| HS Code | 637358 |
| Product Name | Lanolin Oil Pharma Grade API |
| Category | Pharmaceutical excipient / API |
| Dosage Forms | Tablet, Capsule, Granule, Injection |
| Route Of Administration | Oral and Injectable |
| Appearance | Clear to slightly viscous liquid, pale yellow to light amber |
| Odor | Mild characteristic odor, free from rancid odor |
| Solubility | Practically insoluble in water; soluble in chloroform, ether, acetone, and ethanol; miscible with fixed oils and fatty acid esters |
| Specific Gravity | 0.93 - 0.97 at 20°C |
| Refractive Index | 1.478 - 1.483 at 20°C |
| Saponification Value | 80 - 130 mg KOH/g |
| Iodine Value | 10 - 40 g I2/100g |
| Microbial Limits | TAMC ≤ 100 cfu/g, TYMC ≤ 100 cfu/g, complies with pharmacopoeial requirements |
As an accredited Lanolin 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 | Lanolin Oil Pharma Grade API is supplied in 25 kg HDPE drums with airtight liners, ensuring purity for oral, topical, and injectable formulations. |
| Container Loading (20′ FCL) | 20′ FCL container loaded with Lanolin Oil Pharma Grade API in sealed, palletized pharmaceutical-grade drums for oral and injectable use. |
| Shipping | Lanolin Oil Pharma Grade API is shipped in sealed, food-grade drums or containers to maintain purity and stability. Transport is via temperature-controlled, non-hazardous freight with moisture protection. Documentation includes certificate of analysis and safety data sheet. Deliveries worldwide ensure compliance with pharmaceutical supply chain regulations. |
| Storage | Store in a tightly closed, light-resistant container in a cool, dry, well-ventilated area. Maintain temperature between 15–25°C, protected from moisture, direct sunlight, and heat sources. Avoid contact with strong oxidizers. Keep away from incompatible materials. Ensure container remains sealed when not in use to preserve purity and stability for oral and injectable pharmaceutical formulations. |
| Shelf Life | Shelf life is typically 36 months when stored properly in tightly sealed, light-resistant containers under cool, dry conditions. |
In direct compression operations on a rotary tablet press running at 60–100 rpm, lanolin oil pharma grade is introduced at 0.5–2.0% w/w into the final powder blend through a heated spray nozzle maintained at 40±2°C. The addition sequence is fixed: the oil is sprayed onto the dry blend after the glidant but before the final disintegrant split, preventing premature adsorption onto microcrystalline cellulose and retaining disintegrant functionality in the outer tablet zone. Blending continues in a 50 L bin blender at 10–15 rpm for 15 min; mixing beyond 25 min is avoided because the hydrophobic film can migrate and reduce interparticulate bond strength, producing capping under compression. Ejection force is monitored on a 12-station rotary press with 8 mm flat-faced bevel-edge punches; the target ejection force is below 250 N. Tablet hardness is assessed under USP <1217>, and disintegration is measured in 900 mL purified water at 37±0.5°C by USP <701>. The lanolin oil used in this route must meet the pharmacopoeial monograph for lanolin oil, with peroxide value not exceeding 20 meq O₂/kg and acid value not exceeding 1.0 mg KOH/g; higher peroxide values accelerate oxidative degradation of oxygen-sensitive actives in the tablet core. This route is limited to immediate-release tablets because the hydrophobic binder can extend disintegration time beyond 30 min when the oil level exceeds 2.0% w/w and the formulation contains more than 20% w/w of poorly compressible filler.
Melt granulation with lanolin oil pharma grade is constrained by a narrow thermal window because the material melts between 38°C and 44°C and changes from a cohesive binder to a free-flowing liquid above 47°C. In a 10 L jacketed high-shear mixer, the dry blend is preheated to 45±2°C; lanolin oil is injected at 3.0–8.0% w/w while the impeller runs at 2.5–4.0 m/s tip speed and the chopper at 1500–3000 rpm. Granule growth is tracked by the increase in impeller power draw; endpoint is accepted when power consumption rises 15–20% over the dry load baseline, corresponding to agglomerates in the 0.8–1.6 mm range after sieving through a 1.6 mm mesh. Overheating above 52°C leads to uncontrolled coalescence and a bimodal particle-size distribution that cannot be corrected without re-milling. Tablets compressed from the lipid-melt granules are processed to 8–12 kp hardness using 10 mm round standard concave tooling. Dissolution testing under USP <711> Apparatus II at 50 rpm in 900 mL of pH 6.8 phosphate buffer shows a sustained-release pattern rather than immediate disintegration; the lipid matrix retards water penetration because lanolin oil is not wetted by aqueous media. This application is appropriate for oral sustained-release matrices where the active pharmaceutical ingredient is thermally stable up to 50°C for at least 30 min during granulation, and published data for highly water-soluble actives in this specific configuration remains limited.
