| HS Code | 612412 |
| Chemicalname | Lanolin Anhydrous |
| Casnumber | 8006-54-0 |
| Description | Purified, semi-solid, yellowish-white anhydrous waxy material obtained from sheep wool, with a faint characteristic odor |
| Solubility | Insoluble in water; sparingly soluble in alcohol; freely soluble in ether and chloroform; soluble in acetone and hot fat solvents |
| Meltingpoint | 36.0 - 42.0 degree Celsius |
| Saponificationvalue | 80.0 - 120.0 mg KOH per gram |
| Iodinevalue | 18.0 - 36.0 g of iodine per 100 g |
| Pharmacopoeiagrade | Suitable for use as a pharmaceutical ingredient in oral and injectable dosage forms such as tablets, capsules, granules and injections |
As an accredited Lanolin Anhydrous 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 | Supplied in 25 kg sealed, double-poly-lined drums, ensuring purity and stability for oral, injectable, and granule formulations. |
| Container Loading (20′ FCL) | 20′ FCL loaded with palletized drums of Lanolin Anhydrous Pharma Grade API, safely secured and sealed for oral/injectable pharmaceutical use. |
| Shipping | Lanolin Anhydrous Pharma Grade API is shipped in sealed, moisture-proof, food-grade containers to maintain purity and stability. Transport under cool, dry conditions, protected from direct sunlight and contamination. Documentation includes certificates of analysis and compliance with pharmaceutical regulations for oral and injectable use. |
| Storage | Store Lanolin Anhydrous Pharma Grade API in a tightly closed, inert container in a cool, dry, well-ventilated area, protected from light, moisture, and excessive heat. Maintain controlled room temperature (20–25°C) and avoid contact with oxidizing agents. Ensure container integrity to prevent contamination. Keep away from incompatible materials. Suitable for oral and injectable dosage forms when handled under hygienic conditions. |
| Shelf Life | Shelf Life: 36 months from manufacture when stored tightly closed, protected from light/moisture, at controlled room temperature. |
Moisture-sensitive tablet APIs that cannot tolerate aqueous granulation are occasionally processed by melt granulation using a lipid binder. Anhydrous lanolin of pharmacopoeial grade is defined by a melting range of 38–44°C and a water absorption capacity of ≥200% under PhEur monograph 0134; these properties allow the material to be added as a liquid binder at moderate temperature and then solidified by cooling. In a high-shear granulator with a jacketed vessel set to 50–60°C and an impeller tip speed below 3 m/s, lanolin anhydrous is typically evaluated at 2–5% w/w of the dry powder mass. The molten phase coats individual particles but does not form a continuous aqueous film; after cooling below 35°C, the granules become free-flowing without a drying step. This process is particularly relevant when the active substance is hydrolytically unstable and the formulation cannot accept starch paste or povidone solution. The PhEur monograph also imposes an acid value limit of ≤1.0, a peroxide value limit of ≤20 meq/kg, and a saponification value range of 90–105; each of these limits must be verified on the specific lot because residual free acids and peroxides can degrade oxygen-sensitive APIs. For granule size reduction, an oscillating sieve mill fitted with a 1.0–1.5 mm screen is used after cooling; screen blinding has been observed when the lanolin binder fraction exceeds 6% w/w because frictional heat during milling re-melts the lipid phase. On a rotary tablet press, compaction forces between 10–25 kN produce tablets whose tensile strength is reduced by the hydrophobic binder layer; disintegration behaviour therefore diverges from conventional wet-massed granules. Since published formulation data for this exact configuration are limited, development work should compare granule size distribution by USP <786> and dissolution profiles by USP <711> before transfer to scale-up.
