| HS Code | 625032 |
| Product Name | Tongchang Powder Veterinary Grade API |
| Product Type | Active Pharmaceutical Ingredient |
| Grade | Veterinary Grade |
| Physical Form | Dry, free-flowing powder |
| Appearance | White to off-white powder |
| Solubility | Soluble in appropriate solvents or aqueous systems as defined by formulation |
| Particle Size Distribution | Controlled to support uniform blending and content uniformity |
| Bulk Density | Controlled for powder flow and tableting performance |
| Moisture Content | Meets established pharmacopoeial limit for veterinary powder APIs |
| Loss On Drying | Complies with the specified API quality standard |
| Assay Purity | Meets the labelled specification, typically 98.0%–101.0% on a dried basis |
| Related Substances | Impurity profile complies with relevant veterinary monograph limits |
| Residual Solvents | Complies with VICH/ICH safety limits |
| Heavy Metal Content | Within acceptable limits for veterinary API use |
| Microbial Limits | Meets acceptance criteria for non-sterile veterinary active ingredients |
| Storage Conditions | Keep tightly sealed in a cool, dry, well-ventilated area, protected from light |
| Shelf Life | Stable under recommended storage conditions for the stated shelf-life period |
| Manufacturing Quality | Produced under current Good Manufacturing Practice |
| Regulatory Compliance | Suitable for veterinary pharmaceutical manufacturing |
| Intended Application | For use in the manufacture of veterinary tablets, injections, capsules, powders, granules, premixes, and solutions |
As an accredited Tongchang 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 | Tongchang Powder veterinary grade API is packaged in 25 kg fiber drums with double polyethylene liners, sealed and labeled. |
| Container Loading (20′ FCL) | 20′ FCL container loaded with Tongchang Powder veterinary-grade API, suitable for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Shipment uses sealed, moisture-proof, child-resistant containers to prevent leakage and contamination. We comply with international hazardous material regulations, providing full documentation and Safety Data Sheets. Transport by air, sea, or ground with temperature control and tracking, ensuring safe, compliant delivery worldwide for veterinary pharmaceutical manufacturing. |
| Storage | Store Tongchang Powder Veterinary Grade API in a tightly sealed, original container, protected from light, moisture, and heat. Keep in a cool, dry, well-ventilated area below 25°C. Avoid contact with oxidizing agents or acids. Ensure container is clearly labeled and secured, inaccessible to children and non-target animals. Use within manufacturer-specified shelf life. |
| Shelf Life | Shelf life: 24 months from manufacture, stored sealed, dry, and protected from light, in original containers. |
In swine and poultry medicated feed premix manufacture, Tongchang Powder Veterinary Grade API is first assay-corrected against the bulk certificate of analysis, and the mass added to a batch is calculated by dividing the label claim of active substance per metric tonne by the bulk potency expressed on the anhydrous, solvent-free basis. The operation falls under Regulation (EC) No 183/2005 and Commission Delegated Regulation EU 2019/4; in the United States, current good manufacturing practice obligations for such feed mills are described in 21 CFR 225.30 for equipment and 21 CFR 225.40 for laboratory controls. A reference sampling plan such as ISO 6497:2002 is used to verify homogeneity, and a coefficient of variation ≤5.0% at 10 sampling points is a common in-process acceptance threshold. The addition ratio is not a single value: the API is normally formulated into an intermediate premix at 1.0–20.0% w/w active, and the final inclusion in compound feed most often falls between 0.5 and 5.0 kg of premix per metric tonne, depending on species, body weight, and withdrawal period. During production, the API is deagglomerated through a 0.8–1.2 mm stainless steel sieve and then incorporated by geometric dilution into a corncob, calcium carbonate, or lactose carrier in a double-ribbon or double-shaft paddle mixer. Mixer fill is maintained at 50–70% of rated capacity to avoid dead-zone carryover, and the qualified mixing time is established by tracer trials because published data for this specific API-carrier configuration is limited and cannot substitute for installation-specific mixer qualification. The terminal product is a free-flowing medicated premix that is subsequently mixed into pelleted or meal compound feed, not a ready-to-administer dosage form.
