| HS Code | 674976 |
| Product Name | Xinyi Powder Veterinary Grade API |
| Api Substance | Xinyi Powder |
| Grade | Veterinary Grade |
| Intended Species | Cattle, pigs, poultry, sheep, goats, horses, and other livestock |
| Compatible Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Appearance | White or almost white crystalline powder |
| Solubility | Suitable for formulation into aqueous and non-aqueous vehicles; solubility profile depends on the specific API |
| Purity Assay | 98.0% to 102.0% on dry basis |
| Particle Size | D90 ≤ 100 µm for powder blending and premix uniformity |
| Loss On Drying | ≤ 1.0% |
| Residue On Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Storage Conditions | Store in tightly sealed original containers in a cool, dry, and well-ventilated area |
| Shelf Life | 36 months when unopened and stored under recommended conditions |
| Packaging | 25 kg net weight in double polyethylene-lined fiber drums or as agreed |
| Regulatory Compliance | Complies with applicable veterinary pharmacopoeia standards, including CP, USP, or EP |
As an accredited Xinyi 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 | Xinyi Powder Veterinary Grade API is packaged in sealed double-layer polyethylene bags inside aluminum foil drums, 25 kg per drum. |
| Container Loading (20′ FCL) | 20' FCL container loaded with Xinyi Powder Veterinary Grade API, safely packed in drums, ready for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | This veterinary-grade API powder is shipped in sealed, moisture-proof containers to ensure stability and purity. All transport meets international chemical safety regulations, with proper labeling and documentation. Deliveries are temperature-controlled when required, and handling instructions emphasize protection from light, heat, and humidity to maintain product integrity throughout transit. |
| Storage | Store Xinyi Powder Veterinary Grade API in a tightly sealed, original container in a cool, dry, well-ventilated area. Protect from moisture, direct sunlight, and high temperatures. Keep away from incompatible substances, food, and animal feed. Maintain room temperature below 25°C and ensure container is re-sealed immediately after each use. |
| Shelf Life | Shelf life is typically 24 months from manufacture when stored sealed, dry, and protected from light and moisture. |
Direct compression of the veterinary API powder labeled Xinyi Powder Veterinary Grade API is constrained by its particle-size distribution, not merely by assay potency. A batch suitable for direct compression should exhibit a median particle diameter D50 between 75 µm and 150 µm, a D90 no greater than 250 µm, and a Hausner ratio below 1.25; when the Hausner ratio exceeds 1.35, the formulation is shifted to a high-shear wet granulation stage using a 600 L high-shear mixer, purified water or povidone K30 binder at 0.5–2.0% w/w, and fluid-bed drying at inlet air temperature 50–65 °C until loss on drying reaches 1.5–2.5%. The API addition ratio in the finished tablet mass is set between 5.0% and 40.0% by weight for most oral tablets and ruminant boluses, with microcrystalline cellulose or lactose monohydrate making up 30–60%, crospovidone or sodium starch glycolate 2–5%, colloidal silicon dioxide 0.2–1.0%, and magnesium stearate 0.5–1.5%. Compression on a rotary tablet press operating at 15–25 kN for 5 mm–12 mm round tooling and at turret speeds of 20–60 rpm produces tablets with hardness 50–150 N and friability less than 1.0% according to Ph. Eur. 2.9.7. Weight uniformity must satisfy Ph. Eur. 2.9.40 or USP <905>, while disintegration is controlled by Ph. Eur. 2.9.1 or USP <701> with a limit of 15 min in water at 37±2 °C unless a film-coating system using hydroxypropyl methylcellulose and polyethylene glycol is applied. Finished dosage types include scored tablets, chewable tablets, and large 1 g–20 g boluses for cattle, sheep, and swine, with terminal packaging in aluminum/aluminum blister or high-density polyethylene bottles containing desiccant canisters.
