| HS Code | 433910 |
| Product Name | Liduo Powder Veterinary Grade API |
| Api Grade | Veterinary Grade |
| Physical Form | Fine powder |
| Color | White to off-white crystalline powder |
| Odor | Characteristic or odorless depending on batch |
| Solubility | Soluble in suitable pharmaceutical solvents and aqueous media as per formulation |
| Active Ingredient | Liduo (veterinary active pharmaceutical ingredient) |
| Purity | ≥98% assay on dried basis |
| Primary Applications | Manufacture of tablets, injections, capsules, powders, granules, premix, and solutions |
| Target Species | Livestock, poultry, swine, and companion animals |
| Storage Conditions | Store in a cool, dry, well-ventilated area protected from light and moisture |
| Shelf Life | 24 months from date of manufacture when stored under proper conditions |
| Packaging Type | Sealed polyethylene-lined drums or laminated bags |
| Regulatory Status | Complies with veterinary API standards for pharmaceutical compounding |
| Handling Precautions | Use with appropriate personal protective equipment; avoid inhalation and contact with skin |
As an accredited Liduo Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Liduo Powder veterinary grade API is packaged as 25 kg net weight in sealed aluminum-lined polyethylene bags inside fiber drums. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Liduo Powder veterinary API: packed in sealed drums, palletized, secured for safe transport. |
| Shipping | Liduo Powder (Veterinary Grade API) is shipped as a sealed, moisture-protected powder in multilayer bags inside fiber drums or aluminum foil pouches. Transport under dry, ventilated, temperature-controlled conditions. Ensure secure containment, clear labeling, and complete documentation for veterinary raw material compliance. Protect from light, heat, and physical damage during transit. |
| Storage | Store Liduo Powder (veterinary-grade API) in tightly sealed, original containers in a cool, dry, well-ventilated area, protected from light, moisture, and direct sunlight. Keep away from incompatible substances and food. Maintain temperatures between 15–30°C, avoid humidity above 60%, and ensure containers remain firmly closed after use. |
| Shelf Life | Shelf Life: 24 months from manufacture date when stored in original, tightly sealed containers, protected from moisture, heat, and direct sunlight. |
Liduo Powder is loaded at 20.0 g/L into a 316L stainless-steel jacketed vessel with PTFE scraper blades and a top-entry agitator to manufacture a 2% w/v lidocaine hydrochloride injection for infiltration, nerve block, and epidural use in cattle, sheep, pigs, and horses. Sodium chloride is added at 6.0 g/L for isotonicity, and the batch is dispersed in Water for Injections at 35±2°C under 0.5 L/min nitrogen sparging. The pH is adjusted to 5.6±0.4 with 0.1 M hydrochloric acid or 1 M sodium hydroxide before volume adjustment. The solution is filtered through a 0.2 μm PES filter and filled into 100 mL amber Type II glass vials with bromobutyl stoppers. Terminal sterilization is performed in a saturated steam autoclave at 121.1°C ±0.5°C for 15 min with F0 ≥ 12; validation probes are placed in the slowest-to-heat point of each tray. Holding time from dissolution to sterilization is limited to 4 h at 20-25°C because 2,6-xylidine formation and free-base precipitation are pH- and temperature-dependent. For food-producing species, current residue documentation is required under Commission Regulation (EU) No 37/2010 for target species with an approved listing or equivalent national registration, and residue depletion methods are validated according to VICH GL49. In the US, extralabel use in food animals is subject to 21 CFR 530.41 and AMDUCA. Sterility assurance follows Ph. Eur. 5.1.1 and USP <1>. The finished terminal product is 20 mg/mL lidocaine hydrochloride injection in 100 mL or 250 mL amber Type II vials.