Drinking water administration in poultry houses requires the formulator to treat Tongchang Powder Veterinary Grade API as a water-dispersible or soluble powder rather than a feed premix. The main compliance anchors are ICH Q3C residual solvent limits, ICH Q3D elemental impurity permitted daily exposure values, and Ph. Eur. 2.9.40 uniformity of dosage units where the powder is sold in unit-dose sachets. Addition ratio is driven by the target mg of active substance per litre of drinking water: if the intended medication rate is 0.5–1.0 g powder per 1,000 mL, the dry blend is typically designed at 10–25% w/w active with dextrose monohydrate or lactose as carrier, allowing a single 1.0 kg pack to treat approximately 1,000–2,000 L of finished drinking water. The carrier is pre-dried to a moisture specification of ≤0.5% and the API is passed through a 0.5 mm screen before low-shear blending in a twin-shell or double-cone blender at 40–60% vessel fill; the blend is then packed in moisture-barrier foil laminate pouches under controlled relative humidity ≤30%. The downstream production process does not require granulation, but it does require segregation monitoring because high-speed pouch filling can stratify a blend when the API bulk density is below 0.4 g/cm³. The terminal finished product is a water-soluble oral powder that reconstitutes into medicated drinking water for broilers, layers, or turkeys.
In sterile injectable processing, Tongchang Powder Veterinary Grade API is handled under 21 CFR 210/211 and EU GMP Annex 1; a parenteral batch cannot be released without passing USP <1>, USP <85>, and USP <788> tests, and Ph. Eur. 2.6.14 is used for bacterial endotoxin quantification. The active concentration in the finished injection is set by the approved species-specific dosage, and common veterinary injectable presentations fall between 5 and 150 mg/mL; if the API has limited solubility, the dissolution step is carried out in Water for Injections at 20–25°C with pH adjustment using dilute hydrochloric acid or sodium hydroxide before the solution is made to final volume. For heat-stable molecules, the filled vials are terminally sterilized in a steam autoclave at 121°C for 15 minutes; when stability data show more than 2.0% assay loss under terminal sterilization, the batch is instead sterile-filtered through a 0.22 µm PVDF membrane and filled aseptically. The filling line uses nitrogen overlay to reduce headspace oxygen and pre-injection headspace dehydration by depyrogenated vials; rubber stoppers are bromobutyl and vials are borosilicate glass. The terminal finished product is a clear injectable solution in single-dose or multi-dose vials for cattle or swine.
When direct compression of companion animal tablets is selected, the Tongchang Powder Veterinary Grade API must sit inside a narrow particle-size and flow window; outside that window, roller compaction or wet granulation is introduced to prevent segregation and flow failure on the press. Release testing follows USP <905> uniformity of dosage units, USP <1216> tablet friability, and USP <701> disintegration; the same uniform-blend logic is cross-checked against Ph. Eur. 2.9.40. For low-dose tablets containing 0.5–10 mg active per unit, the API addition ratio is usually 0.5–5.0% w/w of the core, with microcrystalline cellulose and lactose monohydrate as direct-compression diluents; for high-dose tablets containing 50–200 mg active per unit, the active fraction can rise to 40–65% w/w, which makes the choice of dry binder and disintegrant critical because the API dominates the compact and may impair tensile strength. The process begins with screening the API through a 0.5 mm sieve, blending the diluent and disintegrant in a bin blender at 50–60% capacity, and lubricating with magnesium stearate at 0.5–1.5% w/w before compression on a rotary tablet press equipped with a force feeder. Hardness is maintained at 40–80 N for a 7–12 mm round concave punch set, and friability is held at ≤1.0%. The terminal finished product is a chewable or non-chewable tablet for dogs or cats.
At fill weights below 90 mg, the weight control limits of a direct compression line become difficult to hold, so hard capsule filling with a dosator or tamping pin machine is selected for companion animal products. The capsule fill is designed to satisfy USP <905> uniformity of dosage units and USP <701> disintegration, with dissolution testing by USP <711> where the species-specific approval requires it. The API addition ratio in a size 3 or size 4 hard capsule is most often between 0.1 and 50% w/w: a highly potent molecule may require only 0.1–5.0% w/w with lactose monohydrate and pregelatinized starch as diluents, while a high-dose molecule may occupy 20–50% w/w of the fill, making fill weight and bulk density the primary control variables. The powder API is passed through a 0.5 mm conical screen, geometrically diluted with half the diluent, blended in a V-blender at 50–60% capacity, and finally lubricated with 0.5–1.5% w/w magnesium stearate before capsule filling; inline fill weight checks are performed every 15–30 minutes and speed is reduced if the bulk density of the blend falls below 0.4 g/cm³. The terminal finished product is a hard gelatin or HPMC capsule for companion animals.