For aqueous injectable formulations, the critical process boundary is the point at which the dissolved API is exposed to terminal sterilization heat, because the powder's impurity profile after reconstitution depends on the pH buffer, oxygen headspace, and hold time between dissolution and filtration. Aqueous solutions are prepared at API concentrations of 1.0% to 20.0% w/v, with sterile Water for Injection as the vehicle, sodium chloride 0.6–0.9% as tonicity modifier, phosphate or citrate buffer at pH 6.0–7.4, and sodium metabisulfite 0.1–0.3% only where oxidative degradation is demonstrated by forced degradation studies under VICH GL5. Suspensions may reach 30.0% w/v, but viscosity and syringeability must be validated on a rotational rheometer with a cone-plate geometry at 25 °C, with apparent viscosity generally maintained below 50 mPa·s at a shear rate of 100 s−1. The manufacturing line is designed as an aseptic fill-finish train; the bulk solution is filtered through a 0.22 µm PVDF membrane filter after a 0.45 µm prefiltration, and if the molecule is thermostable the solution is sterilized in a water-spray autoclave at 121 °C for 15 min, corresponding to F0 ≥ 8 min. For heat-labile APIs, filtration followed by aseptic filling is mandatory and requires environmental monitoring under EU GMP Annex 1. Sterility testing follows Ph. Eur. 2.6.1 or USP <71>; bacterial endotoxin limits are set according to Ph. Eur. 2.6.14 or USP <85>; particulate matter is controlled by Ph. Eur. 2.9.19. Terminal products include 10 mL, 50 mL, and 100 mL single-dose vials and 250 mL multi-dose vials with chlorobutyl rubber stoppers and aluminum flip-off seals.
After low-shear blending and dosator-type capsule filling, API particle-size distribution, moisture content, and glidant ratio determine whether the batch remains within acceptance limits for mass uniformity. Capsule formulations based on the veterinary API powder typically incorporate 2.0% to 60.0% by weight active ingredient, with lactose monohydrate or microcrystalline cellulose at 20–80%, croscarmellose sodium at 2–5%, colloidal silicon dioxide at 0.2–1.0%, and magnesium stearate at 0.25–1.0%; for high-potency low-dose capsules, a trituration step with a 1:10 geometric dilution is inserted before the final 600 L V-blender mixing at 25 rpm for 15 min. In-process moisture is held below 45% RH in the encapsulation suite because high moisture increases API agglomeration and punch adhesion on tamping-pin machines. Commercial encapsulators running at 30,000–90,000 capsules/h require feed shoe agitator speeds of 20–40 rpm and periodic in-process weight checks every 15–20 min against the target fill weight, with a mass uniformity acceptance value not exceeding 15 under Ph. Eur. 2.9.5 or USP <905>. Dissolution is evaluated by Ph. Eur. 2.9.3 or USP <711> using apparatus 2 at 50 rpm in 900 mL of 0.1 M hydrochloric acid for immediate-release capsules, with a Q value not lower than 75% at 45 min unless a slower release is explicitly specified in the product dossier. Terminal dosage forms include hard gelatin capsules from size 4 to 00 and hydroxypropyl methylcellulose vegetarian capsules for companion-animal use, typically in 25 mg, 50 mg, 100 mg, and 250 mg strengths, packed in PVC/PVDC/aluminum blisters or HDPE bottles containing a silica gel desiccant.
Soluble drink-water powders are formulated to suspend or dissolve an API in a defined volume of drinking water under barn-level pH and water-hardness conditions; therefore the formula is not judged by tablet hardness but by wetting time, sedimentation rate, and solution clarity after dilution at 1:1000 in water of 300–500 mg/L calcium carbonate equivalent. The API addition ratio in the dry powder is set between 1.0% and 70.0% by weight depending on the dose and target final concentration, with dextrose monohydrate or lactose as carrier at 30–90%, citric acid and sodium bicarbonate at 10–30% where an effervescent disintegration is required, povidone K30 at 0.5–2.0% as dry binder, sodium lauryl sulfate at 0.1–0.5% as wetting agent, and an antifoam agent at 0.1–0.3% when the powder is used in automatic proportioning systems. Dry blending is carried out in a 2000 L double-ribbon blender at 20–30 rpm for 20–30 min, followed by top-spray fluid-bed granulation at inlet air temperature 50–70 °C, product temperature 30–40 °C, and spray rate 150–250 g/min for a 500 kg batch, until loss on drying is less than 2.0%. The granulated material is sieved through a 500 µm sieve; material retained above 800 µm is milled through a 1.0 mm screen. Microbiological quality of the non-sterile powder must meet Ph. Eur. 5.1.4 with total aerobic microbial count below 103 CFU/g and total yeasts and molds below 102 CFU/g, and the manufacturing site should comply with 21 CFR 211 for veterinary finished pharmaceuticals and EU Regulation 2019/6. Finished dosage forms include 100 g, 500 g, and 1 kg laminated foil sachets, 5 kg HDPE pails with tamper-evident lids, and 10 kg bag-in-box configurations for poultry and swine drinking-water medication.
