| HS Code | 994301 |
| Product Name | Artificial Mineral Salt Veterinary Grade API |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Chemical Identity | Purified artificial mineral salt mixture containing sodium, potassium, calcium, magnesium, chloride, phosphate, and bicarbonate salts |
| Appearance | White or almost white crystalline powder |
| Odor | Odorless or faint saline odor |
| Solubility | Freely soluble in water; practically insoluble in ethanol and acetone |
| Ph 5 Percent Aqueous Solution | 6.0 to 8.5 |
| Sodium Content | 5.0% to 20.0% w/w |
| Potassium Content | 0.2% to 2.5% w/w |
| Calcium Content | 0.5% to 2.0% w/w |
| Magnesium Content | 0.1% to 1.0% w/w |
| Veterinary Grade Compliance | Complies with veterinary pharmacopoeia standards for oral and parenteral formulations |
As an accredited Artificial Mineral Salt 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 25 kg net weight: double food-grade polythene liners inside sealed fiber drum, with tamper-evident closure and labeled certificate. |
| Container Loading (20′ FCL) | Loading of 20′ FCL: Artificial Mineral Salt Veterinary Grade API, packed in drums/bags for various formulations, secured for shipment. |
| Shipping | Shipping of Artificial Mineral Salt Veterinary Grade API requires compliance with local and international regulations. Pack in sealed, moisture-proof containers, labeled appropriately. Avoid exposure to extreme temperatures. Use certified carriers experienced with pharmaceutical chemicals. Ensure documentation includes SDS, certificate of analysis, and customs declarations for safe, traceable delivery. |
| Storage | Store in a cool, dry, well-ventilated area, tightly sealed in original, labelled containers. Protect from direct sunlight, excessive heat, and moisture – as hygroscopic material. Keep away from oxidizing agents and incompatible substances. For sterile injectable grades, maintain aseptic conditions. Ensure strict compliance with veterinary pharmaceutical regulations, use appropriate containment, and rotate stock to prevent degradation. |
| Shelf Life | Shelf life: 24 months from manufacture date when stored in original, tightly sealed container under cool, dry conditions. |
During aseptic compounding of injectable electrolyte solutions for large animal fluid therapy, the artificial mineral salt veterinary grade API is dissolved in Water for Injections under nitrogen blanketing to prevent atmospheric CO₂ uptake and subsequent pH drift. The total mineral salt addition ratio is typically 4.5–9.0 g/L, adjusted so that the finished solution delivers 130–140 mmol/L Na⁺, 4–5 mmol/L K⁺, and 1.5–2.2 mmol/L Ca²⁺, with osmolality maintained at 280–320 mOsm/kg. Compliance for this application is governed by Ph. Eur. 0520, sterility confirmation under Ph. Eur. 2.6.1/USP <71>, bacterial endotoxin testing under Ph. Eur. 2.6.14/USP <85>, and elemental impurity control under ICH Q3D Option 1, where parenteral PDE limits for cadmium and lead are 2 µg/day and 5 µg/day respectively. Production-scale batching in 5,000 L stainless steel 316L vessels fitted with top-driven pitched-blade impellers at 80–120 rpm achieves complete dissolution within 25–35 min; bottom-mounted magnetic stirrers have shown assay RSD above 1.0% at 20°C because of dead zones near the vessel base. The bulk solution is passed through 0.22 µm membrane filters into Grade A unidirectional airflow under ISO 14644-1 Class 5 conditions and terminally sterilised at 121°C for 15 min where bicarbonate is absent. Formulations containing sodium bicarbonate are not terminally autoclaved under standard conditions because CO₂ evolution shifts pH and may rupture sealed containers; these require aseptic filtration or processing under CO₂ headspace with separate acid and base compartments. Calcium- and phosphate-containing formulas present additional compatibility limits, as brushite or hydroxyapatite precipitation occurs above pH 6.5 and at calcium concentrations above 2.5 mmol/L. Finished presentations include 500 mL and 1,000 mL PVC-free polyolefin bags, 250 mL vials, and 5 mL ampoules for small animal bolus injection.
