| HS Code | 611936 |
| Property 1 Product Name | Tongru Powder Veterinary Grade API |
| Property 2 Product Type | Veterinary Active Pharmaceutical Ingredient |
| Property 3 Grade | Veterinary Grade |
| Property 4 Physical Form | Fine dry powder |
| Property 5 Intended Use | Used as an active ingredient in veterinary pharmaceutical manufacturing |
| Property 6 Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Property 7 Appearance | Powder with uniform particle characteristics suitable for formulation |
| Property 8 Solubility | Solubility profile should meet formulation requirements for the selected veterinary dosage form |
| Property 9 Stability | Stable when stored under recommended conditions |
| Property 10 Storage Conditions | Store in a tightly closed container in a cool, dry, well-ventilated area |
| Property 11 Shelf Life | Typically up to 24 months under proper storage |
| Property 12 Packaging | Sealed pharmaceutical-grade packaging such as double-lined bags or drums |
As an accredited Tongru 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 | Tongru Powder veterinary-grade API is packaged in 25 kg drums with double polyethylene liners for safe, stable storage. |
| Container Loading (20′ FCL) | Tongru Powder Veterinary Grade API is packed securely in sealed containers and loaded into a 20-foot FCL for safe transport. |
| Shipping | Tongru Powder Veterinary Grade API ships as a sealed, moisture-protected powder in sterile, tamper-evident containers. Transport in dry, ventilated, temperature-controlled conditions, away from sunlight and incompatible substances. Ensure compliance with veterinary pharmaceutical shipping regulations. Handle with protective equipment to prevent dust exposure and contamination during transit. |
| Storage | Store Tongru Powder veterinary grade API in a tightly sealed container, protected from light, moisture, and heat. Keep in a cool, dry, well-ventilated area below 25°C. Avoid direct sunlight and contact with incompatible substances. Ensure container is properly labeled and kept out of reach of children and animals. Use within shelf life once opened. |
| Shelf Life | Shelf Life: 24 months from manufacture date when stored unopened in sealed containers in a cool, dry place. |
For companion-animal oral tablets, Tongru Powder Veterinary Grade API is pre-formulated by determining whether lot-to-lot particle-size distribution supports direct compression or forces a wet-granulation detour. The API is incorporated at 5%–40% w/w of the core tablet mass for unit strengths above 1 mg; low-dose strengths are not added directly but are first pre-blended at a 1:10 ratio with milled lactose monohydrate, then diluted stepwise to 0.5%–2.0% w/w active in the final blend. Each lot is weighed on a dried basis using the supplier’s assay value; an assay of 98.5% w/w yields a correction factor of 1.015. Blend uniformity acceptance follows USP <905> Uniformity of Dosage Units, and tablet disintegration follows USP <701> Disintegration; in-process sampling is conducted under 21 CFR 211.110. Compression is performed on a rotary tablet press with 10 mm round flat-faced bevelled tooling, a pre-compression force of 2–4 kN, and a main compression force of 8–25 kN. Tablet hardness is held between 60 N and 100 N, and final blend loss on drying is controlled at 1.5%–3.0% w/w; deviations above 3.0% produce punch filming and edge chipping during campaigns exceeding 300,000 tablets. Terminal dosage forms are 25 mg, 50 mg, 100 mg, and 200 mg scored tablets, as well as chewable tablets for dogs and cats.
Injectable manufacturing with the same API begins with solubility mapping in Water for Injection across a pH range of 2.0 to 8.0, because the salt form and pH determine whether the solution can be sterile-filtered before terminal autoclaving. The active ingredient is typically formulated at 2%–20% w/v; for high-dose parenterals, the limiting factor is not active concentration alone but solubility at a physiologically acceptable pH and the volume per injection site. Terminal sterilization is evaluated against USP <71> Sterility, USP <85> Bacterial Endotoxins, and USP <788> Particulate Matter in Injections. The bulk solution is prepared in a 316L stainless-steel mixing vessel with a bottom-mounted magnetic-drive agitator, sparged with nitrogen when forced-degradation studies identify oxygen sensitivity, pH-adjusted with 0.1 M hydrochloric acid or sodium hydroxide, and passed through a 0.22 µm PVDF filter before filling into depyrogenated USP Type I glass vials. Autoclave cycles of 121°C for 15 min, corresponding to an F₀ ≥ 8 min, are used only where pH drift during sterilization remains ≤ 0.3 units and assay loss remains ≤ 2%; when this window cannot be met, the product is converted to a pre-sterilized aseptic filtration line. Finished presentations are 100 mL, 250 mL, and 500 mL single-dose or multi-dose vials with closure integrity verified by dye ingress or vacuum decay.
