| HS Code | 143916 |
| Product Name | VE powder/oil Pharma Grade API |
| Api Form | Powder and Oil |
| Dosage Forms | Tablet, Capsule, Granule, Injection, Oral, Injectable |
| Chemical Name | Vitamin E (alpha-tocopherol and/or tocopheryl derivatives) |
| Molecular Formula | C29H50O2 (alpha-tocopherol) |
| Molecular Weight | 430.71 g/mol |
| Description | High-purity pharmaceutical-grade vitamin E active pharmaceutical ingredient for oral and injectable formulations |
| Appearance | Powder form is white to off-white free-flowing powder; oil form is clear, viscous, pale yellow to amber liquid |
| Solubility | Powder is water-dispersible; oil is soluble in organic solvents, lipids, and surfactants, practically insoluble in water |
| Assay | 98.0% to 102.0% (on dried basis, HPLC) |
| Specific Rotation | +0.5° to +1.5° for natural form; synthetic form is racemic |
| Refractive Index | Approximately 1.495 to 1.500 at 20°C (oil form) |
| Residual Solvents | Meet ICH Q3C requirements |
| Particle Size | Powder form: D90 typically 100-200 µm; customizable for direct compression |
| Bulk Density | Powder form: 0.3-0.6 g/mL |
| Identification | Positive by HPLC, IR, and UV spectrophotometry |
| Storage Conditions | Store in tightly closed original container, protected from light, heat, moisture, and oxygen; recommended temperature 2-8°C for oil form, below 25°C for powder form |
As an accredited VE powder/oil Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaged in sealed, light-protected containers, available in 25 kg drums, ensuring stability and purity for oral and injectable pharmaceutical formulations. |
| Container Loading (20′ FCL) | 20′ FCL container loading: VE powder/oil Pharma Grade API packed in sealed drums/pallets, secured, ventilated, protected from moisture/heat. |
| Shipping | VE powder/oil Pharma Grade API is shipped in sealed, inert containers with desiccant, protected from light and moisture. Temperature-controlled transport ensures stability. Fully compliant with international pharmaceutical regulations, with clear labeling, documentation, and traceability for safe oral and injectable use. |
| Storage | Store VE powder/oil Pharma Grade API in tightly sealed, original containers in a cool, dry, well-ventilated area, protected from light, moisture, oxygen, and excessive heat. Recommended storage: 15–30°C. Avoid exposure to strong oxidizers. Keep away from incompatible materials. Maintain container integrity; use clean utensils to prevent contamination. Follow expiry labeling after opening. |
| Shelf Life | Shelf life: 24 months from manufacture date, when stored in original, unopened containers, protected from light, heat, and moisture. |
D-α-tocopheryl acid succinate granular powder with a declared potency of 1210 IU/g is blended with microcrystalline cellulose PH-102 (45–55% w/w) and dibasic calcium phosphate anhydrous (10–20% w/w). The active component addition ratio is 20–40% w/w of the tablet core; a 200 IU label claim corresponds to 165 mg of d-α-tocopheryl acid succinate in a 500 mg core, representing 33% w/w. Because the material shows bulk density in the range 0.35–0.55 g/mL and irregular particle morphology, direct compression at production scale leads to segregation during bin discharge and excessive weight variability. Dry granulation is therefore specified on a roller compactor with roll force 2.5–5.0 kN/cm, gap 2–3 mm, and oscillating mill screen 0.8–1.25 mm, producing granules with bulk density 0.55–0.70 g/mL and Carr index 18–24.
Tablet compression uses a 27-station rotary press with pre-compression 15–25 kN and main compression 60–80 kN. Target hardness is 80–120 N, and friability is controlled to ≤0.8% per USP <1216>. Content uniformity is assessed by USP <905>, and dissolution is run per USP <711> apparatus 2 at 75 rpm in 900 mL of 0.1 M HCl containing 0.5% sodium lauryl sulfate. Aqueous film coating with a PVA-based system at 2–3% w/w weight gain is applied when coated tablets are manufactured; pan air inlet temperature is held at 50–60°C and product temperature at 42–48°C. Terminal finished dosage types include uncoated, chewable, and film-coated tablets. Processing is limited to ambient relative humidity below 60%; above this threshold, the granulated material softens and picking becomes observable on the punch face.