Where oral granules are preferred over tablets or capsules for large animals, Tongchang Powder Veterinary Grade API is converted into a free-flowing granulate that can be top-dressed on feed or administered by oral syringe without generating airborne dust. The granulation process is controlled under VICH GL11 stability testing and ICH Q3D elemental impurity limits, and the particle-size distribution is monitored by pharmacopoeial sieving methods; the retained granule fraction after drying is typically specified as a D50 of 200–800 µm. A practical addition ratio for oral granules is 5–20% w/w active in the final granulate, with the remainder composed of lactose monohydrate, pregelatinized starch, and an aqueous binder such as povidone or hydroxypropyl methylcellulose. The process begins by blending the API with the diluents in a high-shear granulator, adding the binder solution at a defined spray rate, wet-massing until the end-point torque is reached, wet-milling through a 1.0–2.0 mm screen, drying in a fluid-bed dryer to a moisture specification of ≤2.0%, and finally dry-sieving to remove oversized lumps. Compared with direct powder blends, the granule dosage form reduces segregation of low-dose actives during multi-dose tub handling. The terminal finished product is an oral granulate packed in single-dose sachets or multi-dose tubs for horses, swine, or other large animals.
Neonatal swine oral solutions require Tongchang Powder Veterinary Grade API to be dissolved in a vehicle based on purified water, sorbitol or glycerin, and a buffer system selected to hold the active molecule within its stability-optimized pH range. The addition ratio is expressed as mg active per mL rather than as a weight fraction of dry powder; common veterinary oral solution concentrations are 1–20 mg/mL, but the upper bound must be validated against the equilibrium solubility of the specific API in the vehicle at 20–25°C. The manufacturing line follows 21 CFR 210/211 for non-sterile finished pharmaceuticals, uses purified water meeting USP <1231> quality attributes, and releases under ICH Q3C residual solvent limits and ICH Q3D elemental impurity controls. During scale-up, pH adjustment is performed with dilute hydrochloric acid or sodium hydroxide, and the solution is filtered through a 10 µm clarifying filter before filling into amber HDPE bottles. In-process checks include pH, density, active assay, and Brix; if viscosity is above 20 mPa·s at 25°C, the filling speed is reduced to avoid foam generation and nozzle dripping. The terminal finished product is an oral solution administered by dosing syringe or automatic dosing pump to piglets, calves, or lambs.
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The Tongchang Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a multi-route active pharmaceutical ingredient presentation intended for distribution across dissimilar veterinary dosage-form manufacturing lines. The model designation is carried in the manufacturer’s registration dossier as the full dosage-form range; it is not a separate pharmacopoeial monograph code. Specifications are therefore structured as a matrix rather than a single powder grade, because the acceptance limits that secure tablet content uniformity are not identical to those that secure injectable clarity or premix homogeneity. Powder entering a tableting suite may be controlled for particle size distribution, bulk/tapped density, and flow function, while the same API destined for injectable solution must additionally meet endotoxin, bioburden, and subvisible particulate requirements according to USP <85>, Ph. Eur. 2.6.14, USP <788>, and Ph. Eur. 2.9.19. Published data for this specific configuration are limited; the following sections therefore describe the standard technical envelope defined by pharmacopoeial and VICH documents that applies to the dosage-form range.
Particle size distribution is measured by laser diffraction according to USP <429> or Ph. Eur. 2.9.31, with dry dispersion pressures typically 0.5–3.0 bar. For tablet and capsule operations, a Dv90 above 250 µm tends to increase the probability of content uniformity failure on high-speed rotary presses, while Dv10 below 10 µm increases dusting, cohesion, and flow variability through the feed frame. A mid-range Dv50 of 75–150 µm is generally suitable for direct compression and encapsulation, but the target is not universal; high-shear wet granulation may accept larger crystals if the granulation step reduces particle size or embeds the API into a densified matrix. For injectable solutions, particle size of the dry API is subordinate to solubility, clarity after membrane filtration, and subvisible particulate count in the finished solution. The powder specification therefore carries a conditional particle size envelope: oral solids require tight distribution, parenterals require low insoluble particle burden, and premix applications require resistance to segregation. Laser diffraction method transfer for this multi-route grade requires refractive index, absorption index, and dispersion energy to be fixed in the certificate of analysis; the CoA should state Dv10, Dv50, and Dv90, not mean particle size alone.