| Pharmacopoeial Parameter | PhEur 0134 Limit | Relevance to Solid Oral Dosage |
|---|---|---|
| Acid value | ≤1.0 | Controls free fatty acids that affect capsule shell integrity |
| Peroxide value | ≤20 meq/kg | Oxidation-labile APIs require lower in-house limits, typically ≤5 meq/kg |
| Saponification value | 90–105 | Index of ester chain length; influences melt viscosity |
| Melting range | 38–44°C | Determines hot-melt granulation and capsule fill temperature |
| Water absorption | ≥200% | High uptake capacity excludes aqueous bulk mixing |
| Loss on drying | ≤0.5% | Residual moisture affects powder flow and granule stability |
| Residue on ignition | ≤0.15% | Limits inorganic residues in oral solid dosage forms |
Hard gelatin and HPMC capsule shells require semi-solid fill masses with controlled yield stress to prevent leakage at the cap–body joint. Anhydrous lanolin can be combined with medium-chain triglycerides or soya bean oil to produce a thixotropic fill vehicle; the lipid phase is prepared in a jacketed vessel heated to 45–55°C and dispersed by a rotor–stator homogeniser operating at 5,000–10,000 min−1. The molten mass is then cooled to 30–32°C under low-shear agitation before transfer to the encapsulation machine. Capsule filling must respect the thermal deformation threshold of the shell; gelatin shells soften above 40°C at equilibrium, whereas HPMC shells are more tolerant to temperature but more sensitive to fill moisture. Because lanolin anhydrous consists primarily of sterol esters and wax alcohols rather than triglycerides, the fill displays non-Newtonian shear-thinning behaviour, and no harmonised pharmacopoeial yield-stress specification exists for this application. Published data for this specific configuration is limited, so product-specific leakage tests under USP <1207> are required. Oxidative stability is a critical boundary: the fill must be blanketed with nitrogen during manufacture, and the peroxide value should be controlled below 5 meq/kg when the capsule contains oxidation-sensitive actives, which is significantly tighter than the general PhEur lanolin limit of ≤20 meq/kg. Residual moisture in the fill must also be measured by Karl Fischer titration, and the result must not exceed the equilibrium moisture specification of the capsule shell, otherwise embrittlement or softening can occur during storage.
Fluid-bed coating of granules with lanolin anhydrous is not a standard aqueous operation because the material absorbs at least 200% of its own weight in water and forms a viscous inverse phase. Organic-solvent coating is used instead, with a solution containing 10–20% w/w lanolin in anhydrous ethanol or isopropanol. The spray line and nozzle must be heated to 35–40°C to prevent precipitation of the wax as the solvent cools during atomisation. In a Wurster coater fitted with a 0.8–1.2 mm spray nozzle and a partition gap of 5–10 mm, inlet air is held at 40–50°C; these conditions produce a hydrophobic surface layer on the granules without promoting agglomeration. Lanolin does not form a continuous film when used alone; it functions as a plasticising or swelling modifier when combined with ethylcellulose or polymethacrylate latex. At addition levels above 15% w/w relative to the polymer, the sprayed films become tacky and the Wurster tube accumulates static and partially fused granules. Aqueous dispersions are incompatible with the material because the water-absorption capacity of lanolin changes the rheology and retards evaporation. After coating, residual solvent must be tested according to USP <467>, and dissolution release profiles must be compared with the uncoated granule using USP <711>. Powder flow and bulk density of the coated granules should be recorded under USP <616>; surface hydrophobicity can improve flow, but fine-particle adhesion to larger cores may reduce bulk density.
Lanolin anhydrous is not listed as a parenteral excipient in the major pharmacopoeias, and the absence of a harmonised monograph for injectable use means that any injectable formulation would require a full safety qualification rather than routine master formula use. The allergen profile of wool wax alcohols and the possible carryover of wool-scouring detergents or pesticides remain the dominant safety constraints; these impurities must be controlled below regional acceptance thresholds under ICH Q3C for residual solvents and ICH Q3D for elemental impurities. Injectable use would also require a bacterial endotoxin limit, typically 0.5 EU/mg or lower for raw materials intended for parenteral products, but no compendial endotoxin limit exists for lanolin anhydrous and the supplier must establish a validated limit. Sterilisation routes are restricted: dry heat above 160°C accelerates peroxide formation and darkens the material, gamma irradiation at 25 kGy may generate free radicals that alter the oxidative state, and moist heat is not suitable for a hydrophobic anhydrous wax. If filter sterilisation were attempted, the material would need to be processed as a molten liquid and passed through a 0.22 µm membrane, but its viscosity at processing temperatures makes this operationally impractical at production scale. Terminal sterilisation of a lanolin-containing formulation is also constrained by melting and phase separation above 45°C. Published data for injectable lanolin anhydrous is limited, and the technical boundary therefore excludes most injectable and oral API claims unless the applicant provides a substance-specific toxicological and sterility data package.