Spray-dried d-α-tocopheryl acetate at 50% active loading is blended with lactose monohydrate (40–60% w/w), crospovidone (2–5% w/w), and magnesium stearate (0.5–1.0% w/w) for hard shell capsule powder fill; the active component addition ratio is 25–45% w/w of the filled powder mass. In high-shear mixing at 300–500 rpm impeller speed and 1500 rpm chopper speed for 3–5 min, the spray-dried matrix disperses uniformly, but hydration of crospovidone is avoided by limiting final water content of the blend to ≤2.0%. Lubrication is performed in a tumble blender at 12 rpm for 2 min; extended lubrication beyond 5 min has been observed on production batches to reduce dissolution rate due to hydrophobic magnesium stearate film formation.
Capsule filling is run on a rotary dosator-type machine with pin heights 17–21 mm for size 00 capsules, yielding fill weights 450–650 mg at 60,000–80,000 capsules/h. Disintegration acceptance is ≤30 min per USP <701> in water at 37°C, and dissolution is performed per USP <711> apparatus 2 with surfactant-containing medium. Release testing includes USP <905> for weight variation, USP <61>/62> for microbial quality, and Ph. Eur. 2.9.5 for single-dose mass uniformity. Terminal finished dosage types are hard gelatin and hypromellose two-piece capsules at 400 IU and 1000 IU label claim.
Rotary die encapsulation is selected when a single oral unit must deliver 400–1000 IU without the bulk constraints of dry powder fill. The fill formulation comprises d-α-tocopheryl acetate oily concentrate at 1360 IU/g as 85–95% w/w of the fill mass, diluted with medium-chain triglycerides or refined sunflower oil at 5–15% w/w. The oil is deaerated under vacuum at 50–100 mbar and supplied to the wedge through a heated line at 35–42°C. On a rotary die encapsulator, gelatin ribbon thickness is 0.8–1.0 mm, die roll speed is 8–14 rpm, and wedge temperature is 35–42°C; target seam thickness is 0.5–0.7 mm. Fill weight control is maintained within ±5% of target for fill masses from 300 mg to 1200 mg.
Drying is conducted in a tumble dryer at 20–25°C and 20–30% RH for 24–48 h until shell moisture reaches 6.0–8.0% by USP <921> Karl Fischer titration. Release testing includes gas chromatographic assay per Ph. Eur. 2.2.28 after saponification, USP <401> for oil identity and peroxide value, USP <701> disintegration, and USP <711> dissolution. Terminal finished dosage types are printed and unprinted soft gelatin capsules at 400 IU and 1000 IU. Process boundaries are narrow: at wedge temperatures above 45°C, ribbon tack increases and punctured capsule defects rise; at die roll speeds above 16 rpm, fill weight variability exceeds the ±5% control limit. Oxygen-sensitive fill oil should be handled under nitrogen and protected from copper or iron salts, which accelerate peroxide formation.
In fluid-bed top-spray granulation for single-dose oral granules, the hydrophobic surface of d-α-tocopheryl acid succinate requires aqueous pre-wetting with a povidone K30 solution at 2–4% w/w of dry granule mass. The active component addition ratio is 10–30% w/w; carbohydrate carriers such as sucrose or maltodextrin are used at 50–70% w/w, and colloidal silicon dioxide is included at 0.3–1.0% w/w to reduce static adhesion and improve flow. In a production-scale fluid-bed unit, inlet air temperature is set at 55–70°C, product temperature at 28–35°C, atomizing air pressure at 1.5–2.5 bar, and spray rate at 10–20 g/min per nozzle. Drying is continued until loss on drying is ≤2.0% per USP <731>.
