| HS Code | 144972 |
| Product Name | Banerhuang Powder Veterinary Grade API |
| Product Type | Veterinary active pharmaceutical ingredient (API) |
| Veterinary Grade | Veterinary Grade |
| Physical Form | Dry powder |
| Solubility | Suitable for formulation into solutions; dispersion characteristics depend on the vehicle and pH |
| Dosage Form Compatibility | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Storage Conditions | Store in an airtight, light-protected, cool and dry place |
| Shelf Life | 24 months from date of manufacture under recommended storage |
| Microbial Limits | Meets veterinary pharmacopoeia requirements for specified microorganisms |
| Impurity Control | Controls for residual solvents, heavy metals, and related impurities per veterinary pharmacopoeia |
| Packaging | Sealed, moisture-resistant and light-resistant pharmaceutical packaging |
| Application | Used as active raw material for manufacturing veterinary dosage forms |
As an accredited Banerhuang 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 | Packaged in sealed, moisture-proof containers, supplied as 25 kg net per drum, with tamper-evident closure and full labeling for veterinary use. |
| Container Loading (20′ FCL) | Banerhuang Powder veterinary grade API packaged in sealed drums on pallets, loaded into 20′ FCL container for safe transport. |
| Shipping | Shipment of Banerhuang Powder Veterinary Grade API requires sealed, moisture-proof packaging to preserve stability. Transport in cool, dry, well-ventilated conditions, avoiding direct sunlight and extreme temperatures. Include Material Safety Data Sheet and proper labeling. Comply with veterinary pharmaceutical and hazardous goods regulations; handle with care to prevent dust exposure and contamination. |
| Storage | Store Banerhuang Powder Veterinary Grade API in a tightly sealed, moisture-proof container, away from direct sunlight and heat. Keep in a cool, dry, well-ventilated area at controlled room temperature. Avoid humidity and contamination. Always follow label instructions and ensure the storage area is secure, out of reach of children and animals. |
| Shelf Life | Shelf life generally spans 24 to 36 months when stored properly in sealed containers away from moisture, heat, and direct sunlight. |
Direct compression of Banerhuang Powder into veterinary oral tablets places the earliest process demand on particle size distribution, blend lubrication, and moisture control. A representative production frame uses 40.0% w/w Banerhuang Powder, 47.5% w/w microcrystalline cellulose PH102, 10.0% w/w crospovidone type A, 2.0% w/w sodium stearyl fumarate, and 0.5% w/w colloidal silicon dioxide. The API is pre-sieved through a 500 μm screen and pre-dried at 45 °C for 4 h when ambient relative humidity exceeds 55%. Blending is carried out in a V-blender at 25 rpm for 15 min; magnesium stearate is deliberately avoided below 0.5% w/w because over-lubrication reduces tablet tensile strength and slows disintegration. Compression is run on a rotary tablet press with 9 mm round tooling at 8–12 kN compression force and 30–60 rpm turret speed. In-process controls require hardness 80–120 N, friability below 1.0% according to Ph. Eur. 2.9.7, and mass uniformity acceptance value ≤15 according to USP <905>. Disintegration is tested in 900 mL water at 37 °C using Ph. Eur. 2.9.1 with a limit of ≤15 min. The terminal product is a conventional oral tablet for swine and poultry lines, with a defined rework limit of ≤2.0% w/w added dry rework to avoid blend segregation. Published data for this specific API in a direct compression frame is limited; the lubricant and disintegrant ratios are aligned with standard veterinary oral tablet production practice rather than a single commercial monograph.