Direct compression of hygroscopic actives may evaluate anhydrous lanolin as an internal lubricant at 0.5–1.5% w/w because the waxy solid can reduce die wall friction without requiring aqueous granulation. The material is first screened through a 250 µm mesh to eliminate agglomerates, then blended with the powder mixture in a V-blender at 25 rpm for 15–20 min. Over-blending beyond 30 min should be avoided because the frictional energy can smear the wax onto the punch faces and cause filming during compression. An instrumented rotary press records lower ejection force in lanolin-containing blends, but compact hardness is reduced due to the hydrophobic lubricant layer on the particle surfaces. The disintegration and dissolution changes must be quantified by USP <701> and USP <711> because the waxy barrier can delay wetting of the tablet matrix. Published data for lanolin as a tablet lubricant is limited; the material is not a like-for-like replacement for magnesium stearate, and a standard lubricant screening study under USP <1062> should be used to compare ejection force, tensile strength, and dissolution onset.
For multiparticulate cores intended for pulsatile or delayed release, anhydrous lanolin can function as a hydrophobic matrix modifier when applied by hot-melt coating or incorporated into the core by melt mixing. The material is combined with glyceryl dibehenate or hydrogenated vegetable oil at a ratio of 1:3 to 1:5 in a jacketed mixer at 55–65°C, and the drug-loaded pellets are produced by extrusion–spheronisation before cooling. The low melting fraction improves the extrusion mass plasticity below 45°C, but the pellet surface becomes glossy and less porous, which delays water penetration. To control release, the core must be tested by USP <711> dissolution at multiple pH conditions, because the hydrophobic matrix is sensitive to surfactant concentration in the dissolution medium. Scanning electron microscopy of the pellet cross-section is recommended to verify that the lanolin phase is distributed rather than phase-separated at the surface. Residual peroxide and acid value must be rechecked after the hot-melt stage because exposure to oxygen at processing temperature can increase oxidative degradation; lots with an initial peroxide value above 10 meq/kg should not be used for oxygen-sensitive actives. The final multiparticulate dosage form may be filled into hard capsules or compressed into tablets after the addition of an external disintegrant, but compression force should not exceed 15 kN to avoid deformation of the waxy pellets and subsequent dose dumping.
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Lanolin Anhydrous Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is a purified wool wax supplied under pharmacopoeial monograph control. The commercial identification uses the full product designation as the specification model, because the grade is defined by the current European Pharmacopoeia monograph 0134 (Wool fat) and, where dual release is requested, by the USP-NF Lanolin monograph. The substance is listed under CAS 8006-54-0. Lanolin anhydrous is not a single chemical entity but a complex mixture of sterol esters, triterpene alcohol esters, hydroxy fatty acid esters, and free alcohols. The material is semi-solid at 15–25 °C, with a dropping point of 38–44 °C; it is therefore classified as a waxy lipophilic excipient or vehicle in most regulatory submissions. The phrase “Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable” identifies a multi-route specification category, but route-specific release criteria remain mandatory. Oral solid use requires moisture, acid, peroxide, and microbial control; injectable use requires additional bacterial endotoxin, sterility, particulate matter, and sensitization-risk assessment.
In this material, the controlling variables differ between solid oral and injectable applications. Residual water is limited to ≤ 0.25% w/w in the anhydrous grade, which is the key differentiation from hydrous lanolin and prevents hydrolysis of moisture-sensitive actives during hot-melt processing. Acid value is limited to ≤ 1.0 mg KOH/g because free fatty acids can react with basic drug substances and shift the thermal behavior of the melt. Peroxide value, limited to ≤ 20 meq O₂/kg by the monograph, is the primary oxidative-stability indicator; many pharmaceutical users tighten the internal limit to ≤ 5.0 meq O₂/kg for oxygen-sensitive APIs. Hydroxyl value between 22 and 35 mg KOH/g reflects free lanolin alcohols, which contribute to water-in-oil interfacial activity but also increase sensitization potential. Saponification value between 90 and 105 mg KOH/g distinguishes lanolin from simple hydrocarbons such as white petrolatum. Residue on ignition ≤ 0.1% w/w limits inorganic impurities. For any route, these values should be read against the specific release monograph stated on the certificate of analysis.