For liquid-filled hard gelatin capsules, lanolin oil pharma grade functions as a lipophilic carrier and viscosity modifier at 20–50% w/w of the fill mass. The fill matrix is prepared in a jacketed stainless-steel vessel at 40±2°C and homogenized under a rotor-stator mixer at 3000 rpm for 15 min to disperse the active pharmaceutical ingredient. The oil is filtered through a 100 µm screen before transfer to a piston pump capsule filler. Filling is performed at fill weights controlled to ±5% using 0.4–1.2 mL dosing pistons; the fill temperature is maintained at 38–42°C to avoid the viscosity increase that reduces dosing accuracy below 40°C. Gelatin capsule shells are selected from a supplier qualified under USP <701> disintegration requirements; the low water activity of lanolin oil reduces shell crosslinking compared to more hygroscopic liquid vehicles. Accelerated stability testing at 40°C/75% RH for 6 months is used to detect fill leakage and shell deformation. Oxidative stability of the fill is controlled by selecting lanolin oil with peroxide value below 10 meq O₂/kg; if the peroxide value exceeds this threshold, lipid peroxidation products accelerate gelatin crosslinking and delay drug release. The release of the active pharmaceutical ingredient from the lipid matrix is evaluated in USP <711> Apparatus II with 0.1 N HCl for the first 2 h, followed by pH 6.8 buffer; emulsification of the lanolin oil contributes to the release profile.
| Route | Lanolin oil level | Processing temperature | Equipment type | Critical control limit | Pharmacopeial test |
|---|---|---|---|---|---|
| Direct compression tablet | 0.5–2.0% w/w | 40±2°C spray nozzle | 12-station rotary press, 8 mm punches | ejection force below 250 N | USP <1217>, USP <701> |
| Lipid-melt granulation | 3.0–8.0% w/w | 45±2°C jacket | 10 L high-shear mixer, 2.5–4.0 m/s tip speed | granule size 0.8–1.6 mm | USP <711>, USP <701> |
| Liquid-filled hard capsule | 20–50% w/w of fill | 38–42°C during filling | rotor-stator mixer, piston pump filler | fill weight variation ±5% | USP <711>, USP <701> |
| Extrusion-spheronization pellets | 2.0–6.0% w/w | 40–45°C drying | single-screw extruder, spheronizer plate | pellet friability below 0.5% w/w | sieve analysis, USP <701> |
Wet mass extrusion of high-dose actives benefits from lanolin oil as a plasticizing binder when the liquid addition is maintained below 6.0% w/w and the microcrystalline cellulose content remains above 50% w/w. The wet mass is blended in a planetary mixer for 5–8 min; lanolin oil is added after the water to reduce the aqueous surface tension and lubricate the die walls. Extrusion is performed in a single-screw extruder with 1.2 mm screen and screw speed 50–80 rpm; the barrel temperature is not intentionally heated because mechanical energy can raise the mass temperature above 40°C and cause the oil to separate. Spheronization runs on a 20 cm plate at 400–600 rpm for 2–4 min. Pellets are dried in a fluidized bed at 40–45°C until loss on drying is below 2.0%. The resulting pellets have a mean Feret diameter between 0.8 mm and 1.2 mm and are filled into hard gelatin capsules or compressed after mixing with extragranular disintegrant. Pellet friability is measured after 100 rotations in a friabilator; acceptable batches lose less than 0.5% w/w. This route is suited for actives that are sensitive to melt granulation temperatures because the process remains below 45°C while still providing uniform binder distribution.