Granules are filled into stick-pack sachets at 60–120 packs/min with fill mass 1–5 g; mass uniformity is verified per Ph. Eur. 2.9.5. Microbial limit testing follows USP <61> and USP <62>, with total aerobic microbial count 103 CFU/g and absence of Escherichia coli. Dissolution, where specified, is run after reconstitution using USP <711> apparatus 2 at 50 rpm. Terminal finished dosage types are single-dose sachets containing granules for direct oral administration or extemporaneous suspension in water. Granules are not suitable for high-fat enteral feeding tubes unless pre-sieved through 0.5 mm mesh due to agglomerate blocking risk.
For injectable dosage forms, d-α-tocopherol oil for parenteral use is incorporated into oil-in-water lipid emulsions at 0.2–2.0 mg/g of the lipid phase in parenteral nutrition admixtures, or formulated as an oily injection at up to 300 mg/mL in a terminally sterilized oily vehicle. The oil phase is heated to 70–75°C and the aqueous phase to 70°C before high-shear emulsification at 10,000–15,000 rpm, followed by microfluidization at 500–1000 bar to reduce mean droplet size to 200–400 nm measured by dynamic light scattering. Terminal sterilization is conducted at 121°C with F₀ ≥8–12 min. Emulsion flocculation is a known failure mode when pH falls below 6.8 or when divalent cations are present above 0.5 mEq/L; therefore the aqueous phase is buffered with sodium oleate or egg lecithin within narrow concentration ranges.
Sterility testing follows USP <71>, bacterial endotoxins are controlled per USP <85> with a limit of ≤0.5 EU/mg where specified, particulate matter is assessed per USP <788>, and injectable product requirements follow USP <1>. Container closure integrity is verified by dye ingress or vacuum decay after terminal sterilization. Terminal finished dosage types include glass ampoules, vials, and pre-filled syringes for intramuscular or intravenous administration under controlled clinical supervision. Oily injections cannot be directly mixed with aqueous infusions without a validated emulsifier system because immediate phase separation and droplet coalescence occur in the line.
Oral dose titration outside swallowable solid dosage forms uses d-α-tocopheryl acetate oily concentrate diluted into multi-dose oral drop formulations with medium-chain triglycerides or refined olive oil. The active component addition ratio is 20–50% w/w of the final oil solution, calibrated to deliver 30–50 IU per drop from a standard dropper. Nitrogen blanketing is applied throughout compounding and filling, and the solution is passed through a 0.45 µm polypropylene depth filter prior to filling into amber glass dropper bottles. Uniformity of mass for single-dose presentations is verified per Ph. Eur. 2.9.5, and microbial quality per USP <61>/62>. Terminal finished dosage types are multi-dose oral dropper bottles and single-dose oral unit-dose vials for pediatric and enteral administration. The oil solution should not be stored above 25°C or exposed to headspace oxygen exceeding 0.5% v/v because oxidative degradation accelerates and major degradation products increase beyond compendial limits.
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The VE powder/oil pharma-grade API is supplied either as a spray-dried alpha-tocopheryl acetate powder with a nominal 50.0% w/w active content or as a compendial-grade alpha-tocopheryl acetate oil with assay limits of 96.0–102.0% on an anhydrous, solvent-free basis. Representative model codes are manufacturer-specific: an oil grade designated for softgel and injectable emulsion manufacture may be coded VE-O-1400, indicating 1400 IU/g d-alpha-tocopherol equivalent, while a cold-water-dispersible powder grade may be coded VE-P-500, indicating 500 IU/g dl-alpha-tocopheryl acetate activity. The powder is produced by spray-drying dl-alpha-tocopheryl acetate onto a matrix of modified starch, silicon dioxide, and low-dextrose-equivalent maltodextrin, then sieved through a controlled mesh. It is used in tablet, capsule, granule, and sachet dosage forms; the oil is used for softgel fill, oily oral drops, and injectable emulsion compounding. Release testing for both forms includes identity by IR and high-performance liquid chromatography, assay, acid value, peroxide value, water content, residual solvents according to USP <467> and ICH Q3C, and elemental impurities according to ICH Q3D. Injectable oil is additionally tested for bacterial endotoxins according to USP <85> and microbial limits according to USP <61> and USP <62>. This release profile separates the pharma-grade material from food-grade or cosmetic-grade tocopheryl acetate, which may not be controlled for the same residual solvent, microbiological, or identity standards.