Medicated premix lines handling this veterinary-grade API for swine and broiler feed operations are designed around the segregation potential between the micronized active and coarse carriers. The API is diluted through a geometric sequence from an initial 10% w/w pre-blend to 1% w/w, 2.5% w/w, 5% w/w, or 10% w/w intermediate premixes using pre-screened rice hull or corn cob meal; final feed inclusion rates are calculated from the target species dose and are commonly expressed in grams of active ingredient per metric ton (g/t), with working ranges of 50–500 g/t. Compliance is anchored to FDA 21 CFR Part 225 and Part 226 for medicated feed manufacturing, EU Regulation 183/2005 on feed hygiene, and ISO 6497:2002 for feed sampling. Mixing is carried out in a horizontal ribbon mixer with a batch capacity of 2,000 kg and a paddle speed of 25–30 rpm; mixing time is validated for 8–12 min, with blend uniformity acceptance of coefficient of variation ≤ 5%. Production-scale failure modes include electrostatic adhesion to mixer walls at RH < 30%, dead-spot accumulation behind paddle tips, and discharge segregation when carrier-bulk-density differences exceed 0.3 g/cm³. Finished goods are 1%, 2.5%, 5%, and 10% w/w medicated premix bags, with top-dress formulations for feed mill integration.
| Stage | Mass ratio | Equipment | Acceptance criterion |
|---|---|---|---|
| API–carrier pre-blend | 1:10 (w/w) | planetary paddle mixer | CV ≤ 5% |
| Intermediate to final premix | 1:10 (w/w) | horizontal ribbon mixer | CV ≤ 5% |
| Premix to final feed | 2–10 kg/metric ton | horizontal paddle or continuous mixer | CV ≤ 10% and label claim |
Water-soluble oral powders for poultry and swine are manufactured in blending suites maintained at 20°C–25°C and RH ≤ 40%, because the API and water-soluble excipients form a caked mass when sorption exceeds 2.0% w/w. The active ingredient is incorporated at 10%–50% w/w with dextrose monohydrate or milled lactose monohydrate; the finished powder is dissolved in drinking water to deliver 100–400 mg active ingredient per liter for flock or herd administration. Testing follows Ph. Eur. chapter 2.9.12 for sieve analysis and USP <786> for particle size distribution, supported by stability-indicating assay methods from the product dossier. Blending uses a 1,000 L bin blender at 10 rpm for 15 min, followed by vacuum transfer to form-fill-seal packaging; loss on drying of the final powder is controlled at ≤ 2.0% w/w. The terminal packaged configurations are 100 g, 500 g, and 1 kg foil-composite sachets or HDPE jars with induction-sealed liners.
Non-sterile oral solution lines for swine and calves use a different solvent system from injectables because preservative compatibility and long-term room-temperature stability dictate pH and buffer selection. The veterinary-grade API is dissolved at 1%–10% w/v in purified water with co-solvents such as propylene glycol or glycerol at 5%–20% v/v where water solubility alone is insufficient. The solution is mixed in a 316L stainless-steel tank, adjusted to pH 3.0–5.5 with citrate or phosphate buffer, passed through a 0.45 µm clarifier filter, and filled into amber PET or HDPE bottles under a nitrogen cap blanket where oxidative degradation is observed. Antimicrobial effectiveness testing follows USP <51>, and stability-indicating assays follow ICH Q1A(R2) principles with bracketed or matrixed designs. Finished configurations are 10 mL, 20 mL, 100 mL, and 1 L oral drench or metering-pump bottles.
Neonatal calf and piglet oral granules require a narrow granule-size distribution because the product is mixed into milk replacer or oral rehydration solutions, and dissolution lag time is directly influenced by granule porosity. The API is incorporated at 5%–30% w/w in a lactose-mannitol matrix and top-spray granulated in a fluid-bed dryer with inlet air at 60°C–70°C, product temperature at 30°C–40°C, atomization pressure of 1.0–1.5 bar, and a 5% w/v povidone K30 binder solution. Granule loss on drying is held at 1.5%–2.5% w/w, and the dried granulate is screened to a target particle size of 200–710 µm; this range prevents segregation during sachet filling while allowing rapid dispersion in liquid. Compliance testing follows Ph. Eur. chapter 2.9.12 for sieve analysis and USP <786> for particle size distribution; published production-scale data for this specific API in fluid-bed granulation is limited, so process parameters must be re-established with design-of-experiments on each new API lot. Finished products are 1 g, 5 g, and 10 g unit-dose sachets and 100 g bulk granules for dosing pumps or manual top dressing.