Injectable use of lanolin oil pharma grade is restricted to intramuscular and subcutaneous depot formulations; intravenous administration is excluded because the oil phase can cause pulmonary oil embolism and particle-related microvascular occlusion. The vehicle is prepared by blending lanolin oil at 5–15% w/w with sesame oil or ethyl oleate in a jacketed vessel under nitrogen blanketing to limit oxidation. The blend is heated to 45–50°C and passed through a sterilizing-grade 0.22 µm PVDF filter at a differential pressure not exceeding 2.0 bar; higher pressures can bypass filter pores and compromise sterility assurance. Sterility is confirmed by USP <71> direct inoculation of the oil phase into fluid thioglycollate medium and soybean-casein digest medium. Bacterial endotoxins are determined by USP <85> with a limit calculated from the maximum intended bolus dose; typical parenteral-grade lanolin oil is specified with endotoxins below 0.5 EU/mL for intramuscular products. The oil vehicle is evaluated for particulate matter by USP <788> light obscuration after dilution with a suitable organic diluent because the native oil exceeds the viscosity limit of the method. Viscosity at 25°C is controlled between 80 mPa·s and 200 mPa·s by the lanolin oil fraction; higher viscosity delays injectability through a 21-gauge needle and increases patient discomfort. Sensitization potential is a critical limitation; the free wool alcohol fraction should be below 3.0% w/w to reduce the risk of hypersensitivity reactions, and a patch test or skin-prick evaluation is required in early clinical screening for any new depot formulation. The final injectable is filled into amber glass vials under nitrogen and stored between 2°C and 8°C; freeze-thaw cycling is avoided because lanolin oil can separate from the co-solvent at temperatures below 0°C. Published industrial data for lanolin oil in parenteral depots is limited; each formulation is screened for local tolerance in animal models before clinical evaluation.
Top-spray fluidized-bed coating with lanolin oil pharma grade provides a hydrophobic barrier on oral granules at coating levels of 2–5% w/w. The coating liquid is preheated to 45–50°C and sprayed through a two-fluid nozzle with atomizing air at 1.5–2.5 bar. Inlet air temperature is set at 50–60°C, yielding a product temperature of 40–45°C; this window keeps the oil sufficiently fluid to coalesce on the granule surface without leaking into the core. Coated granules are dried for 10–15 min after spraying and then cooled to room temperature before filling into sachets or capsules. Moisture uptake is measured by exposing the coated granules to 75% RH at 25°C for 24 h; batches are accepted when the moisture gain is below 2.0% w/w compared to uncoated controls. The barrier performance is sensitive to coating thickness; levels below 2.0% w/w produce incomplete film coverage and allow moisture ingress, while levels above 5.0% w/w cause granule agglomeration during fluidization and block the distributor plate. Coated granule flow is assessed by USP <1174> bulk density and angle of repose; angle of repose above 40° indicates insufficient surface dryness and may require a 0.5% w/w fumed silica post-mix.
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Lanolin Oil Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is a refined liquid wool wax fraction obtained from pharmaceutical-grade anhydrous lanolin by fractional crystallization, vacuum distillation, and high-depth filtration. The model designation refers to the oral and injectable control profile rather than a single molecular entity; the predominant CAS registration used for lanolin oil is 70321-63-0. The product consists mainly of high-molecular-weight esters of lanolin fatty acids with sterols, lanosterol derivatives, and triterpene alcohols. It is not a formulated excipient blend, a synthetic ester, or a hydrocarbon oil. Typical release control includes kinematic viscosity at 40 °C in the range 45 mm²/s to 75 mm²/s, iodine value between 20 g I₂/100 g and 30 g I₂/100 g, and water content not more than 0.25%. These values distinguish the oil from technical lanolin fractions, which may carry higher free fatty acid loads, lower filtration clarity, and uncontrolled oxidation products.
Batch traceability is maintained from the starting wool grease lot through each processing step. The oil is filtered through 0.45 µm polypropylene depth media before final packaging. For injectable-grade material, a second membrane filtration step at 0.22 µm is used under nitrogen pressure. This does not render the product sterile; it reduces bioburden and particulate load for downstream aseptic processing or terminal treatment. Because lanolin oil contains unsaturated sterol esters and minor natural antioxidants, exposure to oxygen and light must be controlled. Storage in tightly closed stainless-steel or glass-lined vessels under nitrogen is recommended below 25 °C, with headspace oxygen typically kept below 5 vol%.
