| HS Code | 679338 |
| Product Name | Baifan Powder Veterinary Grade API |
| Common Name | Alumen (Alum) |
| Chemical Name | Potassium Aluminum Sulfate Dodecahydrate |
| Cas Number | 7784-24-9 |
| Molecular Formula | KAl(SO4)2·12H2O |
| Molecular Weight | 474.39 g/mol |
| Grade | Veterinary Grade |
| Appearance | White or colorless crystalline powder |
| Odor | Odorless |
| Solubility | Soluble in water; practically insoluble in ethanol |
| Acidity | Aqueous solution is acidic |
| Storage | Keep in a tightly sealed, moisture-proof container in a cool, dry place |
| Therapeutic Function | Astringent, antiseptic, hemostatic, and antidiarrheal agent |
| Dosage Form Applications | Tablets, injections, capsules, powders, granules, premix, and solutions |
As an accredited Baifan 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 | 25 kg net in sealed double polyethylene-lined fiber drums, protected from moisture, labeled for veterinary pharmaceutical manufacturing use. |
| Container Loading (20′ FCL) | 20′ FCL container loading of Baifan Powder veterinary grade API ensures safe, dry, sealed transport in lined drums or bags, protecting product integrity. |
| Shipping | Shipping for Baifan Powder Veterinary Grade API requires secure, moisture-proof packaging in sealed containers, labeled per customs regulations. International transport follows temperature-controlled, non-hazardous guidelines, with complete documentation. Delivery timelines vary by destination; refrigerated or expedited shipping available upon request to maintain product integrity. |
| Storage | Store Baifan Powder (Veterinary Grade API) in a tightly sealed, original container in a cool, dry, well-ventilated area. Protect from moisture, direct sunlight, and excessive heat. Keep away from incompatible substances, food, and animal feed. Maintain room temperature (20–25°C) unless otherwise specified. Ensure container is properly labeled and inaccessible to children and animals. |
| Shelf Life | Shelf life is 24 months in unopened original containers, stored dry, cool, and protected from light. |
Alumen (Baifan Powder, KAl(SO4)2·12H2O) enters oral tablet production as an astringent and local hemostatic active ingredient in veterinary gastroenterology. The crystals are first coarse-milled through a 0.5 mm screen and then jet-milled to a particle size D90 of 75 µm to 150 µm; larger platy particles reduce flow and produce weight variation above the 5% relative standard deviation threshold in high-speed rotary presses. Tablets are generally formulated by wet granulation because direct compression at active loadings above 20% w/w exhibits punch sticking at compression forces below 8 kN and capping above 15 kN. In a representative granulation, 300 mg Alumen per tablet is blended with microcrystalline cellulose 120 mg, maize starch 45 mg, crospovidone 25 mg, talc 5 mg and magnesium stearate 5 mg; the dry mix is granulated with 10% w/w solution of PVP K30 in purified water, wet-massed through a 1.0 mm screen, and tray-dried at 50 °C until the granule moisture specification is reached, because the dodecahydrate contains 45.57% w/w water of crystallisation and begins to dissolve in its own crystal water above 60 °C. The dried granules are compressed on a 10-station rotary tablet press with 10 mm flat-faced tooling to hardness 50–80 N. Each batch must pass disintegration under USP <701> in purified water at 37 °C with a limit of <15 min for immediate release, uniformity of dosage units under USP <905> with acceptance value ≤ 15.0, and loss on drying recorded by Ph. Eur. method 2.2.32. Incompatibility is observed with carbonate effervescent systems because the acidic pH of hydrated Alumen liberates CO₂; combination with phosphate-buffered carriers should be avoided because aluminium phosphate precipitation reduces drug availability. Terminal products include anti-diarrheal tablets for neonatal calves and piglets, often containing 200–300 mg Alumen per dose and labelled for oral administration only.