Oral rehydration granules containing the artificial mineral salt veterinary grade API are designed to deliver 50–90 mmol/L Na⁺, 20–30 mmol/L K⁺, and 30–40 mmol/L base equivalent after reconstitution at 4.0–7.0 g/L dry mineral salt API, with final osmolality held at 280–310 mOsm/kg to prevent abomasal dumping. The dry granule addition ratio before filling is 30–50% w/w mineral salt API, 20–25% w/w dextrose monohydrate, 10–15% w/w glycine or citrate buffer, and 1–3% w/w binder. Compliance is established under Ph. Eur. 1165, USP <731> for loss on drying, USP <786> for particle size by analytical sieving, and ICH Q7 for API handling. In fluidised-bed granulation, top-spray units with inlet air temperature 55–65°C and product temperature 28–32°C yield granules with moisture <1.0% w/w and sieve fraction 150–710 µm; moisture above 1.5% w/w accelerates deliquescence of chloride-containing mineral salts and causes sachet-end clumping. The reconstitution behaviour in field water with bicarbonate hardness above 100 mg/L CaCO₃ is the main stability bottleneck: poorly dispersed granules form floating aggregates, and carbonate salts precipitate as cloudiness after 30 min. The manufacturing remedy is to include 0.1–0.2% w/w hydrated silica as anti-caking agent and replace sodium bicarbonate with sodium citrate in the buffering system. Finished products are packed as 10 g, 20 g, and 50 g laminated foil sachets for oral drench administration to calves, lambs, and kids.
Preparation of trace mineral premixes for swine and poultry requires the artificial mineral salt veterinary grade API to be pre-milled through a 1.5 mm hammer mill screen and blended with a ground limestone or wheat middling carrier at 100–250 g/kg premix inclusion to give 0.5–5.0 kg/t complete feed addition depending on the target trace element concentration. Compliance for this route is anchored to Regulation (EC) No 1831/2003 for feed additives in the functional group of nutritional additives, Regulation (EC) No 183/2005 on feed hygiene, and ISO 22000 food safety management for feed mills. The downstream production sequence uses microdosing accuracy better than 0.5% of batch size, a 2,000 L plow mixer with 20–30 min mixing time, and a counterflow cooler that reduces granule temperature below 35°C before bagging. The primary process failure at production scale is wall fouling and caking when ambient relative humidity exceeds 40% RH or when the API contains magnesium chloride species with deliquescence points below 30% RH; therefore weigh hoppers are fitted with silica gel breathers and compressed air dryers meeting ISO 8573-1 class 2.2.2 for conveying. Terminal finished goods are 1% and 5% trace element premixes in 25 kg paper bags with PE liners, 1,000 kg big bags, and top-dress mineral packs.
| Control point | Method/Standard | Acceptance criterion |
|---|---|---|
| Heavy metals | ICH Q3D Option 1 oral PDE / ICP-MS | Cd 5 µg/day, Pb 5 µg/day, As 15 µg/day, Hg 30 µg/day |
| Blend uniformity | ICP-OES on 10 stratified samples | 90.0–110.0% label claim, RSD <5% |
| Moisture | USP <731> | <1.0% w/w |
| Particle size | USP <786> | 90% between 150–710 µm |
Water-soluble mineral salt powders for poultry drinking water are formulated with the artificial mineral salt veterinary grade API at 0.5–1.5 g/L final drinking water, typically as a 100 g sachet for 200 L stock solution. Compliance applies Ph. Eur. 1165 for oral powders, USP <731> for moisture, and USP <1174> for powder flow; when the powder is presented as a liquid concentrate, Ph. Eur. 0520 is not applicable and the product is controlled under oral solution specifications in current pharmacopoeial monographs. The downstream production process is dry blending in a ribbon mixer followed by humidity-controlled filling at ≤30% RH, because the API fraction contains sulfate and carbonate species that absorb moisture and form strong bridges in auger sachet fillers. Field performance in hard water with CaCO₃ equivalent above 150 mg/L is the critical dissolution limit: precipitation of calcium sulfate and calcium carbonate occurs within 10–20 min if alkalinity is above 180 mg/L HCO₃⁻ and the formulation lacks an acidifier. To maintain solubility, citric acid or sodium acid pyrophosphate is incorporated at 1–3% w/w of the finished powder to depress reconstituted pH to 5.5–6.5; chelating agents such as disodium EDTA at 0.05–0.1% w/w are used only where regulatory food additive permissions allow. The finished product types include 100 g and 1 kg PET/Al/PE sachets for water medication, 5 L HDPE jerrycans of concentrated liquid stock, and 25 kg bulk bags for large poultry integrators.