Where capsule administration is required for equine patients or for companion-animal dose escalation, low-shear dry granulation converts the API powder into a densified granulate that improves flow into dosator-type capsule filling equipment. The active ingredient is incorporated at 20%–60% w/w of a 300–500 mg fill mass in size 0 or size 1 hard gelatin capsules; the formulation includes microcrystalline cellulose, sodium starch glycolate, and magnesium stearate at 0.25%–0.75% w/w. In-process control follows USP <711> Dissolution and USP <905> Uniformity of Dosage Units, with release testing under 21 CFR 211.165. The dry granulate is produced by roller compaction or slugging to a tap density of 0.65–0.75 g/mL; capsule fill weight uniformity requires a coefficient of variation ≤ 3% at production speeds of 20,000–40,000 capsules/h. Terminal dosage forms are 250 mg and 500 mg capsules, packaged in 60-count or 500-count HDPE bottles with child-resistant closures.
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The Tongru Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a bulk active pharmaceutical ingredient powder intended for downstream processing into multiple veterinary dosage forms. The designation covers compendial-quality material whose release is determined by active-substance monographs rather than by a single universal purity claim. The powder is supplied in dosage-form-specific grades with different particle-size distribution, bulk density, and microbial-quality annexes; no single batch is automatically suitable for every route without route-specific validation. The product is described in the request as Tongru Powder Veterinary Grade API; published model-code nomenclature is limited, and ordering typically proceeds through the certificate of analysis and the intended dosage form rather than through a proprietary commercial code. The material is supplied with documentation covering appearance, identity, assay, related substances, loss on drying, residue on ignition, residual solvents, and, where parenteral or intra-mammary use is intended, bacterial endotoxins and bioburden.
The dosage-form-specific grades can be understood as the product’s functional variants. A direct-compression-grade annex emphasizes flowability and low segregation; a micronized-grade annex emphasizes surface area and dissolution rate; a parenteral-grade annex emphasizes low endotoxin and clean reconstitution. The same active substance may be distributed under these different annexes without changing its chemical identity. The supplier’s product specification does not assign a single numerical code to all variants; instead, the intended dosage form and manufacturing route determine which annex is applied at release.
Veterinary pharmacopoeial-grade API powder is not a single purity class; it is a specification matrix that changes with route of administration, dosage form, and processing train. For oral tablets and capsules, the significant release parameters include particle size, bulk density, moisture content, and chemical purity. For injectable solutions, the same active substance must also meet bacterial endotoxin limits, sub-visible particulate controls, and reconstitution clarity criteria that would be irrelevant in a feed premix. The product is therefore issued with route-dependent specification annexes; a batch that passes oral monograph requirements does not automatically comply with parenteral monograph requirements unless the annexed tests have been performed and the results stated.
Assay, related substances, and residual solvent controls follow the corresponding active-substance monograph. Common compendial test methods include Ph. Eur. 2.2.32 or USP <731> for loss on drying, Ph. Eur. 2.2.24 for infrared absorption spectrophotometric identification, and ICH Q3C for residual solvent classification. The powder is released against a certificate of analysis in which specification limits are substance-specific. No universal numerical assay range can be assigned to every active ingredient; the acceptable range is defined by the monograph and is stated on the batch document.
One major difference from non-pharmacopoeial feed-grade material is the extension of control beyond simple chemical purity. Feed-grade powder may be sold without a formal related-substance profile or without residual solvent data. Technical-grade powder may contain process impurities that exceed pharmacopoeial thresholds because the material was not purified for pharmaceutical use. Those differences directly affect formulation robustness: an impurity present above monograph limits can alter dissolution, colour, or stability even if the label assay appears acceptable.
| Control attribute | Tongru veterinary pharmacopoeial grade | Feed-grade active powder | Technical-grade powder |
|---|---|---|---|
| Identity | IR spectrum or HPLC retention time against reference standard | Often limited to visual appearance or supplier label | Not normally tested against finished-product identity criteria |
| Related substances | HPLC area percent with total and specified impurities per monograph | Typically not controlled | May contain process-related impurities above pharmacopoeial thresholds |
| Residual solvents | ICH Q3C Option 1 or Option 2 limits | Not normally assigned | May retain process solvents |
| Bacterial endotoxins | Tested only for parenteral or intra-mammary grade annexes | Not controlled | Not controlled |
| Particle size | Specified by D10, D50, D90 or sieve fraction relevant to dosage form | Usually unstandardized | Usually unstandardized |
| Documentation | Certificate of analysis, residual solvent declaration, GMP declaration | Limited feed-safety documentation | Technical data sheet only |
The central processing conflict in multi-dosage-form API supply is particle size. A particle-size distribution optimized for direct compression may be too coarse for injectable solution compounding because dissolution rate in aqueous media is surface-area-dependent. A micronized grade optimized for solution or suspension work may be too cohesive for direct compression and may require granulation before tableting. The formulator must therefore select the grade by the intended processing route, not by a generic “veterinary-grade” label. Published data for this specific Tongru configuration is limited; pilot-scale trials with the selected grade are necessary before commercial batch sizes are ordered.