Preparation of alum-precipitated veterinary bacterins starts with sterile-filtered Alumen solution at 1–2% w/v in water for injection, prepared in a 316L stainless steel vessel and clarified through a 0.22 µm PVDF filter. The antigen concentrate—inactivated bacterial whole cells or purified toxoids—is standardised to a nephelometric cell count or protein content before the alum feed is dosed at 4–8 °C under continuous low-shear stirring. The addition ratio is fixed by the final Alumen concentration, commonly 2–10 mg/mL as KAl(SO4)2·12H2O; lowering the ratio to 1 mg/mL produces a weak floc network with poor antigen retention, while raising it above 15 mg/mL creates dense flocs that sediment in storage and complicate syringeability. After alum addition, pH is raised slowly with 0.1 M sodium hydroxide to 6.8–7.2, which converts soluble aluminium ions into aluminium hydroxide gel; the adsorption endpoint is monitored by centrifuging the suspension at 10,000 × g for 20 min and assaying residual protein in the supernatant by Bradford or bicinchoninic acid assay, with ≥ 80% protein depletion indicating acceptable precipitation. Excessive high-shear mixing after floc formation must be avoided because the rotor-stator head breaks the gel matrix and reduces antigen adsorption capacity. The final adjuvant suspension is filled into Type I glass vials under Grade C conditions, and each lot is tested for sterility by direct inoculation according to Ph. Eur. 2.6.1 or USP <71>, bacterial endotoxins by Ph. Eur. 2.6.14 with acceptance criterion <1 EU/dose, and aluminium content by complexometric titration against 0.1 M EDTA after acid digestion. Terminal products include injectable bacterins for bovine respiratory disease and ovine footrot, administered subcutaneously at volumes of 0.2–1.0 mL per site; published data for individual veterinary field isolates is limited, so the antigen-to-alum ratio must be revalidated for each strain bank.
In hard capsule and direct oral powder applications, Baifan Powder is formulated at active loadings of 5–15% w/w in glucose monohydrate or lactose carrier systems for poultry and swine. Because unmilled Alumen has an angle of repose above 45° and an apparent particle density of approximately 1.75 g/cm³, the API is first jet-milled to D90 ≤ 150 µm and preblended with 0.5–1.0% w/w fumed silica or 1.0% w/w magnesium stearate to improve flow through a V-blender operated at 60–70% capacity for 10–15 min. The powder is filled into size 1 or 2 hard gelatin capsules using a dosator-type capsule filler with compaction force set to 200–400 N; for sachet presentation, the blend is sealed in aluminium foil laminate at ≤ 40% relative humidity because the hydrated salt begins to cake above 75% RH. Blend uniformity is assessed by sampling 10 points across the batch and assaying aluminium by ICP-OES after microwave-assisted acid digestion; the acceptance criterion is relative standard deviation ≤ 5.0% under USP <905> principles. Capsule disintegration is tested under USP <701> with a 30 min limit in 0.1 M hydrochloric acid at 37 °C. The acidic microenvironment of dissolved Alumen can embrittle gelatin over storage; hydroxypropyl methylcellulose capsules or polyethylene glycol coating are used when prolonged tropical storage is required. Terminal products include 250 mg Alumen capsules and 1 g oral powders for piglets, labelled for short-course enteritis management and not for continuous feed use.