Formulation of intraruminal boluses for trace element supplementation in cattle and sheep uses the artificial mineral salt veterinary grade API at 5–15% w/w in a 30–50 g direct-compression matrix containing 10–20% w/w hypromellose or sodium alginate release modifier and the balance of densified dicalcium phosphate or microcrystalline cellulose. Compliance is assessed under Ph. Eur. 0478, USP <1217> for breaking force, Ph. Eur. 2.9.7 for friability, and USP <711> for dissolution where a published monograph exists; comparator dissolution profiles are generated in-house under biorelevant conditions when no monograph is available. On rotary tablet presses fitted with 19 mm flat-faced tooling, compression force is maintained at 20–30 kN, yielding hardness 80–120 N and friability <1.0%; ejection force increases sharply when magnesium stearate exceeds 1.0% w/w or when API particle size distribution shifts below 100 µm across more than 50% of the batch. The controlled-release mechanism in the rumen relies on hydration and surface erosion of the matrix rather than rapid disintegration, so in vitro release testing in 0.1 N HCl or acetate buffer at pH 5.5 typically shows 20–40% release at 24 h and 60–90% release at 120 h for sheep-sized boluses. Finished presentations are 30 g, 75 g, and 100 g intraruminal boluses, usually administered via balling gun, with an in-rumen residence time of 180–365 days depending on density and matrix composition.
In companion animal capsule filling, the mineral salt API is premixed with microcrystalline cellulose and a bitter-masking excipient before encapsulation, with the API addition ratio set at 20–40% w/w of the 250–500 mg fill weight and magnesium stearate limited to 0.5–1.0% w/w. The operation falls under Ph. Eur. 0016 for capsule content uniformity, USP <711> or Ph. Eur. 2.9.3 for dissolution, and USP <921> for water determination if the salt hydrate form is used. Production-scale encapsulation on tamping-pin machines running at 60,000–100,000 capsules/hour is stable only when granule bulk density is 0.55–0.75 g/mL and angle of repose is <35°; otherwise fill weight RSD exceeds 3% and capsule shell splitting occurs with hygroscopic mineral salts above 40% RH. The dry granulation route through roller compaction at 20–30 kN/cm roll pressure followed by sieving to 250–850 µm produces higher density granules and reduces dust generation compared with direct fill. Finished dosage forms are size 0 or size 1 hypromellose capsules containing 250 mg or 500 mg of mineral salt API blend, packed in 60 and 120 count HDPE bottles with desiccant canisters.
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Artificial mineral salt veterinary-grade API is supplied as a defined multi-electrolyte inorganic matrix for incorporation into veterinary medicinal products intended for tablets, injections, capsules, powders, granules, premix, and solutions. Two model designations are assigned by route: AMS-VG-7 for oral solid and premix presentation, and AMS-VG-9 for injectable and sterile solution presentation. The material is not a feed-grade mineral premix; it is manufactured under a pharmaceutical quality system aligned with EU GMP Part II and ICH Q7, with purity specifications derived from current European Pharmacopoeia and United States Pharmacopeia general chapters. Primary ionic species are sodium, potassium, calcium, and magnesium as chloride or sulfate salts, with the exact stoichiometric ratio selected according to formulation type. Product specification covers appearance, identification of each cation and anion, loss on drying, pH of a defined aqueous solution, elemental impurities under ICH Q3D, residual solvents under VICH GL18, and microbial quality. For oral dosage forms, the API is tested for content uniformity after geometric dilution under Ph. Eur. 2.9.40 or USP <905>. For parenteral presentations, the API is tested for bacterial endotoxins and subvisible particulate matter before terminal sterilization or aseptic filling. Differentiation from natural mineral salt sources is achieved by defined stoichiometry, absence of insoluble silicates and organic matter, and tighter limits on lead, cadmium, arsenic, and mercury.
Tablet manufacture with AMS-VG-7 is governed by particle-size distribution, residual moisture, and gravity flow. The compendial specification for loss on drying by Ph. Eur. 2.2.32 is set at ≤ 1.0% because higher free moisture promotes punch filming and capping at turret speeds above 30 rpm on rotary tablet presses. Tapped density by Ph. Eur. 2.9.34 is controlled within 0.80 g/cm³ to 1.05 g/cm³; values below 0.80 g/cm³ are associated with die-fill variation exceeding 3% relative standard deviation on high-speed rotary presses without forced feeder assistance. Laser diffraction particle sizing per Ph. Eur. 2.9.3 is used to hold the median particle size, D50, between 150 μm and 250 μm. When D50 exceeds 250 μm, direct compression blends containing 15% to 25% API exhibit segregation and poor content uniformity under USP <905>. Conversely, when D50 falls below 100 μm, dry mixing generates static charge and gravity flow decreases, requiring dry granulation by slugging or roller compaction. The API is compatible with microcrystalline cellulose, lactose monohydrate, and croscarmellose sodium in direct compression; however, pregelatinized starch above 20% w/w can initiate moisture transfer during storage and should be assessed under ICH Q1A(R2) stability conditions. In tablet formulations, the salt matrix does not require pregelatinized starch or super-disintegrant levels above 5% w/w because the inorganic components dissolve rapidly in aqueous media; disintegration time by Ph. Eur. 2.9.1 is typically below 15 minutes for uncoated tablets in water at 37°C.