Because a separate monograph for liquid lanolin oil is not uniformly harmonized across all pharmacopoeias, release specifications are anchored to the anhydrous lanolin monograph test battery and extended by low-temperature rheology. Acid value is determined by Ph. Eur. 2.5.1 or USP <401> and is commonly specified at not more than 1.0 mg KOH/g for injectable applications. Peroxide value is measured by iodometric titration according to Ph. Eur. 2.5.5; oral-grade material may be released at ≤10.0 meq O₂/kg, while injectable-grade material is typically tightened to ≤5.0 meq O₂/kg because higher peroxide loads accelerate oxidation of the sterol ester fraction during terminal processing. Saponification value by Ph. Eur. 2.5.6 is generally controlled between 90 mg KOH/g and 110 mg KOH/g. Water content is measured by Karl Fischer titration using Ph. Eur. 2.5.12; the limit of not more than 0.25% prevents hydrolytic free fatty acid formation during long-term storage.
| Attribute | Method standard | Oral-grade limit | Injectable-grade limit | Unit |
|---|---|---|---|---|
| Acid value | Ph. Eur. 2.5.1 | ≤1.5 | ≤1.0 | mg KOH/g |
| Peroxide value | Ph. Eur. 2.5.5 | ≤10.0 | ≤5.0 | meq O₂/kg |
| Saponification value | Ph. Eur. 2.5.6 | 90–110 | 90–110 | mg KOH/g |
| Water content | Ph. Eur. 2.5.12 | ≤0.25 | ≤0.25 | % |
| Residual solvents | USP <467> / Ph. Eur. 2.4.24 | pharmacopoeial | pharmacopoeial | — |
| Elemental impurities | ICH Q3D / USP <232> | risk-based | risk-based | µg/g |
| Bacterial endotoxins | Ph. Eur. 2.6.14 | not routinely assigned | finished-product limit | EU/mL |
For injectable development, the endotoxin limit is assigned from the maximum intended dose and finished-product volume; the bulk oil is not automatically suitable for injection without dosage-form validation. Because lanolin oil contains natural sterol antioxidants, oxidative stability cannot be inferred from fatty acid saturation alone. Formulators should not replace forced-degradation data with specifications alone, particularly when the oil is combined with unsaturated vegetable oils or oxygen-sensitive actives.
Moist-heat sterilization of bulk lanolin oil is not straightforward. The sterol ester fraction is sensitive to steam exposure, and the possible hydrolysis of lanolin fatty acid esters can raise the free fatty acid content during autoclaving at 121 °C for 15 min. In addition, dissolved oxygen reacts with unsaturated sterol moieties and increases peroxide value. Published data for this specific configuration is limited, and manufacturers are advised to perform feasibility studies under nitrogen headspace rather than assume the oil behaves like a fully saturated parenteral vehicle. Aseptic filtration through 0.22 µm membranes at 35–40 °C after pre-warming is commonly used for injectable-grade handling. If terminal sterilization is unavoidable, the container headspace oxygen amount and the cooling phase duration must be controlled; slow cooling in partially filled vessels can accelerate oxidation because the oil remains hot while oxygen remains available.
The formulation boundary is not only microbiological but chemical. The oil should not be mixed with strong alkalis or oxidizing agents, and addition to aqueous emulsions without an antioxidant can generate peroxide by-products during storage. Containers should be resealed under nitrogen after each partial withdrawal. At relative humidity above 60%, vented containers should be avoided because repeated opening can introduce moisture that slowly hydrolyzes ester bonds, particularly if free water condenses on the headspace wall.
For oral granule production, the oil is sprayed at 35–40 °C through a heated two-fluid nozzle onto a pre-warmed powder bed of lactose, microcrystalline cellulose, or dibasic calcium phosphate. The powder bed is maintained at 25–30 °C to avoid wax solidification on droplet surfaces. On production-scale high-shear granulators of approximately 600 L, impeller speeds from 120 rpm to 250 rpm and chopper speeds from 800 rpm to 1500 rpm are typical, but the critical parameter is oil addition rate. At addition levels above 5 wt%, the liquid can seal binder-soluble water out of granules and change granule size rapidly. Above 8 wt%, wet mass adhesion to bowl surfaces and chopper blades becomes a practical batch-release problem. The material is therefore used as a secondary hydrophobic granulation aid at 2–5 wt%, not as a primary aqueous binder. At these levels, tablet ejection force is reduced, but the oil is not a direct replacement for magnesium stearate because it remains a liquid at compaction temperature and can accumulate on die walls if spray distribution is uneven.
In tablet development, the effect of lanolin oil on dissolution must be checked against USP <711>. Hydrophobic film formation on granules can delay release for poorly soluble actives, particularly when the oil level exceeds 3 wt% in high-shear formulations. If dissolution drops below the target, the oil is either reduced or added as a pre-emulsified mixture with a surfactant such as polysorbate 80. This is a formulation-specific adjustment, not a universal property of the oil.
