| HS Code | 388637 |
| Product Name | Longdan Sodium Bicarbonate Veterinary Grade API |
| Api | Sodium Bicarbonate |
| Grade | Veterinary Grade |
| Chemical Formula | NaHCO3 |
| Cas Number | 144-55-8 |
| Molecular Weight | 84.01 g/mol |
| Appearance | White crystalline powder |
| Odor | Odorless |
| Solubility | Freely soluble in water; insoluble in ethanol |
| Ph 1 Aqueous Solution | 8.3 |
| Assay Dried Basis | 99.0% - 100.5% |
| Loss On Drying | ≤ 0.25% |
| Heavy Metals | ≤ 10 ppm |
| Chloride | ≤ 0.02% |
| Sulfate | ≤ 0.02% |
| Arsenic | ≤ 3 ppm |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Particle Size | Uniform powder suitable for direct compression and formulation |
As an accredited Longdan Sodium Bicarbonate Tablets 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 25kg multi-layer drums with inner polyethylene liners, clearly labeled for veterinary-grade API use. |
| Container Loading (20′ FCL) | One 20-foot FCL loaded with Longdan veterinary-grade sodium bicarbonate tablets API, securely palletized, protected, and documented for safe transport. |
| Shipping | Longdan Sodium Bicarbonate Tablets (Veterinary Grade API) ship securely in sealed, moisture-resistant drums or bags, with proper hazard labeling. Transport at ambient temperature, avoiding humidity and direct sunlight. Ensure compliant documentation for veterinary pharmaceutical use. Handle gently to prevent breakage, and store in a cool, dry warehouse during transit. |
| Storage | Store in a cool, dry, well-ventilated area away from direct sunlight and moisture. Keep containers tightly sealed to prevent caking or degradation. Avoid contact with acids and incompatible materials. Protect from excessive heat and humidity. Use clean, dry equipment when handling. Follow veterinary label guidelines; use within manufacturer’s stated shelf life. |
| Shelf Life | Shelf life is typically 24 months when stored in tightly sealed original containers, in a cool, dry place. |
Direct compression of sodium bicarbonate API into oral antacid boluses for adult ruminants places two competing constraints on the formulation: tablet hardness must exceed 150 N to survive rumen chewing and bolus gun delivery, while compression force above 18 kN initiates capping because the crystalline material exhibits limited compactibility. The API is milled to a particle size distribution with D90 below 150 µm and blended with 8–12% microcrystalline cellulose and 0.5% magnesium stearate in a bin blender at 12 rpm for 20 minutes; lubricant blending beyond 30 minutes reduces tablet hardness by 15–25% at the same main compression force. Tablets containing 10 g to 25 g sodium bicarbonate per unit are compressed on a rotary press with precompression stations set at 8–12 kN and main compression at 16–20 kN. The finished tablet is tested for friability per USP <1216>, with a limit of not more than 1.0% after 100 revolutions, and for dissolution per USP <711> using 0.1 M hydrochloric acid as the medium. The API must meet the USP sodium bicarbonate monograph, which specifies an assay of 99.5–100.5% on the dried basis and a loss on drying of not more than 0.25% at 105°C for 4 hours. Veterinary drug product manufacturing must operate under 21 CFR 211 cGMP, and the terminal 25 g tablet is administered orally to cattle with rumen atony or simple indigestion. In lactating dairy cattle, dietary sodium bicarbonate at 0.75–1.0% of total mixed ration dry matter buffers rumen fluid above pH 5.8 during subacute ruminal acidosis challenges; the bolus form is reserved for acute intervention when ration reformulation cannot be implemented immediately. The tablet dosage form must avoid contact with acidic granulation binders because premature CO2 release during wet granulation causes intra-tablet porosity and hardness loss.
Injectable sodium bicarbonate solutions intended for intravenous correction of metabolic acidosis in cattle, sheep, and companion animals are filled at a concentration of 8.4% w/v, equivalent to 1 mEq/mL bicarbonate. The dominant manufacturing risk is the reversible equilibrium between bicarbonate, carbonate, and dissolved carbon dioxide; terminal sterilization by steam at 121°C for 15 minutes shifts this equilibrium toward carbonate, increasing solution pH above the acceptable upper bound unless the headspace is saturated with carbon dioxide. Commercial fill lines therefore purge the headspace with carbon dioxide during vial filling and maintain a CO2 partial pressure of 0.5–1.0 bar prior to sealing. The finished injection must comply with USP <71> sterility testing, USP <85> bacterial endotoxin testing with a limit derived from the maximum labelled dose, and USP <788> particulate matter limits for injectable volumes above 100 mL. The USP Sodium Bicarbonate Injection monograph specifies a pH range of 7.0–8.5. Terminal sterilization autoclave cycles are validated to achieve an F0 value of 8–12 minutes; lower F0 values are permissible only when pre-filtration bioburden is below 10 CFU/100 mL. The API for injectable use must additionally be tested for bacterial endotoxins and particulate matter prior to release. Clinical use in cattle with metabolic acidosis may require doses of 2–5 mEq/kg body weight infused slowly; rapid infusion above 1 mEq/kg/min is associated with paradoxical cerebrospinal fluid acidosis and must be avoided. The terminal product is a sterile 500 mL or 1000 mL bag or vial supplied with a latex-free injection port, and the solution must not be mixed with calcium-containing infusions due to calcium carbonate precipitation.