| Control point | Lower boundary | Upper boundary | Processing consequence |
|---|---|---|---|
| Crospovidone % w/w | 5.0 | 10.0 | Below 5.0% disintegration exceeds 15 min; above 10.0% friability exceeds 1.0% |
| Compression force kN | 8 | 12 | Below 8 kN hardness falls below 80 N; above 12 kN capping risk increases |
| Final blend moisture % w/w | 2.0 | 3.5 | Below 2.0% capping risk; above 3.5% picking and sticking |
Wet granulation is introduced when the Banerhuang Powder bulk density falls below 0.35 g/mL or when direct compression fails mass uniformity. A binder solution of 5.0% w/w povidone K30 in purified water is added at 0.8–1.2 kg/min to a 25 kg batch in a high-shear granulator operating at 300 rpm impeller speed and 1500 rpm chopper speed. Wet massing continues for 4–6 min until torque rises 25–35% above the dry-mix baseline. The wet mass is transferred to a fluid-bed dryer with inlet air at 60 °C and product temperature maintained at 38–42 °C until loss on drying reaches 1.5–2.5% w/w. Dried granules are milled through a 0.8 mm conical screen. Final blending uses crospovidone and sodium stearyl fumarate at the same disintegrant and lubricant loadings as the direct compression frame, but compression force is increased to 12–18 kN to offset granule densification. Tablet hardness is controlled at 100–150 N. Aqueous film coating is applied with a 12% w/w Opadry II suspension to a 3.0% w/w weight gain at 65 °C inlet and 45 °C outlet air. The terminal product is a film-coated oral tablet for companion animal treatments, with release testing under 21 CFR 211.110 for in-process monitoring, USP <711> for dissolution, and ICH Q2 for analytical method validation. Amine-based binder systems are not used because residual alkalinity can shift the API microenvironment pH during storage.
Injectable solution processing of Banerhuang Powder requires a preformulation solubility screen because the parenteral route leaves no dissolution step to mask polymorph variability. A candidate formulation at 50 mg/mL Banerhuang Powder is prepared in Water for Injections with 0.01 M citrate buffer adjusted to pH 5.0, where the buffer is selected after a pH-solubility scan at 25 °C and 40 °C. For multi-dose vials, benzyl alcohol is added at 0.9% w/v; phenolic preservatives are avoided because they partition into silicone pump tubing at pH below 5.5. The bulk solution is sparged with filtered nitrogen for 15 min at 1 L/min to reduce oxidative degradation, then passed through a 0.22 μm PVDF membrane filter. Filter integrity is confirmed by bubble point above 3200 mbar. Terminal sterilisation is performed in a steam autoclave at 121 °C for 15 min, yielding a lethality accumulation F₀ ≥8 min. The solution is filled into 100 mL Type II glass vials under Class A aseptic conditions. Terminal product is an injectable solution for cattle or pig administration, with sterility tested according to Ph. Eur. 2.6.1 and endotoxin checked under Ph. Eur. 2.6.14. The formulation is not combined with strong oxidising agents unless a compatibility study confirms nil peroxide formation after 24 h at 25 °C. Published data for this specific API at other pH values is limited; the citrate system is a conservative starting point for a veterinary parenteral line.
For capsule filling, dry granulation via roller compaction is used when direct encapsulation fails due to low bulk density or poor flow. A 40.0% w/w Banerhuang Powder blend with 45.0% w/w lactose monohydrate 200M, 10.0% w/w microcrystalline cellulose PH102, 3.0% w/w croscarmellose sodium, 1.5% w/w colloidal silicon dioxide, and 0.5% w/w magnesium stearate is compacted at roll pressure 30–50 bar and milled through a 0.8 mm screen. Capsule filling is performed on a dosator machine with size 0 or 1 hard gelatin capsules, with weight variation acceptance value ≤15 under USP <905>. Dissolution is run in 900 mL of 0.1 M HCl at 50 rpm using USP <711> apparatus II. The terminal product is an oral capsule for companion animals; preconditioning of empty capsules at 35–45% RH is required to avoid shell brittleness.
Soluble oral powder production uses a separate carrier system because the API is dry-mixed with spray-dried lactose and sodium bicarbonate at 1.0% w/w to stabilise pH after reconstitution in drinking water. The blend is mixed in a ribbon blender at 15 rpm for 8 min, passed through a 710 μm screen, and packed in aluminium sachets at 1.0 kg unit size. The terminal product is a water-soluble oral powder for poultry drinking water lines; reconstitution clarity is checked at 20 g/L in tap water at 20 °C.