In commercial feed mills, a medicated premix is inserted after the main batch mixer because post-mixer addition reduces cross-contamination during high-throughput pelleting. The premix formulation based on Xinyi Powder Veterinary Grade API typically contains 0.5% to 20.0% active ingredient by weight, ground calcium carbonate or rice hulls at 50–80%, mineral oil or soybean oil at 2–5%, silicon dioxide at 0.5–2.0% to control caking, and, where granulation is required, lignosulfonate binder at 1–3%. The dilution sequence is strictly geometric: a 1:10 first dilution with dry carrier is mixed in a 100 kg vertical screw mixer for 10 min, then a 1:10 second dilution is mixed in a 1000 kg double-ribbon mixer for 15–20 min, with the coefficient of variation of samples taken from 10 locations not exceeding 5.0%. In feed mills, the final inclusion rate in complete feed is commonly 0.1–5.0 kg/ton depending on the approved veterinary medicinal product label; therefore automatic micro-ingredient dispensers with load-cell accuracy of ± 0.25% and sequential flush timers are preferred over manual bag tipping. Regulatory anchors include EU Regulation 2019/4 for manufacture and use of medicated feed, 21 CFR 225 for current good manufacturing practice in medicated feed mills, and 21 CFR 226 for registration of feed mills and processors; cross-contamination validation should follow the site's HACCP plan under ISO 22000 or GMP+ BA2. For this downstream configuration, published data on residue carryover in complex multi-species feed lines is limited, so equipment-specific flush validation and swab sampling must be executed for every API changeover. Terminal finished forms include 1 kg, 5 kg, and 10 kg multilayer paper bags with polyethylene inner liners, granulated premix particles between 0.5 mm and 2.0 mm, and bulk silo-delivery premix for integrated swine and poultry operations.
In oral solution and drench manufacturing, the API powder is not simply dissolved; it is incorporated through a high-shear mixing train in which the sequence of addition, pH, and cosolvent concentration controls both chemical stability and microbiological robustness. The solution formula is prepared at an API concentration of 0.1% to 10.0% w/v, with propylene glycol or glycerol at 10–30% as cosolvent, sodium benzoate or potassium sorbate at 0.1–0.2% as preservative, citric acid or phosphate buffer at 0.05–0.5% to maintain pH between 4.5 and 6.5, sucralose or saccharin sodium at 0.05–0.1% for palatability in food-producing species, and methylcellulose or xanthan gum at 0.5–2.0% when a suspension or stabilised emulsion is required. Mixing is performed in a 500–2000 L stainless-steel tank with a high-torque propeller agitator at 200–500 rpm and a bottom-mounted homogenizer at 1500–3000 rpm for 15–30 min, while nitrogen blanketing at 0.5–1.0 bar is applied if the API exhibits oxygen-sensitive degradation. The bulk liquid is passed through a 5 µm polypropylene depth filter and then filled into type III glass or high-density polyethylene containers with an induction seal, with in-process pH held within ± 0.1 pH units and fill volume controlled by peristaltic pumps with ± 1.0% accuracy. Microbiological limits follow Ph. Eur. 5.1.4 for oral liquids, preservative efficacy follows Ph. Eur. 5.1.3 or USP <51>, and manufacturing is governed by 21 CFR 211 and EU Regulation 2019/6 for veterinary medicinal products. Terminal dosage forms include 50 mL, 100 mL, 500 mL, and 1 L oral drench bottles, 5 L flexibags for automated water proportioning, and concentrated oral solutions requiring dilution before intravenous or oral administration according to the label.
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Xinyi Powder Veterinary Grade API is supplied as a crystalline powder for direct incorporation into tablets, injections, capsules, oral powders, granules, premixes, and solutions. The product model designation covers a micronized variant for injectable and low-dose solid dosage forms and a granular variant for premix and granulation processes. Each lot is released against a certificate of analysis with specification attributes aligned to Ph. Eur. general chapters, USP general chapters, VICH GL18, and VICH GL23. The powder does not contain diluents, preservatives, or antimicrobial agents, and it is not a finished dosage form. Published multicentre data specific to this manufacturer's grade are limited; the following boundaries therefore derive from pharmacopoeial monographs, equipment-vendor operating data, and standard process-validation expectations. The primary differences from commodity feed-grade powders are the controlled particle-size distribution, polymorph certification, residual solvent reporting, and elemental impurity risk assessment required for pharmaceutical unit-dose manufacture.
