–8°C / nitrogen atmosphere / sealed / dark | >98% retention | 24+ months | Optimal |
| ≤25°C / <60% RH / nitrogen flush / sealed / dark | ≥98% retention | 24 months | Recommended |
| 25°C / 60% RH / sealed / no nitrogen | ~95% retention at 12 months | 18–24 months | Acceptable with monitoring |
| 40°C / 75% RH (ICH accelerated condition) | ~48% loss over 6 months | <3 months | Do Not Store Under These Conditions |
| Opened container / ambient / unprotected | Rapid degradation | 30–60 days | High Risk — Re-purge with N₂ after each use |
Table 5 — EGCG 98% Dry Powder Stability by Storage Condition. ICH Q1A(R2) accelerated stability data available on request.
5.2 — Stability in Aqueous Solution
| Solution Condition | EGCG Stability | Practical Notes |
|---|---|---|
| pH 1.6 / room temperature | Stable for ≥ 96 hours | Highest aqueous stability; mimics gastric conditions |
| pH 3.5–4.5 / 4°C / sealed / dark | Stable 48+ hours; >95% retention | Target pH range for RTD beverages; ascorbic acid co-formulation extends stability significantly |
| pH 5 / room temperature | Stable for ~48 hours | Acceptable for short shelf-life liquid applications |
| pH 7 / room temperature (0.3 mg/mL) | Purity loss to ~81.7% in 2.5 hours | Neutral pH solutions are not suitable without antioxidant stabilization |
| pH 7 / 4°C (0.3 mg/mL) | Minimal loss (<0.2%) over 2 hours | Refrigeration dramatically slows degradation at neutral pH; not a long-term solution |
| pH 9 / room temperature | Fully degraded within 4 hours | Alkaline formulations are incompatible with EGCG |
| Any pH / 120°C / 105 minutes | ~70% loss in 105 minutes | Hot-fill processing incompatible; cold-fill or aseptic processes only |
Table 6 — EGCG 98% Solution Stability by pH and Temperature. Fresh preparation recommended for all liquid applications.
5.3 — Key Degradation Factors and Mitigation
| Degradation Factor | Mechanism | Mitigation Strategy |
|---|---|---|
| Heat (>25°C) | Epimerization (EGCG → GCG); oxidative degradation rate increases exponentially with temperature | Store at ≤25°C dry; ≤4°C in solution; never hot-fill; avoid prolonged room-temperature exposure |
| High Humidity (>60% RH) | Promotes hydrolytic degradation; lowers glass transition temperature (Tg) of powder matrix | Maintain Aw ≤ 0.50; store with desiccant; hermetically seal after each use |
| Alkaline pH (>5) | EGCG phenolic groups deprotonate above pKa (~7.75), forming radical species; accelerated oxidation | Formulate at pH 3.5–4.5; buffer with citric acid; avoid alkaline co-excipients |
| Oxygen / Air Exposure | Auto-oxidation; quinone formation; irreversible loss of antioxidant capacity and EGCG content | Nitrogen or argon atmosphere during storage and processing; minimize headspace; inert packaging |
| UV / Visible Light | Photo-oxidation; radical-mediated degradation; browning | Amber glass or foil-opaque packaging; shield from all light sources during processing |
| Transition Metals (Fe, Cu, Mn) | Fenton reaction catalysis; dramatically accelerates oxidative degradation in solution | Use chelating agents (EDTA, citric acid) in liquid formulations; use stainless steel or food-grade plastic equipment |
| High Concentration in Solution | Concentrated solutions promote epimerization over irreversible oxidation — partially reversible | Co-formulate with sucrose or carbohydrates to improve solubility; ascorbic acid at 1:1 ratio with EGCG (w/w) provides antioxidant protection |
Table 7 — EGCG 98% Degradation Factors and Mitigation Strategies
6. Storage Conditions & Handling Requirements
7. Formulation Guidance by Application
| Application | Recommended Loading | Key Formulation Considerations | Stability Risk |
|---|---|---|---|
| Hard Shell Capsule (HPMC or Gelatin) | 50–400 mg EGCG/capsule | Blend with MCC or dicalcium phosphate as diluent; add 0.5% colloidal silicon dioxide for flow; use nitrogen-purged blending vessel; avoid moisture-generating excipients | Low — if capsule shell excludes moisture |