A 10.0% w/w intermediate premix is prepared by geometric dilution in four steps: 1:1, 1:3, 1:5, and 1:10 using a 500 L double-ribbon mixer operated at 15 rpm for 10 min after each addition. The carrier is lactose monohydrate or corncob meal with 0.5% w/w mineral oil as a dust suppressant. Premix homogeneity is monitored by sampling 10 locations across the mixer and analysing Banerhuang Powder content by HPLC; the relative standard deviation acceptance criterion is RSD ≤5.0% under USP <905> blend uniformity logic. Cross-contamination is controlled by a wash cycle between batches, with carryover limit set at ≤2.0% of the lowest active dose. The terminal product is a medicated feed premix for swine or poultry, with CGMP compliance anchored to 21 CFR 225.1 and 21 CFR 225.30 for premises, equipment, and mixing. When the premix is intended for ionophore-free feeds, the line is dedicated because trace detergents can alter electrolyte balance and reduce milling uniformity; published data for this specific API in ionophore combination is limited.
| Control point | Acceptance criterion | Method or standard |
|---|---|---|
| Premix homogeneity | RSD ≤5.0% | USP <905> blend uniformity |
| Residual moisture | ≤5.0% w/w | Ph. Eur. 2.2.32 |
| Particle size retention on 75 μm sieve | ≥75% | Ph. Eur. 2.9.38 |
| Carryover after wash | ≤2.0% | HPLC assay / 21 CFR 225.30 |
Oral granules are produced by extrusion-spheronization when the target species requires a feed-top brand that resists segregation. A wet mass is prepared with 20.0% w/w Banerhuang Powder, 35.0% w/w microcrystalline cellulose, 35.0% w/w lactose monohydrate, 5.0% w/w crospovidone, and 5.0% w/w povidone K30, adding purified water to a final moisture of 30.0–35.0% w/w. The mass is extruded through a 0.6 mm screen at screw speed 100 rpm in a basket extruder with 20:1 L/D ratio. Spheronization runs at 700 rpm for 3–5 min to generate pellets in the 0.8–1.2 mm range. Drying in a fluid bed at 55 °C inlet air reduces loss on drying to ≤2.0% w/w. Particle size distribution is checked by sieve analysis according to Ph. Eur. 2.9.38, with ≥90% w/w retained between 0.8 mm and 1.2 mm. Drying temperature is kept below 60 °C because localised overheating can fuse the povidone binder and produce hard pellets that fail disintegration. The terminal product is an oral granule for horses or cattle, mixed into feed immediately before administration. Friability and sphericity are monitored using a friabilator at 25 rpm for 10 min; pellet loss below 0.5% w/w is the release target.
Oral solutions require pH control and preservative selection because Banerhuang Powder is dissolved in a high-water-activity matrix that supports microbial growth. A 20 mg/mL oral drench is prepared by dissolving the API in purified water with 0.01 M citrate buffer at pH 4.5, adding sodium metabisulfite at 0.1% w/v as antioxidant and sodium saccharin at 0.05% w/v as palatability agent. The bulk solution is filtered through a 0.45 μm polypropylene filter and filled into 250 mL amber polyethylene terephthalate bottles with child-resistant caps. The terminal product is an oral solution for calves and lambs, with dosing by oral drench gun. Microbiological quality is controlled under Ph. Eur. 5.1.3 for oral liquids, and pH drift is limited to ±0.2 units over 24 months at 25 °C/60% RH. The solution is not blended with alkaline bicarbonate systems because rapid pH rise above 6.0 reduces chemical stability and may precipitate the API; published data for this specific configuration at higher pH is limited.
Competitive Banerhuang Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Banerhuang Powder Veterinary Grade API is supplied as a bulk active pharmaceutical ingredient for downstream formulation into tablets, injections, capsules, powders, granules, premix, and solutions. The current supplier does not assign a separate numerical model code; the full descriptor plus the certificate-of-analysis batch number functions as the procurement identifier. The material is released as a veterinary active substance, not as a finished dose form, and compendial tests are applied to the powder as a starting material. The API powder is manufactured under active pharmaceutical ingredient GMP conditions consistent with ICH Q7, and batch documentation includes identity, assay, related substances, residual solvents, water content, residue on ignition, heavy metals, particle size distribution, bulk and tapped density, and microbial quality. For parenteral applications, bacterial endotoxin data are added to the CoA. The powder should not be used in a given species without a veterinary regulatory file or prescribing veterinarian confirmation of the approved source.