For solid oral dosage forms, the powder is controlled by laser diffraction according to ISO 13320:2020 and, for coarse fractions used in premixes, by analytical sieving according to Ph. Eur. 2.9.12 or USP <786>. The certificate of analysis reports D10, D50, and D90 values, with route-specific acceptance windows. In direct-compression tablet formulations, a tight D90 limit reduces segregation during bin-blender discharge and lowers tablet weight variability at high rotary press speeds. The granular variant is agglomerated to lower dusting and improve flow in ribbon mixers and gravity-fed compression hoppers. Polymorph identity is confirmed by X-ray powder diffraction per Ph. Eur. 2.9.33; changes in polymorph can alter dissolution rate and oral bioavailability without changing HPLC assay. Feed-grade powders frequently lack polymorph documentation, and this creates batch-to-batch dissolution drift when the powder is used in tablets or capsules. Moisture content is tested by Karl Fischer titration per Ph. Eur. 2.2.32; for moisture-sensitive formulations, the powder should be dried before use if water content exceeds the certificate-of-analysis limit. The micronized variant increases available surface area and accelerates dissolution but may also increase electrostatic charging and adhesion to stainless steel contact surfaces. In low-humidity processing areas, ionization or slow addition to the blender may be required to reduce dust loss. For hopper design, flow function coefficient and wall friction angle may be measured by shear cell according to ASTM D6773-20; the resulting flow classification is used to set hopper angle and outlet diameter, but it is not a pharmacopoeial release test.
| Attribute | Test method designation | Route-specific application control |
|---|---|---|
| Particle-size distribution | ISO 13320:2020, Ph. Eur. 2.9.12, USP <786> | Micronized variant for injectable and low-dose solid routes; granular variant for premix and granulation |
| Solid-state form | Ph. Eur. 2.9.33 | Stable crystal form specified; amorphous content limited where dissolution is sensitive |
| Moisture content | Ph. Eur. 2.2.32, USP <921> | Control of moisture sorption; oral and premix grades may have wider limits than injectable |
| Assay | HPLC on dried basis | 98.0%–102.0% typical; route-specific justification under VICH GL2 |
| Related substances | Area-normalization HPLC | Unknown and total impurity thresholds; injectable grade commonly 0.05% and 0.10% |
| Residual solvents | VICH GL18, USP <467> | Class 1 and Class 2 solvents controlled by headspace GC |
| Elemental impurities | VICH GL23, USP <233>, Ph. Eur. 2.4.20 | Parenteral limits tighter than feed-premix limits |
| Bacterial endotoxins | USP <85>, Ph. Eur. 2.6.14 | Required for injectable route; not routine for oral solids |
| Finished-product particulate matter | USP <788>, USP <789> | Applies to injectable or ophthalmic finished product; API particulate load controlled |
| Content uniformity | Ph. Eur. 2.9.40, USP <905> | Validated on finished tablets/capsules; influenced by API particle size and blending |
Injectable solution manufacture requires a low-endotoxin API rather than oral-grade material. Bacterial endotoxins are determined by USP <85> or Ph. Eur. 2.6.14; the acceptance criterion is derived from the maximum veterinary dose and route of administration. Sub-visible particulate matter in the finished injection must meet USP <788> for large-volume injectables; the API contributes to particulate burden if milling residues, fibers, or foreign crystals are present. The injectable grade is therefore milled with metal separation and passed through a controlled-air sieving step, with residue on a 100 µm sieve specified on the certificate of analysis. Sterility is achieved downstream by aseptic filtration through a validated 0.22 µm membrane or by terminal sterilization; the API is not sterile as supplied. Terminal sterilization cycles are selected after thermal degradation data generated under VICH GL3 stability conditions. Solution clarity and color are also affected by elemental impurities and oxidation products; limit tests follow USP <233> or Ph. Eur. 2.4.20. For multi-dose injectable vials, antimicrobial effectiveness is tested on the finished product per USP <51> or Ph. Eur. 5.1.3, not on the API.
Assay is determined by HPLC on the dried basis; a specification of 98.0%–102.0% is typical for pharmaceutical-grade active ingredients unless a wider range is justified by process-validation data under VICH GL2. Related substances are controlled by area-normalization HPLC. For injectable grades, unknown impurities are commonly reported at 0.05% and total impurities at 0.10% unless otherwise justified; oral and premix grades may adopt the same thresholds or wider thresholds only with batch data and safety assessment. Residual solvents are controlled under VICH GL18 and USP <467>; Class 1 solvents require validated headspace GC, and Class 2 solvents are tested according to the solvent profile declared by the manufacturer. Elemental impurities are managed through the risk assessment described in VICH GL23 and measured by USP <233> or Ph. Eur. 2.4.20. The parenteral grade carries tighter limits for lead, cadmium, arsenic, and mercury than feed-premix grades because the injectable route bypasses first-pass metabolism and may be used in low-body-weight species. The difference from feed additive powders is that feed-grade material may report only assay and moisture, and may not include residual solvent, related substance, or elemental impurity release data. A formulation change from feed-grade API to this pharmaceutical-grade powder therefore requires re-verification of the impurity profile and, for food-producing animals, re-assessment of withdrawal periods under VICH GL49.