Alumen is incorporated into 5% w/w feed premixes and oral granules for group treatment in swine and poultry by first adsorbing the API onto a porous carrier such as corn cob meal or precipitated silica at 5–10 g Alumen per 100 g carrier. The premix is then dry-blended in a double-ribbon mixer for 8–10 min. Water is sprayed at 8–12% w/w of total batch weight to form small agglomerates; wet mass is passed through a 1.5 mm screen and dried in a fluid-bed dryer at 45 °C to residual moisture ≤ 5% w/w. Drying above 60 °C releases crystal water and creates a sticky bed that clogs distributor plates. The dried granules are classified between 0.5 mm and 1.5 mm and packaged in multi-wall paper bags with 0.08 mm polyethylene liner. Homogeneity testing follows the sampling plan of ISO 6497, with aluminium assay by ICP-OES after microwave-assisted nitric acid digestion; the batch is rejected if any of 10 sampling points falls outside ±10% of declared aluminium content or if relative standard deviation exceeds 5.0%. Aluminium ions migrate slowly in the dry premix but become mobile when moisture exceeds 10% w/w; therefore, product is not blended with dicalcium phosphate or sodium bicarbonate carriers because aluminium phosphate precipitation and acid-base reaction reduce chemical stability. Regulatory compliance for export premixes must distinguish between a veterinary medicinal premix governed by Directive 2001/82/EC and a feed material used as a technological additive; importers must confirm registration status in target markets and comply with the relevant Alumen monograph of the Chinese Veterinary Pharmacopoeia plus national feed safety codes. Terminal products include 5% w/w feed premix for medicated feed in poultry and swine, and 20% w/w oral granules reconstituted in drinking water for group therapy under veterinary prescription.
| Parameter | Acceptable limit | Analytical method |
|---|---|---|
| Particle size D90 | 75–150 µm | Laser diffraction per ISO 13320:2020 |
| Residual moisture | ≤ 5.0% w/w | Loss on drying at 105 °C |
| Mix uniformity | RSD ≤ 5.0% | ICP-OES after acid digestion, 10 sampling points |
| Carry-over aluminium | ≤ 0.2% dietary DM | ICP-MS in finished feed |
A 1% w/v solution of Baifan Powder in purified water produces pH 2.8–3.5 because of aluminium ion hydrolysis; if the solution is used without buffering for oral ulcer irrigation or post-surgical lavage, the acidity causes mucosal irritation and may leach aluminium from Type II glass containers. The solution is therefore prepared by dissolving Alumen in warm purified water at 40–50 °C, cooling to 20–25 °C, and filtering through a 0.45 µm nylon membrane to remove insoluble particles. Sodium acetate buffer is added to raise pH to 3.8–4.2; above 4.5 aluminium hydroxide precipitates as a visible white floc that reduces astringent availability and clogs spray nozzles. Solutions intended for sterile use are filled into Type I borosilicate glass or high-density polyethylene bottles and autoclaved at 121 °C for 15 min; terminal sterilisation after buffering is limited to 1 L containers because larger volumes require extended equilibration times that exceed F₀ 8 min. Compatibility testing has shown that benzalkonium chloride at 0.02% w/v can be included as a preservative in multi-dose dermal sprays, but chlorhexidine gluconate should be avoided because it forms a poorly soluble aluminium-chlorhexidine complex. The finished solution is tested for pH by USP <791>, microbial enumeration by USP <61> and USP <62>, and aluminium content by ICP-OES according to ISO 11885:2007. Terminal products include 0.5–1.0% w/v Alumen irrigation solution in 20 L jerrycans for topical astringent treatment of dermatophytosis, hoof bath, and oral mucositis; sterile solutions must be pyrogen-tested and are not intended for deep tissue injection.
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Baifan Powder Veterinary Grade API is released as a white to off-white crystalline active substance for downstream formulation into tablets, injections, capsules, powders, granules, premixes, and solutions. The certificate of analysis carries a model designation that encodes the intended physical processing route: BF-VAPI-25/75 for dry blending and capsule filling, BF-VAPI-M for micronized suspension and solution processing, and BF-VAPI-P for premix and granule manufacture. The suffix does not imply a different chemical purity; all models are required to meet the same assay and related-substance limits unless a specific dossier specifies otherwise.
Each batch is released under Good Manufacturing Practice for active substances used in veterinary medicinal products and is not intended for direct administration without a finished-product marketing authorization for the target species. The multi-route release specification distinguishes the material from single-route active powders and feed-grade additives by requiring simultaneous control of identity, assay, related substances, residual solvents, elemental impurities, microbial quality, and, where the injectable route is claimed, bacterial endotoxin and sub-visible particulate matter.