In tablet and capsule manufacturing, the powder’s bulk and tapped density determine whether the material can be filled within the punch die or capsule body before compaction or plug formation. Bulk density is measured by USP <616> or Ph. Eur. 2.9.34, and powder flow by USP <1174> or Ph. Eur. 2.9.36. A compressibility index below 20% and a Hausner ratio below 1.25 are typical release targets for direct compression, but these are not absolute limits for this API because granulated or densified versions may be released under separate specifications. The flow function coefficient measured with a ring shear tester at 3 kPa pre-shear normal stress provides a more direct indication of hopper discharge behavior than angle of repose. In capsule filling, low bulk density can cause short fill weights at high machine speeds, requiring tamping pin adjustments or forced feeding. The following matrix summarizes the dominant attribute for each finished dosage form in the product designation.
| Dosage form | Dominant API attribute | Reference method |
|---|---|---|
| Tablets | Particle size, flow, compaction | USP <429>, Ph. Eur. 2.9.31, USP <1174>, Ph. Eur. 2.9.36 |
| Injections | Endotoxin, bioburden, subvisible particulate | USP <85>, Ph. Eur. 2.6.14, USP <788>, Ph. Eur. 2.9.19 |
| Capsules | Bulk/tapped density, flow through orifice | USP <616>, Ph. Eur. 2.9.34, USP <1174> |
| Powders/granules | Loss on drying, sieve distribution, flow | USP <731>, Ph. Eur. 2.2.32, USP <786>, Ph. Eur. 2.9.12 |
| Premix | Segregation resistance, feed carrier compatibility, blend uniformity | ISO 6497, Ph. Eur. 2.9.12, NIR blend uniformity |
| Solutions | Clarity, related substances, pH, solubility | USP <621>, Ph. Eur. 2.2.29, Ph. Eur. 2.2.1 |
Non-sterile oral powders require microbial enumeration testing by USP <61>/Ph. Eur. 2.6.12 and specified absence of bile-tolerant gram-negative bacteria by USP <62>/Ph. Eur. 2.6.13. For non-sterile products, Ph. Eur. 5.1.4 Category 2 limits—total aerobic microbial count ≤ 103 CFU/g and total yeast and mould count ≤ 102 CFU/g—are common release controls, though the finished veterinary formulation may demand stricter in-house limits. Injectable use changes the requirement to bacterial endotoxins by USP <85>/Ph. Eur. 2.6.14. The endotoxin limit is derived from the maximum bolus dose per kilogram body weight; therefore a fixed powder limit is not technically defensible, and batch release must be tied to the intended parenteral product. A typical endotoxin control point for a high-volume injectable may be ≤ 0.5 EU/mg, but the final limit is calculated from K of 5 EU/kg for parenteral products divided by the maximum dose. Residual solvent testing by USP <467> or Ph. Eur. 2.4.24 should follow VICH GL18 or ICH Q3C; class 1 solvents are not used, and class 2 solvents are controlled at monograph-defined concentrations. Elemental impurities by USP <232>/USP <233> or Ph. Eur. 2.4.20 follow VICH GL28 route-specific permitted daily exposure, not a single heavy metal limit.
Because this API is also designated for injections, the multi-grade powder must be evaluated under aseptic or terminal sterilization logic that oral-only APIs do not require. If the active moiety is thermolabile, terminal steam sterilization at 121°C for 15 minutes is not possible; dry heat or gamma irradiation may be required for the API, with sterility assurance level ≤ 10-6 per USP <71> or Ph. Eur. 2.6.1. The powder for injectable solution is not necessarily supplied sterile unless designated as such; instead, it must support sterile filtration of the compounded solution through a 0.22 µm membrane without rapid clogging or extractables increase. Filter validation follows PDA Technical Report 26 and requires bacterial retention, chemical compatibility, and extractables data. Solution clarity is assessed after dissolution by Ph. Eur. 2.2.1, and subvisible particulate matter by USP <788> for large-volume parenterals or USP <789> for small-volume parenterals. The most common process conflict is that a particle size distribution optimized for direct compression may contain fines that pass through the filter but contribute to higher bioburden loading; the injectable route therefore requires a cleaner, more endotoxin-controlled powder than the same tableting grade.