| Parameter | VE oil oral/injectable | VE powder 50% CWS |
|---|---|---|
| Active assay | 96.0–102.0% as alpha-tocopheryl acetate | 47.5–52.5% w/w |
| Physical form | Clear, pale yellow viscous oil | Off-white to cream spray-dried powder |
| Water content | ≤0.3% | ≤5.0% |
| Acid value | ≤1.0 mg KOH/g | ≤1.0 mg KOH/g |
| Peroxide value | ≤1.0 mEq/kg | ≤1.0 mEq/kg |
| Bacterial endotoxins | ≤0.5 EU/mg if injectable | Not applicable for oral use |
| Particle size | Not applicable | d90 ≤350 µm by USP <429> |
| Bulk density | Not applicable | 0.45–0.65 g/cm³ |
| Residual solvents | ICH Q3C | ICH Q3C |
| Elemental impurities | ICH Q3D | ICH Q3D |
For oral solid dosage unit operations, the powder grade is selected because it disperses rapidly in water at 25 °C and can be dry-mixed with microcrystalline cellulose, lactose monohydrate, dicalcium phosphate dihydrate, or mannitol in a bin blender. Direct compression on a rotary tablet press with compression force 8–25 kN is feasible at VE powder loading up to 30.0% w/w; above this level, ejection force increases and tablet capping may occur on high-speed presses. Tablet hardness of 6–10 kp is generally targeted for immediate-release tablets, with disintegration testing according to USP <701> and dissolution testing according to USP <711>.
For softgel and liquid-filled capsules, the oil form is selected. Fill weight is controlled with positive-displacement piston pumps on rotary die softgel encapsulators. The oil is stored under nitrogen overlay at 15–25 °C and protected from light; headspace oxygen is controlled to <2.0% where oxidative stability is critical. Because alpha-tocopheryl acetate is insoluble in water, aqueous liquid preparations use the powder grade dispersed with a surfactant such as polysorbate 80 at 0.5–1.0% w/w, followed by homogenisation.
Injectable formulations select the oil grade only when it meets the low-endotoxin and low-peroxide limits. Intramuscular or subcutaneous oily injection may be prepared by dilution with sesame oil or ethyl oleate, while intravenous administration requires emulsification with phospholipids and high-pressure homogenisation. Aqueous injection of undiluted oil is not performed because of embolic risk. The bacterial endotoxin limit is set at ≤0.5 EU/mg unless the daily dose calculation requires a lower limit; this is confirmed by USP <85>.
Spray-dried VE powder in tablet and capsule formulations behaves as a composite excipient rather than a simple active oil. The carrier matrix contributes 50.0% w/w of the dosage form mass, so tabletability and disintegration are controlled by the starch-maltodextrin-silicon dioxide system. Powder flow through a 15 mm orifice should be verified by USP <1174>; typical acceptance for this grade is 10–15 s/100 g when moisture content is below 5.0%. When ambient relative humidity exceeds 60%, the powder is pre-dried at 40–45 °C for 2 h in a tray dryer or fluid-bed dryer before blending; failure to do so can produce caking and erratic fill weight.
Capsule filling on an intermittent-motion dosator machine requires polished dosator pins and low compression settings; floodable powder may need tamping-pin force profiling on continuous-motion tamping machines. The powder is blended with colloidal silicon dioxide at 0.5–1.0% w/w to reduce segregation when mixed with free-flowing direct-compression excipients. Wet granulation is performed in a top-spray fluid bed at inlet air temperature 50–60 °C and product temperature 30–40 °C; granules are dried to final loss on drying ≤2.0% before compression. Published data for VE powder in effervescent or orally disintegrating tablet matrices is limited; formulation work should be confirmed with USP <711> dissolution and USP <701> disintegration rather than extrapolated from simple immediate-release tablets.