In production-scale solid oral processing, lanolin anhydrous is introduced as a molten binder at 45–55 °C. The melt is prepared in a jacketed vessel under nitrogen blanket and transferred through heated lines to a high-shear granulator or top-spray fluid-bed granulator. Temperature control at ± 2 °C around the set point is required because partial solidification below the 38–44 °C dropping point creates non-uniform binder distribution. Twin-screw granulator configurations with heated zones set to 42–48 °C are feasible, but published data for this specific lanolin anhydrous configuration is limited; therefore, thermal mapping and granule size distribution qualification are necessary before scale-up. At binder levels of 5–15% w/w, the waxy melt can agglomerate fine powders into free-flowing granules, but the hydrophobic nature of lanolin can extend tablet disintegration time. Disintegration is monitored according to USP <701>; dissolution is characterized using USP <711> Apparatus II at 50 or 100 rpm. For capsule filling, granules should be cooled below 30 °C before transfer to automatic two-piece capsule machines because tackiness at higher temperatures causes binder accumulation on dosator pins and tamping disks. Milling through a 1000 µm screen at 25–30 °C reduces oversized waxy agglomerates. Bulk density of the milled granulate is typically 0.40–0.65 g/cm³ depending on drug and filler; compressibility index should be below 25%. Tableting is performed on rotary presses with precompression, and tooling temperature should be maintained below 35 °C to prevent sticking. If sticking occurs, press speed should be reduced and external lubrication with magnesium stearate 0.25–0.5% w/w evaluated.
The dropping point range of 38–44 °C specified by Ph. Eur. 2.2.17 is a critical thermal boundary. Because lanolin anhydrous is not a sharp-melting pure compound, viscosity changes gradually near the lower threshold and is influenced by temperature, shear history, and free alcohol content. Online viscosity measurement is therefore more informative than a single release value. Molten material held at 50 °C should be rechecked for peroxide value after extended holding, and recirculation should not exceed the thermal exposure validated by the supplier. Nitrogen overlay is required when the melt is held for more than a few hours. Feed lines and spray nozzles should be heated and insulated to prevent solidification; production-scale failure modes observed on manufacturing lines include nozzle blockage when heat tracing fails and peroxide increase when product is held in open heated vessels. In injectable processing, molten lanolin requires filtration through a heated pre-filter and then a 0.22 µm sterilizing-grade membrane. Viscosity at 45 °C may reduce membrane throughput; differential pressure across the final filter should be monitored to avoid exceeding the filter manufacturer’s maximum operating pressure.
For injectable dosage forms, lanolin anhydrous is not a conventional aqueous parenteral vehicle. It may be considered only as a minor lipophilic structuring component in non-aqueous depot or oil-based formulations after purification and route-specific qualification. The finished injectable must meet sterility according to USP <71> or Ph. Eur. 2.6.1, bacterial endotoxin limits according to USP <85> or Ph. Eur. 2.6.14, and particulate matter according to USP <788> or Ph. Eur. 2.9.19. Endotoxin limits must be derived from the intended clinical dose; a raw-material limit of ≤ 2.5 EU/g is commonly applied for low-endotoxin lipids, but compendial lanolin does not automatically carry this release test. The sensitizing potential of free wool alcohols must be addressed in the formulation development report. If the proposed injectable concentration cannot be toxicologically justified, a semi-synthetic alternative should be selected. Published data for injectable lanolin anhydrous in commercial parenteral products is limited; accordingly, formulation and regulatory acceptability require supplier-supported purification studies and extractables profiling.
The main difference from hydrous lanolin is water content: hydrous lanolin contains 25–30% w/w purified water, whereas anhydrous lanolin contains not more than 0.25% w/w. Replacement therefore removes a water internal phase and changes formulation rheology; if a water-in-oil emulsion is intended, the removed water must be restored separately or the formulation must be redesigned as an anhydrous ointment or wax matrix. Against white petrolatum, lanolin anhydrous offers ester and free alcohol functionality, so it can promote water uptake and interfacial activity that petrolatum cannot provide. White petrolatum has negligible acid, hydroxyl, and saponification values and is chemically inert; anhydrous lanolin is more polar and more prone to oxidative degradation. Lanolin alcohols, a fractionated derivative, have higher free alcohol content and stronger emulsifying character but increased sensitization potential. Hydrogenated lanolin has a higher dropping point and greater oxidative stability, making it preferable when processing must exceed 60 °C. Lanolin oil, the liquid fraction, differs from anhydrous lanolin in dropping point and viscosity and is selected when a liquid lipophilic carrier is required. In solid oral dosage forms, substitution of hydrous lanolin by the anhydrous grade may not require major changes because the 25–30% water absent in the anhydrous product is often not part of the granulating fluid; however, if hydrous lanolin had been used as an emulsion binder, the binder phase consistency will change.