| Parameter | Method | Typical limit |
|---|---|---|
| Assay on dried basis | USP <621>, Ph. Eur. 2.2.29 | 98.0–102.0% |
| Loss on drying | USP <731>, Ph. Eur. 2.2.32 | ≤ 1.0% |
| Water content | USP <921>, Ph. Eur. 2.5.12 | ≤ 2.0% or method-specific |
| Bacterial endotoxins, injectable route | USP <85>, Ph. Eur. 2.6.14 | ≤ 0.5 EU/mg illustrative |
| Microbial enumeration, non-sterile oral route | USP <61>, Ph. Eur. 2.6.12 | ≤ 103 CFU/g TAMC |
| Subvisible particulate, after solution | USP <788>, Ph. Eur. 2.9.19 | Meets large-volume parenteral limits |
| Residual solvents | USP <467>, Ph. Eur. 2.4.24 | Class 2 limits from VICH GL18 |
| Elemental impurities | USP <232>/233, Ph. Eur. 2.4.20 | Route-specific PDE from VICH GL28 |
| Particle size Dv90, oral solids | USP <429>, Ph. Eur. 2.9.31 | ≤ 250 µm |
Premix and granule applications replace small unit-dose content uniformity constraints with segregation control, feed carrier adhesion, and blend homogeneity. A powder with wide particle size distribution may be acceptable for tablets but will segregate during vibratory transfer into feed bags or silos. For premix, the API is commonly dry-dispersed onto a carrier such as lactose, wheat middlings, or calcium carbonate; the resulting concentration is often in the range of 10–100 g/kg, but exact loadings are driven by the veterinary dosing table and the target species. Blend uniformity samples drawn according to ISO 6497 should show assay coefficient of variation ≤ 5.0% across the batch. Granulation reduces segregation by forming API-loaded agglomerates, but wet granulation requires binder addition to be adjusted for particle surface area; fine API fractions may require binder solution volumes 15–25% higher than coarse fractions in high-shear mixers. Loss on drying by USP <731> or Ph. Eur. 2.2.32 is released at ≤ 1.0% for powders intended for moisture-sensitive formulations, but granules may require lower values to prevent mold growth in feed premixes.
The assay and organic impurity profile are determined by high-performance liquid chromatography using USP <621> or Ph. Eur. 2.2.29. Method validation follows VICH GL2 and ICH Q2(R1): specificity against forced-degradation impurities, linearity, accuracy, precision, range, and quantitation limit. For many veterinary APIs, release assay is controlled at 98.0–102.0% on the dried basis; individual unspecified impurities are typically capped at 0.10% and total impurities at 1.0%, but these thresholds must be aligned with the active moiety monograph and the maximum daily dose. Degradation products above the identification threshold under VICH GL11 or ICH Q3B require identification and toxicological qualification. Stability studies under VICH GL3 or ICH Q1A(R2) include long-term, intermediate, and accelerated storage; the powder may be bracketed across the dosage-form options if the packaging configuration is shown to be equivalent. Mass balance is not used as a sole acceptance criterion because HPLC response factors for impurities differ from the parent API. Water content by USP <921>/Ph. Eur. 2.5.12 is reported separately from loss on drying, especially for injectable solutions where the hydration state may affect assay on the as-is basis.
Process validation on a commercial line must cover the powder’s behavior when transferred across the seven dosage forms. A tableting run on a rotary press with 16-station tooling may require compression force from 8 kN to 22 kN, while capsule filling on an intermittent or continuous motion machine introduces different dwell times. These differences are not resolved by a single particle size specification; they require formulation-specific qualification batches with critical quality attributes such as hardness, friability, disintegration, and dissolution. For injectable compounding, the solution is prepared in a jacketed vessel with high-torque agitation; dissolution under defined temperature and pH must be monitored because undissolved API can block the sterilizing filter and destabilize the batch. Equipment experience from commercial lines indicates that switching from oral-grade powder to injectable-grade powder without reducing bioburden can lead to filter throughput collapse and batch rejection. Published data for this specific configuration are limited, so process qualification remains the controlling evidence.
Compared with an oral-only veterinary API, this product is distinguished by the requirement to maintain injectable-grade bacterial endotoxin and particulate control while also providing powder flow suitable for tableting and encapsulation. A technical-grade feed API may have a broader related-substance envelope and no GMP documentation for parenteral use, whereas the Tongchang multi-dosage grade is expected to be manufactured under ICH Q7 or EU GMP Part II with full audit trail. Differences from human-grade APIs include veterinary-specific documentation under Regulation (EU) 2019/6 or VICH GL1 through GL28; the active moiety and impurity limits are not automatically identical to human pharmacopoeial monographs. The tablet/injection/capsule/powder/granule/premix/solution designations are therefore not merely packaging labels. They signal that the powder has been assessed against a combined specification matrix, and each batch record must declare which dosage-form sub-specification has been released. If the powder is shipped under a single certificate of analysis, the CoA should state the test results for the most stringent intended use, typically injectable, while additional oral-solid parameters are reported separately.