For oral solid dosage forms, the powder is processed by direct compression, wet granulation, or capsule filling. Direct compression demands a free-flowing powder with low segregation tendency; the certificate of analysis should include bulk density, tapped density, and compressibility index because these values influence die-fill reproducibility on rotary tablet presses. If the granular grade is free-flowing, the blend is compressed after lubrication with magnesium stearate or sodium stearyl fumarate. Magnesium stearate addition above 1.0% by weight may retard dissolution of poorly soluble actives because of hydrophobic film formation on the powder surface; the exact interaction is formulation-dependent.
Wet granulation is used when the powder is hygroscopic, cohesive, or of low bulk density. The material is dry-blended in a high-shear granulator, then granulated with purified water or a binder solution. Production-scale high-shear granulators with impeller speed 150–200 rpm and chopper speed 1500–3000 rpm require binding-fluid addition over 3–5 min; these are substance-specific starting points established by factorial design. The main processing failures on manufacturing lines are over-wetting, leading to coarse granules with high residual moisture, and under-granulation, leading to poor compressibility. Drying is carried out in a fluid-bed dryer or tray dryer at a product temperature below the degradation onset determined by forced-degradation studies.
Capsule filling can be performed after lubricant addition; segregation between API and excipient is minimized by matching particle sizes. When the active powder is micronized, it is pre-blended with a portion of the diluent before being passed through a 0.5 mm or 1.0 mm screen to break agglomerates. The resulting blend may be filled into hard gelatin or HPMC capsules; fill weight limits are derived from assay and content uniformity testing. For low-dose capsules, the powder is commonly triturated with lactose monohydrate or microcrystalline cellulose in a geometric dilution series, because direct weighing of sub-100 mg active quantities is not robust at production scale.
For powder, granule, and premix applications, the active substance is typically incorporated into a feed or diluent matrix in a ribbon blender, paddle mixer, or twin-shaft mixer. Homogeneity is verified by sampling at multiple points in the mixer and comparing assay results; a common acceptance limit is ±10% of label claim or a relative standard deviation not greater than 5% depending on the regulatory guideline. For low inclusion rates, the API is pre-dispersed with a carrier such as silica or lactose monohydrate before being added to the main batch. This step prevents localized concentration gradients that can occur when an active powder with a small mass fraction is mixed directly into a large-volume feed carrier.
Solutions for oral administration are prepared by dissolving the powder in purified water or a co-solvent system. If the active substance is weakly acidic or weakly basic, pH adjustment may be required to achieve complete dissolution; solubility data are generated in the final solvent at the target concentration and at 2–8 °C and 25 °C if the product is stored refrigerated. The resulting solution is filtered to remove undissolved particulates and, where required, preserved with a compendial preservative. For water-soluble powders distributed as drinking-water medications, the product is compounded with lactose or dextrose and packaged in low-moisture-permeability sachets; the main stability risk is hydrolysis, so the finished package is selected for its water vapour transmission rate rather than for light protection alone.
| Route / form | Critical added controls | Typical test reference |
|---|---|---|
| Oral tablets / capsules | Particle size distribution, bulk density, moisture, dissolution in QC media | Ph. Eur. 2.9.3; USP <711> |
| Oral solutions / powders | Solubility, clarity after reconstitution, pH | Ph. Eur. 2.2.3 |
| Injections | Endotoxin, solution clarity, sub-visible particles, bioburden | Ph. Eur. 2.6.14; USP <85> |
| Premix / granules | Bulk density, sieve fraction, content uniformity after mixing | Pharmacopoeial premix monograph |
For injectable dosage forms, the API powder is dissolved or suspended in Water for Injection, then filtered through a sterilizing-grade membrane. The filtration train normally contains a depth or membrane prefilter and a 0.22 µm sterilizing-grade membrane. If the active substance contains visible crystalline aggregates or if the solution is near saturation, the prefilter can plug; in such cases, the powder particle size, dissolution temperature, and mixing time are adjusted before filtration. Bacterial endotoxin control is critical because endotoxin is not removed by sterilizing-grade filtration and may not be inactivated by autoclaving. The endotoxin limit is calculated from the maximum dose per kilogram of body weight and is stated in the finished-product dossier; compendial testing may follow Ph. Eur. 2.6.14 or USP <85>.