Natural wool wax shows batch-to-batch variation in ester distribution, free alcohol content, and color. Release testing should therefore rely on the pharmacopoeial matrix of acid, hydroxyl, saponification, peroxide, water, and dropping point rather than on a single identification parameter. Clear batch-to-batch shifts can occur with wool source and refining process. The most commonly observed production-scale failure is rising peroxide value in partially used drums. Sampling should be performed after homogenization of the drum at 40–45 °C, and peroxide value should be rechecked before each campaign. Color, if required, is controlled by a supplier-specific scale; excessively dark product may indicate oxidative damage. Residual solvents are not normally present because lanolin is obtained by wool scouring and purification, but suppliers should provide a statement of extraction solvent residues if the product is intended for injectable applications. The product should be manufactured under current good manufacturing practice. For drug-substance classification, ICH Q7 applies; for excipient classification, excipient GMP guidelines apply. Documentation should include TSE/BSE risk per EMA/410/01 Rev. 3, elemental impurity assessment under ICH Q3D, and residual solvent assessment under ICH Q3C if applicable.
Storage requires protection from light, air, and humidity. Sealed epoxy-lined steel drums or stainless steel containers with nitrogen overlay maintain peroxide value and water content. Bulk storage temperature should remain between 15 and 25 °C; cold storage below 15 °C is acceptable but requires rewarming to 40–45 °C before discharge. The product should not be held in open heated vessels beyond the validated period, and recirculation loops should be designed with heated jackets and minimum dead legs. Incompatibilities include strong oxidizing agents, strong alkali, and primary-amine drug substances under heated conditions because ester hydrolysis and amidation can occur. Contact with iron or copper at elevated temperature can accelerate rancidity; stainless steel 316L or glass-lined equipment is recommended.
The following matrix summarizes the compendial release tests used to define the anhydrous grade. Limits shown are representative of the Ph. Eur. wool fat monograph and USP-NF lanolin; the release monograph must be identified on the certificate of analysis because the compendia are not harmonized.
| Parameter | Ph. Eur. method | USP-NF method | Representative limit |
|---|---|---|---|
| Water content | Ph. Eur. 2.5.12 | USP <921> method Ia | ≤ 0.25% w/w |
| Acid value | Ph. Eur. 2.5.1 | USP <401> | ≤ 1.0 mg KOH/g |
| Peroxide value | Ph. Eur. 2.5.5 | USP <401> | ≤ 20 meq O₂/kg |
| Saponification value | Ph. Eur. 2.5.6 | USP <401> | 90–105 mg KOH/g |
| Hydroxyl value | Ph. Eur. 2.5.3 | USP <401> | 22–35 mg KOH/g |
| Residue on ignition | Ph. Eur. 2.4.16 | USP <281> | ≤ 0.1% w/w |
| Dropping point | Ph. Eur. 2.2.17 | USP <741> | 38–44 °C |
The route-specific compliance matrix identifies additional tests applied to the raw material before use in oral solid manufacture or injectable formulation development.
| Microbiological attribute | Oral solid dosage | Injectable dosage |
|---|---|---|
| Microbial enumeration | USP <61> / Ph. Eur. 2.6.12: TAMC ≤ 10³ CFU/g, TYMC ≤ 10² CFU/g | Bioburden controlled before sterilization; same compendial methods may apply |
| Specified organisms | USP <62> / Ph. Eur. 2.6.13: absence of Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus | Same absence criteria |
| Sterility | Not required for nonsterile solid oral | USP <71> / Ph. Eur. 2.6.1 |
| Bacterial endotoxins | Not routinely applied | USP <85> / Ph. Eur. 2.6.14; limit derived from clinical dose |
| Particulate matter | Not required | USP <788> / Ph. Eur. 2.9.19 |
For tablet and capsule applications, lanolin anhydrous should be regarded as a hot-melt binder and hydrophobic matrix component rather than a direct-compression filler. For granule manufacturing, the finished granulate should be tested for bulk density and tapped density according to USP <616>, and powder flow should be characterized by Carr index and Hausner ratio according to USP <1174>. The material is not compatible with all polymers: it can plasticize certain methacrylates at elevated temperature and should not be premixed with acid-labile drugs without compatibility data. In every case, the exact route-specific acceptance criteria must be attached to the batch record and the certificate of analysis; a single monograph release does not automatically satisfy oral and injectable requirements.