High-strength solutions of 4% w/v and 10% w/v are prepared for topical anesthesia of nasal, oral, and laryngeal mucosa in large animals and for small-volume infiltration where a concentrated product is requested. The 10% w/v formulation is manufactured without sodium chloride because the high API concentration already produces a hypertonic solution; the dissolution step is run at 35±2°C and the pH is held between 5.0 and 5.5 before filtration. At 25°C, lidocaine base has a pKa of 7.8; a pH shift above 6.5 can deprotonate the hydrochloride salt and create a visible precipitate in the filling line. Sterilization is retained as 121.1°C ±0.5°C for 15 min rather than longer cycles because 2,6-xylidine, the primary hydrolytic degradation product, increases with both pH and time at elevated temperature. Batches are filled into 10 mL amber Type I glass vials for the 10% w/v strength and 100 mL Type II glass vials for the 4% w/v strength. Filter integrity testing is completed before steam loading, and post-sterilization pH is required to drift no more than 0.3 pH units from filtered bulk. A batch is rejected if visible particles are detected after autoclave discharge or if the 20 μm and 10 μm sub-visible counts exceed Ph. Eur. 2.9.19 limits. Equipment includes a water-spray autoclave with rotating basket and independent flexible thermocouples in the coldest load position. The finished terminal product is a 4% w/v solution in 100 mL multidose vials or 10% w/v solution in 10 mL single-dose vials.
| Parameter | 2% injectable | 4% topical solution | 10% topical solution |
|---|---|---|---|
| API concentration | 20.0 g/L | 40.0 g/L | 100.0 g/L |
| Sodium chloride | 6.0 g/L | None | None |
| pH at 25°C | 5.6±0.4 | 5.2±0.3 | 5.1±0.2 |
| Sterilization | 121.1°C for 15 min | 121.1°C for 15 min | 121.1°C for 15 min |
| Primary packaging | 100 mL Type II amber vial | 100 mL Type II amber vial | 10 mL Type I amber vial |
| Main processing threshold | Hold time ≤ 4 h before sterilization | pH ≤ 5.8 at filling | pH ≤ 5.5 at filling |
Lidocaine hydrochloride injection 20 mg/mL is produced as a preservative-free single-dose vial for intravenous loading and constant-rate infusion in dogs and cats with ventricular arrhythmias. Each 10 mL formulation contains 20.0 g/L API and 9.0 g/L sodium chloride in Water for Injections, with a final pH of 5.5-6.5. The manufacturing route uses 0.2 μm PES filtration, followed by terminal autoclave at 121.1°C ±0.5°C for 15 min; the stopper is a bromobutyl closure validated for nitrogen-headspace vials. Container-contact studies follow USP 1660 for glass inner-surface durability and USP 1664 for leachable profiling. During hospital preparation, the solution should not be mixed with sodium bicarbonate 8.4% w/v because the resulting pH shift above 7.0 can precipitate lidocaine base and reduce dosing accuracy. Infusion containers made from soft polyvinyl chloride may show formulation-dependent sorption over 24 h; when a constant-rate infusion must exceed 12 h, a polyethylene or polypropylene bag is selected unless PVC compatibility data from the bag supplier confirms lidocaine loss below 5% at 25°C. The finished vial is 20 mg/mL lidocaine hydrochloride injection in 5 mL, 10 mL, and 20 mL Type I clear glass presentations.
For equine upper-airway endoscopy and feline or canine tracheal intubation, the API is converted into non-sterile preserved solutions and sprays rather than injectable ampoules. A 2% w/v oromucosal solution is compounded with 0.01% w/v benzalkonium chloride, 0.6% w/v sodium chloride, and 0.5% w/v hydroxypropyl methylcellulose as a transient mucoadhesion aid. The pH is adjusted to 5.5-6.0 before filtration through a 0.45 μm polypropylene filter. Filling is performed under laminar airflow into 100 mL HDPE bottles fitted with 100 μL metered spray pumps; for 10% w/v spray application, a 20 mL amber glass bottle with an atomizer is used. Antimicrobial preservation effectiveness is demonstrated according to Ph. Eur. 5.1.3, and container closure integrity follows USP <660> for glass and plastic packaging. Terminal product examples include 2% w/v solution in 100 mL HDPE bottles and 10% w/v spray in 20 mL amber glass atomizers. The non-sterile route is acceptable only when the target mucosa is intact; open-wound irrigation or surgical-field application requires a sterilized product from the injectable manufacturing line.