For dry oral solid operations, particle-size distribution is determined by laser diffraction using ISO 13320:2020 and reported as D10, D50, and D90. The BF-VAPI-25/75 grade is controlled to a mass-median diameter of 25–75 µm; the D90 is monitored to detect over-milling and the associated increase in electrostatic charging. Bulk density and tapped density are measured according to Ph. Eur. 2.9.34 or USP ⟨616⟩, from which the Hausner ratio and Carr index are calculated. A loss-on-drying limit of ≤1.0% is controlled by Ph. Eur. 2.2.32 or USP ⟨731⟩. Identity is confirmed by infrared absorption spectrophotometry against a qualified reference standard using Ph. Eur. 2.2.24 or USP ⟨197K⟩. Assay is performed by a stability-indicating HPLC method; the release window is set in the approved dossier and is typically 98.0–102.0% on the dried basis. Related substances are quantified by the same HPLC method under VICH GL11; unspecified impurities are controlled to ≤0.10% unless justification is provided under the impurity guidance applicable to the target species.
The compressibility of the API is assessed by compaction simulation across a range of 10–200 MPa. The resulting Heckel plot and tensile strength data determine whether the API can be used in direct compression or requires wet granulation. For the BF-VAPI-25/75 grade, tensile strength at 150 MPa compaction pressure is recorded as an internal lot-release check; the value is used to detect changes in crystal habit that are not visible by particle-size distribution alone. If the tensile strength falls below the internal control limit, the lot is re-evaluated for wet granulation or roller compaction. In direct compression, the flow function coefficient of the final blend is measured by ring shear testing; a value below 4.0 generally requires the addition of a glidant or a switch to roller compaction. The powder is blended in a twin-shell V-blender or bin blender at 50–70% of rated capacity; intensifier-bar activation is limited to ≤10 min to prevent particle attrition and segregation. For capsule filling, powder plug formation is evaluated on a tamping-pin or dosator-type capsule machine. Fill weight variability is tracked across ≥100 capsules per sampling interval; the acceptance limit is defined by the finished-product dossier, and the API contributes to variability only when its bulk density changes by more than ±10% between batches.
| Test | Method | Route-specific control |
|---|---|---|
| Particle size distribution | ISO 13320:2020 / Ph. Eur. 2.9.31 | D50 25–75 µm for BF-VAPI-25/75; D90 ≤15 µm for BF-VAPI-M |
| Bulk and tapped density | Ph. Eur. 2.9.34 / USP ⟨616⟩ | Hausner ratio and Carr index recorded for dry blend |
| Loss on drying | Ph. Eur. 2.2.32 / USP ⟨731⟩ | ≤1.0% for oral solid processing |
| Identification | Ph. Eur. 2.2.24 / USP ⟨197K⟩ | positive match to reference standard |
| Assay | stability-indicating HPLC | 98.0–102.0% dried basis, as dossier-defined |
| Related substances | stability-indicating HPLC | unspecified impurities ≤0.10% |
| Residual solvents | VICH GL18 / Ph. Eur. 2.4.24 / USP ⟨467⟩ | Class 1 solvents not detected; Class 2 within dossier limits |
For injectable solution and suspension manufacturing, the BF-VAPI-M micronized grade is subjected to a different control hierarchy. Bacterial endotoxin is determined by Ph. Eur. 2.6.14 or USP ⟨85⟩; the acceptance criterion is calculated from the maximum daily dose and the species-specific endotoxin limit, not from a single universal powder specification. Sub-visible particulate matter in the reconstituted or final solution is evaluated according to USP ⟨788⟩ or Ph. Eur. 2.9.19. Sterility assurance is achieved by terminal sterilization or aseptic filtration; if the solution is filtered through a 0.22 µm membrane, filter compatibility, adsorption, and extractables are assessed at low API concentrations and with any co-solvent system. The powder must disperse without forming agglomerates larger than the defined particle-size limit for the route; wet milling or high-shear dispersion may be required for suspensions.