Analytical release of non-sterile Banerhuang powder commonly follows USP <731> for loss on drying, USP <281> for residue on ignition, USP <231> for heavy metals, USP <616> for powder flow and density, and USP <429> for particle size distribution by laser diffraction. Assay and related substances are determined by HPLC using system suitability criteria that meet USP <621>. The control ranges shown in Table 1 are common release criteria for solid oral veterinary APIs; they are not universal pharmacopoeial limits and must be adjusted to the target species, dose, and finished product stability data. Particle size is treated as a critical quality attribute because D90 values above 150 µm can produce segregation in low-dose tablet blends and increase content uniformity failure risk under USP <905>. For injectable grades, the D90 is generally reduced to 75 µm or lower because finer particles shorten dissolution time and reduce filter loading during sterilizing filtration. The dispersing condition used for laser diffraction should be stated on the CoA; dry dispersion and wet dispersion may generate different apparent D90 values if the powder is hygroscopic or forms aggregates.
| Parameter | Compendial method | Common control range for solid oral veterinary API powder |
|---|---|---|
| Assay | USP <621> | 98.0–102.0% on dried basis |
| Loss on drying | USP <731> | ≤ 1.0% |
| Residue on ignition | USP <281> | ≤ 0.1% |
| Heavy metals | USP <231> | ≤ 20 ppm |
| Particle size D90 | USP <429> | ≤ 150 µm oral; ≤ 75 µm injectable |
| Bacterial endotoxins | USP <85> | ≤ 2.5 EU/mg for parenteral; dose-adjusted limit applies |
Residual solvents are controlled according to USP <467> or VICH GL18, and the CoA reports each solvent class limit. For products intended for oral administration in food-producing species, withdrawal period data are generated from the finished product, not from the API powder alone. API release data cannot establish a withdrawal interval; that requires tissue depletion studies in the target species. Water content is measured by Karl Fischer titration per USP <921> Method Ia when the powder is hygroscopic; loss on drying alone may overestimate water if volatile impurities are present. If the API is intended for aqueous solutions, the powder should be dissolved at the target concentration and the solution held for at least 24 h to detect precipitation or pH drift before large-scale compounding.
Feed-grade powders containing the same active molecule are not automatically equivalent to a veterinary API. The difference is the control state and intended regulatory use. Feed-grade materials are often released under feed hygiene controls and do not carry a full pharmacopoeial active ingredient dossier. They may have undefined related substances, higher heavy metal content, uncontrolled particle size distribution, and no bacterial endotoxin specification. Technical-grade powders are unsuitable for veterinary medicinal formulation because they are not manufactured under ICH Q7 and may contain process impurities that cannot be justified in a regulatory submission. Human-grade APIs are not automatically interchangeable with veterinary grades; species-specific excipient compatibility, palatability, residue depletion, and regulatory status must be evaluated for each formulation. Table 2 compares the control state of Banerhuang powder with feed-grade and technical-grade powders.
| Attribute | Banerhuang Veterinary API powder | Feed-grade powder | Technical-grade powder |
|---|---|---|---|
| Manufacturing basis | ICH Q7 API GMP | Feed hygiene control | Industrial chemical |
| Assay method | USP <621> | often not reported | not reported |
| Related substances | specified on CoA | not controlled | not controlled |
| Bacterial endotoxin | specified for parenteral grade | not specified | not specified |
| Use in sterile injection | possible after validation | not permitted | not permitted |
| Residual solvents | USP <467> / VICH GL18 | not specified | not specified |
The table is qualitative; a specific feed-grade lot may show acceptable assay but lacks the regulatory documentation to support veterinary drug use.