Powders, granules, and diluent-ready premixes are produced by geometric trituration of milled lidocaine hydrochloride with lactose monohydrate or mannitol. The API is first milled to a particle-size distribution of D90 ≤ 75 μm using a stainless-steel hammer mill with a 0.3 mm screen, then blended in a twin-shell V-blender at 25 rpm for 20 min. A 1% w/w dusting powder for superficial wound margins and mucous membranes is made with sterilized talc base and packed into 50 g HDPE bottles; a 2% w/w granule for oromucosal retention is produced by wet granulation using 5% w/v povidone K30 solution and dried at 40±2°C to final moisture below 0.5%. A 2% w/w premix in lactose is filled into 25 kg fiber drums with double polyethylene liners as a starting intermediate for in-house veterinary dilution. Content uniformity acceptance value is set at AV ≤ 15 per Ph. Eur. 2.9.40, and powder flow is characterized by Carr index and Hausner ratio per USP 1174. The dry forms are manufactured at 20-25°C and 30-45% RH; high humidity above 60% RH increases surface moisture and may accelerate crystal bridging during storage. ICH Q1A accelerated stability at 40°C/75% RH is used to compare lactose and mannitol blends; mannitol is preferred for tropical distribution because lactose is a reducing carbohydrate and moisture-catalyzed interaction with amine-bearing compounds can discolor exposed powder. Terminal product specification includes 1% w/w dusting powder in 50 g HDPE bottles, 2% w/w granules in single-dose LDPE sachets, and 2% w/w premix in 25 kg fiber drums.
Systemic oral dosage forms of lidocaine are limited by extensive first-pass dealkylation; therefore tablet and capsule formats are confined to oromucosal retention and slow dissolution on gingival or buccal tissue. Human oral bioavailability is reported at approximately 35% due to first-pass N-dealkylation; veterinary extrapolation requires species-specific data. A 10 mg eroding tablet is prepared by direct compression with 10.0 mg API, 84.5 mg microcrystalline cellulose, 5.0 mg sodium carboxymethylcellulose, and 0.5 mg magnesium stearate, giving a total mass of 100 mg. The powder is compressed on a rotary press with 8 mm B-tooling at 6-10 kN, hardness is controlled to 4.0-8.0 kp, and friability is maintained below 1.0% per USP 1216. Disintegration is tested per Ph. Eur. 2.9.1 and should complete in 15-30 min at 37°C in simulated saliva. Dissolution is performed per USP 711 with 500 mL phosphate buffer pH 6.8 at 50 rpm; sampling at 15 min, 30 min, and 60 min is reported because no compendial veterinary monograph exists for this configuration. Hard gelatin capsules of 5 mg strength can be filled with a 5% w/w lidocaine HCl-lactose blend, but they are not recommended for swallowed administration due to poor systemic predictability; published veterinary pharmacokinetic data for swallowed lidocaine in dogs and cats is limited. The terminal blister package is PVC/PVDC aluminum stored at 25°C/60% RH to prevent moisture pickup and erosion of tablet integrity.
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Liduo Powder Veterinary Grade API is manufactured as a multi-route active substance for direct incorporation into tablets, injections, capsules, powders, granules, premixes, and solutions. Release occurs under a veterinary active-substance control framework aligned with 21 CFR 210/211 current good manufacturing practice and Regulation (EU) 2019/6; residual solvent control follows VICH GL18/ICH Q3C. Three physical models are supplied: a micronized powder for injectable suspension development and oral solutions, a granulated direct-compression powder for tablet and capsule manufacture, and a premix-grade powder with controlled bulk density for feed incorporation. Particle size is measured by laser diffraction according to Ph. Eur. 2.9.31, and the grade designation is assigned by D10/D50/D90 targets rather than by chemical identity. Batch release includes loss on drying by Ph. Eur. 2.2.32, residue on ignition by Ph. Eur. 2.4.16, and microbial enumeration by Ph. Eur. 2.6.12/2.6.13; route-specific bacterial endotoxin testing by Ph. Eur. 2.6.14 is applied to the injection-grade model. Because no single numeric acceptance window is universal across all compendial monographs, the certificate of analysis records the registered dossier limit for each destination route.