Capsule filling with AMS-VG-7 uses the same particle-size specification but with tighter control of bulk density because metering by tamping pins is sensitive to over-lubrication. Magnesium stearate at 0.5% to 1.0% w/w is usually sufficient; blending beyond 15 minutes at tumble speeds above 25 rpm can reduce aqueous dissolution of the salt matrix, although mineral salts are freely soluble. Powder presentations are filled into sachets after passing through a 500 μm security sieve to remove agglomerates formed during storage at relative humidity above 60%. Granules are produced by wet granulation with purified water or isopropanol and dried at inlet air temperature not exceeding 60°C to avoid localized dehydration of hydrated calcium sulfate species. Oral premixes for medicated feed require a different particle-size and carrier strategy because the API is mixed into mineral or vitamin premixes at inclusion rates from 0.5 kg/ton to 20 kg/ton; uniform distribution is confirmed by assay of ten stratified samples per 1 t batch. For all oral solid presentations, package closure should maintain relative humidity below 45% to prevent caking; desiccant quantity is calculated from the moisture vapor transmission rate of the primary packaging material using ISO 15106-3.
For injectable solutions and sterile powders, AMS-VG-9 is specified with lower bioburden and particulate matter limits than the oral model. Bacterial endotoxin content is tested by Ph. Eur. 2.6.14 or USP <85> with a release limit assigned according to the maximum intended dose per kilogram of body weight. In water for injection-based formulations, the API must not contribute more than 0.25 EU/mg when the maximum single dose is 1 mg/kg; the exact limit is dosage-form dependent and is calculated under the principles of Ph. Eur. 5.1.1. Subvisible particulate matter is controlled by Ph. Eur. 2.9.19 or USP <788> after reconstitution; the API itself is not sterile, and terminal heat sterilization at 121°C for 15 minutes is feasible for aqueous solutions when pH remains below 7.5 to avoid precipitation of magnesium hydroxide. Filtration through 0.22 μm sterilizing-grade polyethersulfone is used before aseptic filling. The API is free of organic amines, chelating agents, and preservatives to avoid incompatibility with rubber closures and borosilicate glass. Aluminum content is controlled under Ph. Eur. 2.4.17 because elevated aluminum is a safety concern in parenteral electrolyte solutions. Injectable-grade material is also tested for arsenic, cadmium, lead, and mercury according to ICH Q3D; permitted daily exposure values for parenteral use are 15 μg/day arsenic, 2 μg/day cadmium, 5 μg/day lead, and 3 μg/day mercury. Published data for subvisible particulate stability in multidose rubber-stoppered vials are limited; compatibility with elastomer closures should be confirmed by extractables studies under USP <1663> and USP <1664>.
Solutions for oral drench or drinking water are manufactured from the oral-grade model by simple dissolution under high-shear mixing at 20°C to 25°C. Complete dissolution of a 10% w/v solution is expected within 10 minutes when impeller tip speed is at least 3 m/s. The solution is filtered through a 10 μm polypropylene depth filter to remove insoluble carbonate residues before filling. pH of a 5% w/v aqueous solution is controlled between 5.5 and 7.5 per Ph. Eur. 2.2.3. If the solution is intended for addition to drinking water lines, chlorine dioxide or hypochlorite disinfection is not recommended because hypochlorite oxidizes bromide and iodide if these trace anions are present in the specification. In oral rehydration solutions for calves and piglets, the API is combined with glucose or glycine; the glucose-containing mixture should be filled promptly after dissolution because reducing sugars can promote Maillard degradation of amino acid additives if present, though the inorganic salt matrix itself remains stable. Solution storage should avoid unprotected steel surfaces because chloride-containing formulations can initiate pitting corrosion in 316L stainless steel when pH falls below 4.0; passivated 316L or polypropylene equipment is preferred.