Depyrogenation of the API is not applied as a routine destructive powder treatment unless the active substance is thermostable and the dossier supports dry-heat or validated solvent-mediated endotoxin reduction. Instead, endotoxin control is process-based: the API is crystallized, dried, and packaged in clean areas classified under ISO 14644-1; water used for final recrystallization is controlled for endotoxin; and product-contact surfaces are depyrogenated where required. Published data for this specific configuration is limited when non-aqueous co-solvents are used, because endotoxin recovery and assay interference vary with solvent composition; each finished-product dossier must therefore establish its own validated endotoxin test conditions.
Microbial quality for non-sterile oral powders and premixes is controlled by Ph. Eur. 2.6.12 or USP ⟨61⟩/⟨62⟩. The acceptance limits for total aerobic microbial count, total yeast and mold count, and specified pathogens are defined by the intended route and the pharmacopoeial monograph. For sterile injectable presentation, the finished product is tested for sterility according to Ph. Eur. 2.6.1 or USP ⟨71⟩; the API powder is not automatically sterile, and the downstream manufacturer must establish a terminal sterilization or aseptic process. The powder’s particle-size distribution can affect sterilizing-grade filter capacity; micronized material with a high fine fraction may increase membrane fouling, so a prefilter or depth filter is often used ahead of the final 0.22 µm membrane.
Premix and oral granule manufacture requires control of blend segregation and moisture migration after dilution into feed matrices. The BF-VAPI-P grade is produced with a controlled sieve fraction that reduces sifting segregation when diluted from 1:100 to 1:1000 with mineral or organic carriers. Hygroscopicity is assessed by dynamic vapor sorption at 25 ± 0.1 °C; if moisture uptake exceeds 2.0% at 60% RH, open handling is restricted to ≤40% RH or dry-nitrogen blanketing is required. Oxidation-sensitive formulations are protected by opaque packaging and oxygen-absorbing sachets; light exposure is evaluated under ICH Q1B conditions adapted for veterinary products. The powder is not released on tracer assays alone; batch-wise assay and related-substance data are required to confirm that the active substance survives the thermal and mechanical stresses of steam conditioning and pelleting if these unit operations are used in medicated feed.
In oral solutions, the API is dissolved or suspended in a buffered vehicle. The pH range is chosen from the solubility profile and degradation kinetics; because solution pH, buffer species, and headspace oxygen differ across formulations, published data for this specific configuration is limited. Each finished-product dossier establishes its own stability-indicating limits, and the API certificate of analysis provides only the solid-state purity and solubility data necessary for formulation screening.
Under routine production conditions, dry granulation by roller compaction may be used for higher drug loads; the ribbon density is controlled to 0.9–1.1 g/cm³, and milled granules are classified through a 1.0 mm screen. For wet granulation, the powder is combined with a binder solution in a high-shear granulator. Granulation end point is controlled by impeller power consumption or torque rather than fixed time; dried granules are milled and screened. Residual moisture after fluid-bed drying is maintained at ≤2.0% for capsule and tablet compression unless the formulation is moisture-sensitive.
Residual solvent and elemental impurity control follows VICH GL18 and, where applicable, Ph. Eur. 2.4.24, USP ⟨467⟩, Ph. Eur. 2.4.20, and USP ⟨232⟩/⟨233⟩. Class 1 solvents are not detected; Class 2 solvents are controlled to the permitted daily exposure derived from the maximum veterinary dose. Elemental impurities are assessed as part of the finished-product risk assessment; the API is typically not the dominant source unless the manufacturing process uses metal catalysts or mineral acids. When the API is used in injectable formulations, the cadmium, lead, arsenic, and mercury limits are tighter than those for oral powders; the exact limits are determined by the route, species, and daily dose.