The principal difference is not chemical identity but breadth of route-specific control. A technical-grade powder or feed additive may meet simple assay and heavy metal limits yet fail the low bioburden, endotoxin, particulate, residual solvent, or polymorphic consistency requirements of injectable veterinary preparations. Liduo Powder is controlled for polymorphic form by Ph. Eur. 2.9.33 X-ray powder diffraction, for particulate matter in parenteral solutions by Ph. Eur. 2.9.19, and for sub-visible particle burden after reconstitution or dilution; these controls are typically absent from single-route oral powders. The product differs from bulk chemical powders in three measurable controls: residue on ignition, heavy metals, and residual solvents. A feed-grade powder may exhibit residue on ignition above 1.0%, whereas a pharmaceutical-grade API batch is controlled by Ph. Eur. 2.4.16 to a dossier-defined limit. Technical-grade material may contain solvent residues that are not controlled to the class limits of VICH GL18; such residues are unacceptable in injectable or intramammary preparations. Single-route oral powders are not typically tested for bacterial endotoxins by Ph. Eur. 2.6.14, because non-sterile oral routes do not require the same pyrogen control. Conversely, an injection-grade API alone may not exhibit the bulk density and flow properties needed for direct compression; this product provides separate physical grades to avoid forcing a single powder into inappropriate process trains.
The specification framework is organized as an analytical control grid rather than a single fixed value list. The table below identifies the principal methods and their route-specific relevance; acceptance windows are defined in the registered dossier and are batch-specific because different dosage forms impose different limits for moisture, microbial burden, and particle size.
| Control objective | Method / standard | Route relevance |
|---|---|---|
| Particle size distribution | Ph. Eur. 2.9.31 | Tablets, capsules, oral powders, premix homogeneity |
| Polymorphic form | Ph. Eur. 2.9.33 | Injectable solutions, dissolution consistency |
| Residual solvents | VICH GL18/ICH Q3C | All dosage forms |
| Heavy metals / elemental impurities | Ph. Eur. 2.4.8 | All dosage forms |
| Microbial enumeration | Ph. Eur. 2.6.12/2.6.13 | Non-sterile routes |
| Bacterial endotoxins | Ph. Eur. 2.6.14/USP <85> | Injections |
| Particulate matter | Ph. Eur. 2.9.19/USP <788> | Injections |
| Uniformity of dosage units | Ph. Eur. 2.9.40/USP <905> | Tablets, capsules, powders, granules |
The three physical models are not interchangeable in production records. The micronized model is selected when suspension particle size and injectable syringeability are critical; the granulated model is selected for direct compression and low-dust capsule filling; the premix-grade model is selected for feed mill operations where bulk density and carrier adhesion determine mix uniformity. Each model is identified by a grade-specific certificate of analysis and a stability protocol. Published data for the specific powder in all intended species is limited; model selection should therefore be verified by formulation trials under the actual equipment train.
On production-scale rotary tablet presses, the granulated model is introduced after blending in a bin blender or twin-shell blender; blend uniformity is monitored by stratified sampling according to Ph. Eur. 2.9.40 or USP <905>. The powder’s flow function is characterized by Hausner ratio and Carr’s index derived from bulk and tapped density measured by Ph. Eur. 2.9.34. A Hausner ratio below 1.25 generally indicates acceptable flow for direct compression; values above that threshold may require force-feeder optimization or wet granulation in high-shear mixers. Tablet friability is tested according to Ph. Eur. 2.9.7, and disintegration according to Ph. Eur. 2.9.1; dissolution or drug-release testing follows the registered monograph and may use Ph. Eur. 2.9.3 apparatus. Wet granulation of the micronized grade is performed in high-shear granulators with impeller and chopper speeds adjusted to avoid overgranulation, which can shift the particle size distribution and reduce dissolution rate. Typical high-shear wet granulation is performed at impeller tip speeds in the range 5–10 m/s; endpoint is not controlled by time alone but by impeller power consumption or torque. Drying in fluid-bed dryers with inlet air temperature controlled below the API thermal degradation threshold prevents polymorphic conversion; X-ray powder diffraction by Ph. Eur. 2.9.33 is used to confirm retained form. Batch-to-batch variation in the D90 fraction has been observed on production lines to influence blend segregation in direct compression; therefore the granulated grade is recommended when the tablet formulation contains high proportions of cohesive fillers.
The main processing conflict at pilot and production scale is the trade-off between particle size reduction for dissolution and overmicronization for flow. Overmicronization increases electrostatic charge, lowers bulk density, and can cause rat-holing in bin blenders; it also raises dust exposure during charging and sampling. In-line near-infrared monitoring may be used to track blend homogeneity, but calibrations must be rebuilt if the supplier changes the granulation process. The tapped density window for the granulated grade is therefore a release parameter, and the supplier reports the Hausner ratio and Carr’s index for each batch. If the Hausner ratio exceeds 1.35, direct compression may require reduced press speed or forced feeders with higher paddle frequency. Tablet hardness and disintegration are then balanced against friability; increasing compression force reduces friability but can extend disintegration beyond the limit defined in Ph. Eur. 2.9.1 or USP <701>.