In oil-based depot formulations, lanolin oil may be added to benzyl alcohol or benzyl benzoate to modify the viscosity and polarity of the vehicle. The mixture is not a simple solvent system; benzyl alcohol can increase the polarity of the oil phase, while benzyl benzoate can shift the viscosity downward. Because lanolin oil contains free sterols and high-molecular-weight esters, addition levels from 5% to 15% can produce a measurable increase in vehicle viscosity compared with the pure aromatic ester. The mixture should be evaluated by rotational viscometry at 25 °C and by capillary viscometry at 40 °C using ISO 3104 or ASTM D445. Syringeability through 21-gauge or 22-gauge needles is then assessed with the final oil phase, because viscosity data alone does not predict injection force.
Injectable use requires that the incoming lanolin oil meet parenteral bioburden, endotoxin, particulate, and oxidation controls. The oil should not be regarded as an injectable vehicle solely because it is of low acid value; the dosage form must be sterile-filtered or aseptically prepared, and the final product must meet sterility testing according to Ph. Eur. 2.6.1. Sub-visible particle counts are evaluated by Ph. Eur. 2.9.19 or equivalent pharmacopoeial method. If the depot contains a heat-labile active, filtration and aseptic processing are preferred over terminal sterilization of the finished oil because the sterol esters can oxidize during the heating cycle.
Lanolin oil differs from anhydrous lanolin mainly in physical state and wax content. Anhydrous lanolin is semi-solid at room temperature and requires melting before transfer; lanolin oil remains pourable at 25 °C and can be handled through jacketed vessels at 35–40 °C. Compared with medium-chain triglycerides, lanolin oil has higher viscosity and lower oxidative stability because of its sterol ester fraction. Compared with light liquid paraffin, lanolin oil is more polar and can interact with polar actives, but it is less suitable when a fully saturated hydrocarbon is required for stability. Compared with synthetic esters such as ethyl oleate, lanolin oil is a complex natural mixture with lot-to-lot compositional variation; this variation is controlled by release limits but cannot be eliminated at the molecular level.
| Property | Lanolin Oil Pharma Grade | Anhydrous Lanolin | Medium-chain Triglycerides | Light Liquid Paraffin |
|---|---|---|---|---|
| Physical state at 25 °C | Pourable liquid | Semi-solid | Liquid | Liquid |
| Kinematic viscosity at 40 °C | 45–75 mm²/s | not applicable until melted | 25–33 mm²/s | 12–20 mm²/s |
| Acid value | ≤1.0 mg KOH/g | ≤1.0 mg KOH/g | ≤0.2 mg KOH/g | ≤0.1 mg KOH/g |
| Oxidative susceptibility | moderate; iodine value 20–30 g I₂/100 g | moderate | low | very low |
| Parenteral status | injectable grade after validation | not used directly | pharmacopoeial parenteral grade available | parenteral grade available if specification is met |
| Main compositional feature | sterol esters and triterpene alcohol esters | wool wax esters with higher melting point | caprylic/capric triglyceride mixture | saturated hydrocarbons |
The difference that most affects tablet and capsule processing is not polarity alone but temperature-dependent flow. Lanolin oil can be drained from drums at 18–20 °C, but process lines should still be heated to prevent viscosity increase in long transfer runs. In direct capsule filling, a heated hopper is set at 30–35 °C and the oil is delivered by a lobe pump to a volumetric filling needle. Capsule shells should be checked for softening because the free sterol fraction can migrate into gelatin under accelerated storage at 40 °C and 75% relative humidity. Capsule fill weight variation below ±2% is achievable when the oil temperature is held within a narrow band, but start-up periods require line stabilization before weight sorting begins. If the oil cools below its wax cloud point, partial crystallization can block the filling needle and produce variable fill weights; this failure mode is observed more frequently with lanolin oil than with fully saturated vehicles such as medium-chain triglycerides.
When the oil is used in granules intended for sachets or tablets, cleaning of production equipment must account for its hydrophobic residue. Isopropanol or warm acetone is more effective than water alone. Residual oil on granulator walls increases the risk of cross-contamination and changes the surface energy of the next batch. Dedicated transfer lines or validated cleaning procedures are therefore required. If the formulation contains oxygen-sensitive components, nitrogen blanketing after granulation is recommended and the granule water activity should be monitored before packaging. The material is not a universal substitute for simple oils; it is selected when the formulation requires a complex lipophilic matrix with sterol-associated solvency and controlled oxidation potential.