On production-scale lines, the primary batch-to-batch variability risk is not chemical assay but physical consistency. Batch records from multi-product oral solid facilities indicate that direct compression is most sensitive to changes in the API particle-size distribution and residual moisture. A shift of D50 from 25 µm to 75 µm within the release range can alter tablet hardness and disintegration time when the API is poorly compactible and represents more than 20% of the tablet weight. For this reason, the BF-VAPI-25/75 grade is released with a narrower internal control range than the compendial acceptance range, and the difference between the upper and lower D50 lot averages is recorded on the certificate of analysis. In high-shear wet granulation, a loss-on-drying value above 1.5% after drying can produce ribbon sticking or punch filming during subsequent compression; the API specification therefore supports the drying endpoint rather than substituting for it.
Replacement of a single-route active powder with Baifan Powder Veterinary Grade API on existing tableting, encapsulation, or filling lines requires a technical-transfer assessment. The powder may differ from the incumbent material in particle morphology, bulk density, and electrostatic charging tendency; these differences affect die fill, powder plug formation, and blend segregation. The main distinction from feed-grade or technical-grade powders is that Baifan Powder Veterinary Grade API carries route-specific release data and a documented impurity profile under VICH GL11. It is not released solely on micronutrient or tracer assays; it is controlled for residual solvents under VICH GL18 or Ph. Eur. 2.4.24 / USP ⟨467⟩, for microbial quality under Ph. Eur. 2.6.12 or USP ⟨61⟩/⟨62⟩, and for endotoxin under Ph. Eur. 2.6.14 or USP ⟨85⟩ when the injectable route is claimed. The comparison below summarizes the route-related control differences.
| Parameter | Baifan Powder Veterinary Grade API | Single-route oral API | Feed-grade additive powder |
|---|---|---|---|
| Particle-size reporting | ISO 13320:2020 with D10, D50, D90 | dossier-defined only | sieve cut only |
| Endotoxin control for injectable use | validated Ph. Eur. 2.6.14 / USP ⟨85⟩ | not routine | not applicable |
| Residual solvents | VICH GL18 / Ph. Eur. 2.4.24 / USP ⟨467⟩ | limited | often absent |
| Microbial quality | Ph. Eur. 2.6.12 / USP ⟨61⟩/⟨62⟩ for non-sterile; Ph. Eur. 2.6.1 / USP ⟨71⟩ for sterile claim | may be limited | total CFU label only |
| Batch release | full certificate of analysis with assay, related substances, residual solvents, elemental impurities | partial certificate of analysis | feed label |
The multi-route claim creates additional responsibilities compared with a single-route active substance. A powder sold only for oral use may not require endotoxin or particulate matter data; a powder sold only for feed premix may not require full related-substance or residual-solvent profiling. Because Baifan Powder Veterinary Grade API is released for all seven presentations, the batch records must demonstrate that the same synthesis and purification sequence can meet the strictest route-specific limit. In practice, this means the injectable-grade endotoxin and particulate requirements drive the cleaning, packaging, and filtration steps even for lots that will ultimately be used in oral granules or premixes.
Cleaning validation on multi-product veterinary facilities is performed using swab and rinse sampling; the acceptance limit is derived from the permitted daily exposure and the smallest batch size. The API powder has a low aqueous solubility at neutral pH, so cleaning may require an alkaline or surfactant-containing wash step; the clean-in-place cycle is validated by total organic carbon and HPLC rinse samples. If the powder is micronized, containment in a downflow booth or isolator is required to keep operator exposure below the occupational exposure limit; the specific limit is derived from toxicological data and is not set by this product monograph.
The material should be stored in sealed original packaging at a temperature of 15–25 °C, protected from light and moisture. Once opened, the container should be reclosed under dry nitrogen if the relative humidity exceeds 60%. Combination with amine-based additives or strongly alkaline excipients may promote degradation or salt disproportionation if the active substance is a weak acid or base; compatibility screening by differential scanning calorimetry and isothermal stress testing is required before formulation. The powder is not intended for use in medicated feed without a licensed premix step, and it is not a sterile raw material unless the batch is specifically released as a sterile injectable-grade powder after validated sterilization or aseptic processing.