The oil is not water-soluble and is introduced into parenteral emulsions through a high-shear emulsification step. The oil phase is blended with egg phospholipids and medium-chain triglycerides, then passed through a high-pressure homogenizer at 70–100 MPa until mean droplet size is 200–500 nm measured by photon correlation spectroscopy. The emulsion is then sterilized by terminal moist-heat at 121 °C for 15 min; droplet size may increase slightly after autoclaving, so zeta potential and droplet size distribution are rechecked.
Incoming oil must have peroxide value ≤1.0 mEq/kg and acid value ≤1.0 mg KOH/g. Transition-metal contamination is controlled because dissolved ferric or cupric ions accelerate peroxide formation; formulation includes disodium edetate at a chelation stoichiometry determined by measured metal content. Filling is performed under nitrogen in amber borosilicate vials with headspace oxygen below 2.0%. Contact with unlined steel or copper alloy surfaces is avoided. Published data for VE oil in long-acting depot injection configurations is limited; each formulation should be evaluated for oxidative stability and sterility according to USP <71> and USP <85>.
Feed-grade mixed tocopherols may have lower assay, higher peroxide value, and no control of residual solvents or elemental impurities. Pharma-grade VE is different because it is released under a valid drug master file and manufactured under 21 CFR 210/211; each batch is tested for identity, assay, related compounds, residual solvents, elemental impurities, microbial quality, and endotoxin when needed. The synthetic dl-alpha-tocopheryl acetate is an all-rac mixture of eight stereoisomers, whereas d-alpha-tocopheryl acetate from natural sources is the RRR-configuration; compendial methods differentiate these by optical rotation and chiral chromatographic retention. The acetate ester is less oxidatively labile than free alpha-tocopherol, but requires enzymatic hydrolysis in vivo for antioxidant activity. This difference affects product selection: free tocopherol may be used where antioxidant activity is required during shelf life, while the acetate ester is preferred where chemical stability during granulation and tableting is the primary concern.
| Test | Method | Acceptance criterion |
|---|---|---|
| Assay | USP <621> | 96.0–102.0% oil; 47.5–52.5% powder |
| Acid value | USP <401> | ≤1.0 mg KOH/g |
| Peroxide value | USP <401> | ≤1.0 mEq/kg |
| Water content | USP <921> | oil ≤0.3%; powder ≤5.0% |
| Bacterial endotoxins | USP <85> | ≤0.5 EU/mg if injectable |
| Residual solvents | USP <467> | ICH Q3C limits |
| Elemental impurities | USP <232>/<233> | ICH Q3D PDE-based limits |
| Microbial enumeration | USP <61>/<62> | Total aerobic ≤1000 CFU/g; specified organisms absent |
| Sterility | USP <71> | Meets sterility for injectable grade |
For granule and sachet filling, the 50% CWS powder is dry-blended with directly compressible mannitol and a low-viscosity binder, then wet-granulated in a top-spray fluid bed at inlet air temperature 50–60 °C. Granules are dried to final moisture ≤2.0% and filled into stick packs at 1.0 g target fill weight using auger or dosing channel fillers. Exposure to ambient relative humidity above 60% during sachet filling should be limited to 2 h without re-drying; this boundary prevents caking on the dosing channel and maintains fill weight variability below ±3.0%.
For injection-grade oil, filling is performed under nitrogen in amber borosilicate vials, with headspace oxygen controlled below 2.0%. The oil is sterilized by filtration through a 0.22 μm hydrophobic membrane when solubility and viscosity allow; terminal moist-heat sterilisation at 121 °C for 15 min is used only for emulsion formulations that are thermodynamically stable after autoclaving.