| Compressed Tablet | 50–400 mg EGCG/tablet | Direct compression preferred; avoid wet granulation; add 0.5–1.0% ascorbic acid as antioxidant excipient; film coat with moisture-barrier coat (HPMC-based); low-compression force to avoid heat generation | Medium — moisture and heat from compression |
| RTD Beverage / Oral Liquid | 100–500 mg EGCG per serving | pH must be 3.5–4.5 (buffer with citric acid); include ascorbic acid at 1:1 ratio with EGCG (w/w); sucrose or glucose improves solubility and stability; nitrogen headspace purge before sealing; amber or opaque packaging; cold-fill process only; shelf-life stability study mandatory before launch | High — strict formulation controls required |
| Topical Serum / Cosmetic | 0.1–2.0% EGCG (w/w) in final formulation | Formulate at pH 4.0–5.5; include antioxidant system (Vitamin E, ascorbic acid); use chelating agent (EDTA 0.05%); opaque or airless pump packaging; 98% grade provides color advantage — no green discoloration in formulation | Medium — pH and packaging control critical |
| Powder Blend / Sachet | 100–500 mg EGCG per sachet | Blend with vitamin C as antioxidant carrier; use moisture-scavenging excipients; nitrogen-flush sachet before sealing; foil-laminate sachets mandatory; advise consumer to dissolve in cold water immediately before use | Medium — sachet barrier quality critical |
| Pharmaceutical Intermediate / API | As per formulation requirement | ICH Q2(R1) validated analytical method required; USP-traceable COA with optical rotation confirmation; full ICH Q3C residual solvent panel; ICH Q1A stability data at proposed storage conditions; DMF filing support available | Contact technical team for pharma-grade protocol |
Table 8 — EGCG 98% Formulation Guidance by Application Type
Adding ascorbic acid (Vitamin C) at a 1:1 ratio (w/w) with EGCG in liquid and topical formulations significantly reduces oxidative degradation — up to 88% loss prevention documented in neutral pH environments. However, in dry solid dosage forms, ascorbic acid may accelerate moisture-induced degradation. Evaluate stability data for the specific matrix before including in dry blends.
8. Regulatory Status & Market Compliance
| Market | Regulatory Framework | EGCG 98% Status | Key Compliance Requirements |
|---|---|---|---|
| European Union | EU Regulation 2022/2340; EFSA Opinion (2018); Novel Food Regulation 2015/2283 | Permitted as food supplement ingredient; ≥90% EGCG purity preparations may be subject to Novel Food authorization — confirm with EU regulatory counsel | <800 mg EGCG/day per serving; mandatory hepatotoxicity label warnings; inorganic arsenic speciation per EU 2023/915; EU MRL pesticide compliance |
| United States | FDA — DSHEA; 21 CFR Part 111 (cGMP); USP Dietary Supplement Compendium | Dietary supplement ingredient; NDI notification risk for ≥95% isolates — consult regulatory counsel before launch | cGMP facility certification; botanical identity testing per 21 CFR 111.75; USP-traceable COA; Prop 65 Pb compliance if selling in California (LOQ ≤0.05 ppm Pb required) |
| Canada | Health Canada — Natural Health Products Regulations; List of Permitted Supplemental Ingredients | Permitted as NHP ingredient and supplemental ingredient in food (with conditions) | RMDI ≤300 mg EGCG/day supplemental; max 100 mg/serving; mandatory cumulative consumption warning label |
| United Kingdom | FSA; UK NHP regulatory framework post-Brexit | Permitted; EFSA-equivalent safety guidance applied | <800 mg EGCG/day; hepatotoxicity warnings recommended |
| Australia | TGA — Therapeutic Goods Act; Complementary Medicines | Requires TGA Listed Medicine registration for therapeutic claims | ARTG listing; label claims restricted to TGA-approved wording |
| Japan | MHLW; FOSHU; FFC (Food with Function Claims) | Permitted as food ingredient; FOSHU approval required for health claims | No explicit EGCG cap for food applications; FOSHU dossier required for health claim use |
Table 9 — EGCG 98% Regulatory Status by Market. Confirm current status with qualified regulatory counsel in each market before product launch.