Particulate matter in injectable solutions is controlled according to Ph. Eur. 2.9.19 or USP <788>, but those limits apply to the finished product, not to the raw API powder. The API contributes to the particulate burden through insoluble impurities, filter shedding, or incomplete dissolution. The powder must therefore be characterized for solution clarity and sub-visible particle behavior in the intended solvent; if an API lot passes chemical assay but produces a cloudy solution, it is unsuitable for parenteral use. This route-specific performance difference is not visible in a non-compendial technical-grade powder data sheet.
Sterility is a finished dosage form attribute. The product is not necessarily supplied as sterile powder; terminal sterilization of filled vials is commonly validated by moist heat at 121 °C for 15 min or by aseptic filtration followed by aseptic filling. If the active substance is thermolabile, the formulator uses aseptic processing; in that case, the non-sterile API must have a controlled bioburden before sterile filtration. The API certificate of analysis for injectable use should therefore include total aerobic microbial count and endotoxin testing; a powder that is sold only for oral use does not normally carry the same annex. This is a principal difference in specification depth between oral and parenteral grades.
The same active substance can have different endotoxin acceptance criteria depending on route. An oral premix may have a high allowable endotoxin load because the gastrointestinal tract acts as a barrier; an injectable solution requires a much lower limit because endotoxin introduced parenterally is pharmacologically active in the bloodstream. The limit is not derived from the API’s chemical purity but from the maximum intended dose and body weight. For this reason, the Tongru multi-dosage-form product should be ordered with the route-specific annex; a default oral-grade certificate of analysis is not sufficient for injectable formulation work.
Residual solvents are also route-sensitive. ICH Q3C classifies solvents into classes according to toxicity; the same solvent may be acceptable in an oral product at a higher limit than in a parenteral product. The certificate of analysis should list residual solvent content by headspace gas chromatography, and the formulator should compare the values against the final excipient and finished-product limits. If the API is produced with an organic solvent that is not listed in the dossier, the material is not a direct substitute for a compendial powder from a qualified source. This documentation gap is one of the main differences between a veterinary pharmacopoeial API and a non-compliant technical powder.
Manufacture of the API is expected to follow ICH Q7 Good Manufacturing Practice for active pharmaceutical ingredients, with documentation of cleaning validation, raw material identification, and change control. Feed-grade material is not necessarily produced under the same GMP standard. For veterinary marketing-authorisation dossiers, specifications and stability may be developed under VICH GL18 and VICH GL11; these standards create a different evidentiary burden than technical-grade material. The product therefore differs from general feed supplements by being positioned as a pharmaceutical intermediate, not as a final feed additive.
Batch-to-batch variance on production lines sometimes emerges as a weight-uniformity failure even when assay is within specification. On a rotary tablet press operating at 30–60 rpm, a highly cohesive milled grade can cause intermittent fill-depth variation; the operator compensates by adjusting feed-frame speed or by adding 0.25–0.5% glidant such as colloidal silicon dioxide. In capsule-filling operations, relative humidity above 45% can cause powder adhesion to tooling surfaces, especially for moisture-sensitive actives. These are production-scale observations that do not appear in a simple certificate-of-analysis review and are why pilot-scale runs are required before commercial batch release.
The powder may require protection from moisture, oxygen, or light depending on the active substance. The manufacturer’s recommended storage conditions are stated on the certificate of analysis; common storage ranges for bulk APIs are 15–25 °C in tightly closed containers protected from light. If the API is hygroscopic, the material is packaged in double polyethylene bags inside aluminium-laminated drums, and desiccant is added when the ambient relative humidity exceeds 60% during dispensing. Pre-drying before compression is performed when loss-on-drying exceeds the monograph limit; the drying process is performed in a tray dryer or low-shear tumble dryer with temperature below the degradation threshold of the active substance.
Incompatibilities are substance-specific and must be evaluated against the planned excipient system. For example, amine-containing excipients can react with active substances bearing electrophilic functional groups, leading to related-substance formation during storage. The formulator should perform binary compatibility studies at accelerated conditions, such as 40 °C / 75% relative humidity for 4 weeks, to isolate unacceptable interactions before committing to a full formulation. Tongru Powder Veterinary Grade API does not include a universal compatibility guarantee; each excipient combination must be supported by stability-indicating data.