Direct compression of Banerhuang powder into tablets on a rotary press requires the powder to have adequate flow and compressibility. If the angle of repose exceeds 40° or the Carr index is above 25, direct compression may be replaced by dry granulation or wet granulation. Roller compaction is preferred for moisture-sensitive formulations because it avoids aqueous binder addition. Magnesium stearate is used at 0.5–1.0% as a lubricant, but extended mixing can form a hydrophobic film and reduce tablet dissolution; sodium stearyl fumarate at 1.0–2.0% is an alternative when the formulation is incompatible with magnesium ions. On high-speed rotary presses running at 60–80 rpm, a powder with a flow function coefficient below 4 can cause die filling variability; pre-compression force and excipient selection are adjusted to maintain weight variation below 1.5%. Powder flow is characterized before compression using the angle of repose, Carr index, and Hausner ratio. A Hausner ratio below 1.25 is generally free-flowing; above 1.4 indicates cohesive behavior that may require a force feeder or mechanical agitation. The choice of direct compression excipients is based on compatibility data; dibasic calcium phosphate, microcrystalline cellulose, and lactose monohydrate are common starting points, but amino or reducing sugar excipients should be avoided if forced degradation shows incompatibility. Batch-to-batch variance in moisture content is a common bottleneck on production lines because water above 1.0% can increase punch sticking and reduce tablet hardness at constant compression force. For low-dose capsules, the API is pre-blended with lactose monohydrate or microcrystalline cellulose by geometric dilution. Blend uniformity is assessed by sampling 10 locations and comparing assay results against USP <905> acceptance values for content uniformity. Drying of granules is conducted at inlet air temperatures below 60 °C unless forced degradation studies establish a higher threshold; published data for this specific API’s thermal degradation profile are limited, so the 60 °C value is a conservative starting point, not a product-specific limit. Automatic capsule machines require control of powder bed height, tamping force, and relative humidity; moisture pickup above 60% RH can increase sticking and weight variability.
When Banerhuang powder is incorporated into an injectable solution, the process must address sterility, particulate matter, and endotoxin. The API is dissolved in Water for Injection or a suitable non-aqueous vehicle; if solubility is low, pH adjustment or a co-solvent is used only after filter compatibility and stability are confirmed. Terminal sterile filtration through a 0.22 µm membrane is common for heat-labile active substances. Membrane type is selected from PVDF, PES, or nylon based on binding data; a 0.45 µm pre-filter is added when the bulk solution has high particulate load. Sterility is verified by USP <71> / Ph. Eur. 2.6.1, endotoxin by USP <85> / Ph. Eur. 2.6.14, and subvisible particles by USP <788> / Ph. Eur. 2.9.19. The powder itself is not by default sterile; if injectable manufacturing requires a sterile API, its sterility must be established separately or the bulk solution must be terminally sterilized. Aseptic processing requires the API to be handled in a controlled environment appropriate to the process, typically Grade A filling with Grade B or C background under EU GMP Annex 1. Published data for the specific sterile filtration capacity of this product are limited; membrane loading should be evaluated at pilot scale before production. Solution stability studies should include pH-rate profiles at room temperature and refrigerated storage. If the active moiety is sensitive to oxidation, nitrogen sparging and amber glass primary packaging are used; container closure integrity is verified according to USP <1207>. The final injectable product must also be tested for visible particulates by manual inspection or automated light obscuration; subvisible particulate counts are not a surrogate for visual inspection. The formulation should be protected from light if photodegradation is identified in ICH Q1B or VICH GL3 photostability testing.
Oral powders, granules, premix, and solutions require a different control strategy from tablets or injections. Premix production uses a double-cone blender, ribbon blender, or paddle mixer; mixing time and loading sequence are validated by sampling a tracer or the API itself. Geometric dilution is required when the API proportion is below 1% of total premix mass. Carrier particle size should be within a 1:3 ratio of the API D90 to reduce segregation during transport and storage. Ribbon blenders with working capacity of 100–500 kg are operated at 60–70% nominal fill for bulk premix; fixed mixing time is not a substitute for blend uniformity validation. Blend uniformity is assessed by collecting samples from 10 defined locations and comparing the coefficient of variation against the finished product specification. Dry powder segregation is controlled by matching particle size and density of the API and carrier. If the API has a D90 of 75 µm and the carrier has a D90 above 225 µm, the ratio exceeds 1:3; this increases segregation risk during discharge from bulk bags or silos. Electrostatic charging can also be a problem at low relative humidity; grounding of stainless steel contact surfaces and humidity control between 35–60% RH reduce adherence of fine particles to vessel walls. For oral solutions, the powder is dissolved in purified water or a buffered vehicle; chemical stability under ICH/VICH accelerated storage conditions establishes pH, oxygen, and light exposure limits. Non-sterile oral solutions must meet microbial quality standards according to Ph. Eur. 5.1.4 or USP <1111>; preserved solutions require challenge testing per USP <51> or Ph. Eur. 5.1.3. The powder is not a finished solution and should not be administered without a validated dilution or reconstitution protocol.