9. Packaging, Supply & Commercial Information
| Parameter | Details |
|---|---|
| Standard Packaging | 1 kg: double-layer aluminum foil bag, nitrogen-flushed, heat-sealed, inside HDPE drum. 5 kg: aluminum foil inner bag, nitrogen-flushed, inside fiber drum with PE liner. Custom packaging available on request. |
| Sample Availability | 50g and 200g technical samples available for qualification; batch-specific COA provided with every sample |
| Minimum Order Quantity (MOQ) | 1 kg commercial order; samples available below 1 kg for qualification purposes |
| Standard Lead Time | 7–14 business days for stock grades; 3–5 weeks for custom batch production |
| Price Range (2025–2026 reference) | USD $120–375/kg depending on volume, certification requirements, and customization |
| Available Certifications | GMP, ISO 9001, HACCP, Halal, Kosher; USDA/EU Organic upon request (minimum order volume applies) |
| Origin | Camellia sinensis leaves — sourced from certified gardens; processing and chromatographic purification at GMP-certified facility |
| Documentation Provided | Batch-specific COA (full parameter set); GMP facility certificate; HPLC chromatogram; Kosher/Halal certificates; Safety Data Sheet (SDS); product specification sheet; stability data summary |
| OEM / Custom Services | Custom standardization, particle size specification, co-formulation feasibility assessment, private label, and contract manufacturing available |
Table 10 — EGCG 98% Packaging, Supply & Commercial Information
Request EGCG 98% — Sample, COA & Technical Consultation
Blue Eyes Biotech supplies GMP-certified EGCG 98% with full batch-specific COA, HPLC chromatogram, and stability data. Technical formulation support included. OEM and private label available.
10. Technical FAQ
At 98% purity, the chromatographic purification process removes chlorophyll, caffeine, tannins, and the bulk of other polyphenolic impurities that give lower-grade extracts their characteristic brown or tan color. The result is a highly refined white to off-white crystalline powder. This color purity makes EGCG 98% suitable for color-sensitive formulations such as clear serums, capsules, and transparent beverages where green discoloration from lower-grade extracts would be problematic.
GCG (gallocatechin gallate) is the epimerized form of EGCG — produced when EGCG is exposed to elevated temperature during extraction or storage. The two molecules are structural isomers with essentially identical molecular weight and UV absorption, but differ in stereochemistry at the C-3 position. GCG has significantly lower bioactivity than EGCG. HPLC methods with insufficient resolution (Rs <2.0) will co-elute EGCG and GCG as a single peak, inflating stated EGCG purity by 2–8%. A COA for 98% EGCG must confirm that GCG is separately resolved and reported — typically ≤1.0% for a true 98% product.
The most effective stabilization system combines four elements: (1) acidic pH 3.5–4.5 buffered with citric acid — the most critical factor; (2) ascorbic acid at 1:1 ratio (w/w) with EGCG as a sacrificial antioxidant, providing up to 88% loss prevention; (3) nitrogen headspace purge to eliminate dissolved oxygen; (4) opaque UV-blocking packaging. A sucrose matrix significantly improves EGCG solubility from ~4.6 mg/mL to 26.7 mg/mL in an optimized formulation. Cold-fill or aseptic processing is mandatory — hot-fill is incompatible with EGCG stability.
This remains an unresolved regulatory question as of 2026. Crude green tea extract has pre-DSHEA (1994) market precedent, but chromatographically purified EGCG isolates at ≥95–98% are chemically distinct from traditional GTE. As of the date of this publication, no NDI notifications for ≥95% EGCG isolate appear in the FDA public NDI database. Buyers formulating EGCG 98% for the US dietary supplement market are strongly advised to consult qualified FDA regulatory counsel before launch.
Every commercial order from Blue Eyes Biotech is accompanied by: a batch-specific COA covering all parameters in the specification table; the HPLC chromatogram showing individual catechin peak separation including GCG; the GMP facility certificate; a Safety Data Sheet (SDS); Halal and Kosher certificates where applicable; and a product specification sheet. Stability data summary (ICH Q1A), optical rotation results, and third-party lab verification reports are available upon request.
No. EGCG 98% as supplied is a nutraceutical and pharmaceutical intermediate grade — it is not sterile and has not been validated for injectable use. Use as an injectable or intravenous API would require additional pharmaceutical processing under aseptic conditions, sterility testing per USP <71>, and pyrogen/endotoxin testing per USP <85>. This product is supplied for oral supplement, topical cosmetic, and non-parenteral pharmaceutical intermediate applications only.
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