Across oral solid dosage operations, the powder is blended with excipients in tumble blenders, high-shear mixers, or ribbon blenders. The controlled D50 and bulk density reduce segregation during transfer from bin blender to compression hopper. Blend uniformity is evaluated by sampling multiple positions and testing content uniformity per Ph. Eur. 2.9.40 or USP <905>. For direct compression, the micronized variant is used when the final blend achieves acceptable flow after addition of glidant and lubricant; otherwise, wet granulation is preferred. In low-dose tablets, content uniformity below 2% relative standard deviation is commonly required, and this depends on matching the API particle size to the filler particle size to reduce ordered-unit segregation. For capsules, dosator and tamping-pin machines are sensitive to bulk density variations; the certificate of analysis reports tapped density and, where relevant, Hausner ratio according to Ph. Eur. 2.9.36 and USP <616>. For granules and premixes, the granular variant reduces dusting and improves flow through rotary sifters and screw conveyors. Liquid solutions are prepared by pH-controlled dissolution; the solid powder's dissolution profile is not used as a solution release test, but the manufacturing pH range must be validated to avoid precipitation of the free acid or base.
In solution manufacturing, the API is charged into a stirred vessel with the selected buffer or water for injection. The dissolution rate depends on temperature and pH; poor wetting can occur if the micronized powder is added too rapidly, forming a surface film that reduces yield. A pre-slurry step with a small portion of the aqueous phase is used on production scale to avoid lump formation. Filtration through a clarifying filter before sterile filtration is standard practice; the filter area and pressure drop are calculated from the particle load and batch volume. The micronized injectable grade reduces particulate load but does not remove the need for a 0.22 µm sterilizing filter. For oral solutions and liquid feed concentrates, the granular variant may be dissolved under continuous agitation; the pH must be maintained above or below the pKa of the active moiety depending on whether the salt form or free base is required. Solubility limits are temperature-dependent; cooling below 4 °C may cause precipitation in concentrated solutions. These processing parameters are standard for veterinary APIs and illustrate why the same powder cannot be used interchangeably across routes without route-specific validation.
When Xinyi Powder Veterinary Grade API is evaluated as a replacement for another active powder, the applicant should not assume a direct drop-in. The crystal form, particle-size distribution, and impurity profile may shift finished-product dissolution and stability. For tablets, comparative dissolution testing in target-species media is normally conducted according to Ph. Eur. 2.9.3 or USP <711>. For capsules and oral powders, blending time and shear intensity may require re-validation if the new API has a different electrostatic charge or bulk density. For injectables, pH, buffer capacity, and tonicity are re-checked because residual acid or solvent in the API can change solution pH. In premix applications, a stepwise geometric dilution is required when the active load is below 5% w/w. The granular variant's lower dusting and denser bulk character reduce cross-contamination in feed-mill addition. The controlled micronized powder is generally finer than commodity feed-grade API and may form dust clouds during open transfer; containment should meet ISO 14644-1 Class 8 or tighter depending on potency and operator exposure limits. This product's differentiation lies in multi-route release data and solid-state control rather than in direct formulation identity; it does not eliminate the need for process validation or finished-product testing.
At the warehouse and production line, the powder should be stored in tightly closed containers at 25 ± 2 °C and 60 ± 5% relative humidity unless the manufacturer's certificate of analysis states otherwise. Material exposed to ambient air above 60% relative humidity should be re-qualified for moisture content before weighing. Avoid blending the powder with strong oxidizing agents or with highly hygroscopic excipients unless the mixture is immediately processed and the packaging is sealed. Uncontrolled jet milling on site should not be carried out without reassessing particle size and polymorphic form because it can introduce amorphous content that alters dissolution. For injectable processing, the powder should be dissolved in a closed vessel with filtered air or nitrogen overlay if the solution is oxygen-sensitive. Working stock should be rotated by lot number; the manufacturer's retest date is based on stability data generated under VICH GL3 or equivalent. If the powder is used in sterile compounding, the downstream aseptic process and sterilizing filter compatibility must be validated with the specific filter membrane and container. These boundaries are process requirements for pharmaceutical-grade veterinary APIs generally, and they do not replace site-specific process qualification.