AMS-VG-7 and AMS-VG-9 differ from feed-grade inorganic premixes in three compendial control areas: elemental impurities, organic carrier absence, and powder uniformity. Feed-grade mineral premixes may contain coarse limestone, magnesium oxide, and clay-based carriers; these are not controlled as active ingredients and may contribute aluminum, arsenic, and silica. In contrast, the veterinary-grade API uses only purified chloride and sulfate salts and a defined cation ratio. The comparative matrix below summarizes the principal release differences.
| Control parameter | AMS-VG-7 oral | AMS-VG-9 injectable | Feed-grade mineral premix |
|---|---|---|---|
| Elemental impurities | ICH Q3D oral PDE: Pb 5 μg/day, Cd 2 μg/day, As 15 μg/day, Hg 30 μg/day | ICH Q3D parenteral PDE: Pb 5 μg/day, Cd 2 μg/day, As 15 μg/day, Hg 3 μg/day | Regional feed limits; not harmonized under ICH Q3D |
| Residual solvents | VICH GL18 class 1 and class 2 limits | VICH GL18 class 1 and class 2 limits | Not usually tested |
| Loss on drying | ≤ 1.0% by Ph. Eur. 2.2.32 | ≤ 0.5% by Ph. Eur. 2.2.32 | Variable; depends on carrier moisture |
| Particle size | D50 150 μm–250 μm by Ph. Eur. 2.9.3 | Not applicable for solution; solid API passes 500 μm sieve | Coarse, heterogeneous; may include particles >1000 μm |
| Microbial limits | TAMC ≤ 10³ CFU/g, TYMC ≤ 10² CFU/g by Ph. Eur. 2.6.12/2.6.13 | TAMC ≤ 10² CFU/g; no Escherichia coli by Ph. Eur. 2.6.13 | May exceed 10⁵ CFU/g; not used for sterile products |
The artificial mineral salt matrix also removes batch-to-batch geological variation present in mined salt sources. Natural salt sources may vary in sulfate-to-chloride ratio by more than 15% across mining zones, while AMS-VG-7 is blended to a defined cation ratio with tolerance of ±5% for each declared ion. In premix conversion, this defined ratio reduces the need for reformulation of calcium-to-phosphorus balance in compound feed; however, published data on production-scale cross-contamination in feed mills is limited and mill-specific carryover must be validated by worst-case cleaning studies. If the material is stored in unlined paper sacks above 70% relative humidity, calcium chloride species may deliquesce within 24 hours, causing caking and assay loss in the upper layer. The product should not be blended with strong oxidizing agents, and hypochlorite sanitizers should be eliminated from equipment surfaces before use.
AMS-VG-7 is offered in two stoichiometric variants: a chloride-dominant matrix for poultry and swine rehydration, and a sulfate-supplemented matrix for ruminant oral preparations where sulfur supply is relevant. The chloride-dominant variant contains sodium and potassium chloride as major components with calcium chloride not more than 5.0% of the anhydrous basis; the sulfate variant replaces a portion of the chloride with sodium sulfate so that the final sulfate-to-chloride molar ratio does not exceed 0.3. AMS-VG-9 is supplied only as the chloride-dominant matrix to avoid sulfate precipitation when mixed with calcium-containing infusion solutions. If a formulation requires a different ratio, the API is custom-blended to order under the same quality system, but the finished product must be re-validated for solubility and content uniformity. Published data on species-specific electrolyte uptake from artificial mineral salt API is limited; dose ratios should be derived from the target veterinary drug monograph or from national veterinary formularies.
The following compliance matrix is applied as a batch-release checklist for the major routes of administration.
| Application | Critical test | Standard designation | Endpoint |
|---|---|---|---|
| Tablets/capsules | Uniformity of dosage units | Ph. Eur. 2.9.40 / USP <905> | AV ≤ 15.0 |
| Tablets | Disintegration | Ph. Eur. 2.9.1 / USP <701> | ≤ 15 min uncoated |
| Injections | Bacterial endotoxins | Ph. Eur. 2.6.14 / USP <85> | Dose-based limit |
| Injections | Subvisible particulate matter | Ph. Eur. 2.9.19 / USP <788> | ≥ 10 μm: ≤ 6000 per container; ≥ 25 μm: ≤ 600 per container |
| Solutions | pH | Ph. Eur. 2.2.3 | 5.5–7.5 for 5% w/v solution |
| Premix | Uniformity of distribution | Assay of 10 stratified samples | RSD ≤ 5.0% |
The model-specific choice between AMS-VG-7 and AMS-VG-9 should be recorded in the formulation dossier and linked to the route of administration. For medicated feed premix, the oral grade is selected because the product is not intended for sterile application; for injectable electrolyte solutions, the parenteral grade is mandatory because the oral grade lacks endotoxin and subvisible particulate release tests. In all cases, the API is a starting material, not a final dosage form, and the finished product must be validated for stability under ICH Q1A(R2) and for container-closure suitability under USP <1663>/<1664> where elastomer contact is expected. Mixing equipment should be constructed from 316L stainless steel or polypropylene to avoid chloride-induced corrosion; rubber lining and unprotected carbon steel are not recommended for continuous use.