Capsule filling and dry powder blending use the granulated model metered into dosator or tamping-pin capsule machines; the powder bed depth and vibratory settings are set from Carr’s index and particle size distribution. Capsule fill weight uniformity is assessed by Ph. Eur. 2.9.5; content uniformity by Ph. Eur. 2.9.40. Oral powders and granules are produced by geometric dilution in double-cone or ribbon blenders; homogeneity is confirmed by stratified thief sampling. Premix production uses the premix-grade powder to maintain carrier adhesion and reduce segregation during screw conveying and bagging; mix uniformity in medicated feed is evaluated according to applicable regional guidance, including VICH GL18 for residual solvent carryover and Ph. Eur. 2.9.12 for sieve retention where particle size is critical. For oral or topical solutions, the micronized powder is dissolved or suspended in aqueous or non-aqueous media; pH, ionic strength, and buffer capacity are adjusted after solubility screening under the applicable veterinary monograph and Ph. Eur. 2.9.20 for clarity of solutions. Published data for this specific powder in some buffer systems is limited; compatibility screening under refrigerated and accelerated storage is required before assigning a shelf life.
Selection between terminal moist-heat sterilization and aseptic filtration depends on the thermal degradation profile of the API in the final vehicle. If the degradation products exceed the qualification threshold defined in VICH GL18 or ICH Q3B under a typical 121 °C for 15 min cycle, terminal sterilization is not feasible. In that case, the solution is filtered through a validated 0.22 µm membrane and filled under Grade A laminar airflow within a Grade B background, as described in EU GMP Annex 1. The injection-grade model of Liduo Powder is therefore controlled for bacterial endotoxins by Ph. Eur. 2.6.14 or USP <85>, because endotoxin load cannot be removed by sterile filtration. Particulate contamination in the reconstituted or final solution is assessed by Ph. Eur. 2.9.19 or USP <788>; sub-visible particle counts must meet the harmonized limits for parenteral preparations. Buffering species and tonicity agents are selected for compatibility with the API and the primary packaging; glass vials, rubber stoppers, and plastic ampoules are screened for leachables and extractables according to Ph. Eur. 3.2.9 and 3.2.2 where relevant. For the injection-grade model, the manufacturing process includes an additional delumping and sieving step through a 0.5 mm or 0.2 mm screen depending on final particle size target. The resulting powder is packed in low-endotoxin double polyethylene bags inside a fiber drum; the manufacturer’s dossier states that no animal-derived materials are used in the manufacturing stream. Stability storage is conducted at 25 °C/60% RH and 40 °C/75% RH according to ICH Q1A(R2) and VICH GL3; retest periods are assigned from the resulting data. Pharmacokinetic release from the injection product should be confirmed by the applicable veterinary bioequivalence or target animal safety protocols; published data for this specific formulation is limited.
Formulation into tablets, capsules, powders, granules, premixes, and solutions is not open-ended. The powder is incompatible with strong oxidizing agents; combinations with reducing sugars in aqueous granulation may lead to Maillard-type degradation if the API contains a primary amine. The use of amine-based excipients or high-carbonate buffers can shift pH and reduce solution stability; therefore buffered systems are specified by the registered formulation rather than by general compatibility statements. Packaging selection is governed by moisture uptake, photostability, and oxygen transmission; PVC/aluminum/EVOH blisters or high-density polyethylene containers with desiccant are evaluated by stability protocols according to ICH Q1A(R2) and VICH GL3. The micronized grade is hygroscopic at relative humidity above 60%; handling and sampling are therefore performed under controlled relative humidity, with moisture content checked by Ph. Eur. 2.2.32 before compression. When the premix-grade powder is incorporated into mineral carriers or pelleted feeds, segregation can occur if the bulk density difference between API and carrier exceeds the manufacturer’s specified window; homogeneity should be confirmed by marker analysis or assay. These boundaries define the operational space within which the multi-route claim applies; outside that space, route-specific revalidation is required.