Encapsulation of sodium bicarbonate API for equine gastric ulcer prophylaxis requires dry filling conditions because the crystalline powder is incompatible with free moisture and acidic excipients. Hard gelatin capsule shells with a moisture specification of 13.5–16.0% w/w are used, and the fill material is preconditioned at ≤45% RH and 20–25°C for at least 24 hours before filling. The API is passed through a 0.5 mm screen to break agglomerates and then filled on an intermittent-motion capsule filler using a dosator nozzle; fill weight variation for a 5 g capsule target is controlled to ±3%. The powder fill blend typically contains 90–95% sodium bicarbonate with 5–10% pregelatinized starch as a glidant. Lubricant addition is not used because magnesium stearate delays dissolution in gastric acid. Capsule products are tested for disintegration in 0.1 M hydrochloric acid at 37°C according to USP <701>, with a limit of not more than 15 minutes; dissolution testing under USP <711> uses 0.1 M HCl at 50 rpm. In exercising horses, oral sodium bicarbonate at 0.5–1.0 g/kg body weight is administered as a buffering agent; capsule strengths of 2 g to 10 g allow flexible dosing. Published comparative dissolution data for veterinary sodium bicarbonate capsules is limited; formulators rely on pharmacopeial disintegration and dissolution criteria to confirm batch consistency. The API for capsules must meet the same USP monograph limits, and the finished product must be manufactured under cGMP for veterinary products, with specific attention to cross-contamination control because the capsule line often processes other equine supplements. The terminal product is a two-piece hard gelatin capsule labelled for equine use, packed in high-density polyethylene bottles with desiccant canisters, and stored below 30°C and ≤45% RH to prevent shell softening and fill material caking.
Granulated sodium bicarbonate intended for inclusion in poultry and swine feed premixes is produced by dry roller compaction rather than aqueous granulation because contact with water initiates conversion to sodium carbonate and releases CO2, reducing available alkalinity. The compaction granulation step uses a roller compactor with a roll pressure of 120–180 bar and a gap width of 2–3 mm; the compacted flakes are milled to a target particle size distribution of 200–800 µm. The granulate is then mixed with a carrier such as ground limestone or wheat middlings in a horizontal ribbon blender operating at 60% fill volume for 4–6 minutes; batch homogeneity must achieve a coefficient of variation below 5% when analyzed for sodium content by atomic absorption spectroscopy at ten sampling points. In broiler heat-stress rations, sodium bicarbonate is included in complete feed at 0.2–0.5% by weight, often in combination with potassium chloride, to reduce respiratory alkalosis and maintain plasma bicarbonate during panting. The premix form is typically a 0.5–1.0% inclusion product, added to final feed at 10–25 kg per tonne. Compliance for the premix falls under EU Regulation (EC) No 183/2005 feed hygiene and Directive 2002/32/EC on undesirable substances; in the United States, sodium bicarbonate is listed as generally recognized as safe for animal feed use under 21 CFR 582.1736. The granulated premix must be stored in moisture-proof packaging at ≤30°C and ≤60% RH, because exposure to humidity above 60% RH causes caking and progressive loss of available bicarbonate. Premix formulation must avoid co-processing with citric acid or other acidulants in the same blend because premature CO2 generation can rupture packaging and reduce bicarbonate content before feeding. The terminal product is a free-flowing granulated premix packed in 25 kg multi-wall paper bags with polyethylene liners, intended for metered addition to complete feed at the feed mill.
Neonatal calf oral rehydration powders containing sodium bicarbonate as the alkalinizing component must balance bicarbonate concentration against total solution osmolarity, because reconstituted solutions exceeding 300 mOsm/L delay abomasal emptying and reduce voluntary intake in scouring calves. A veterinary oral rehydration sachet commonly contains 2.5–4.0 g sodium bicarbonate, 2.0–3.5 g sodium chloride, 1.5–2.5 g potassium chloride, and 15–20 g glucose per 2 L of water, producing an osmolarity in the range of 250–290 mOsm/L. The API is dry-mixed with the electrolytes in a V-blender for 15–20 minutes; the blend is then granulated by roller compaction at 100–150 bar to a particle size distribution of 150–500 µm to prevent segregation during sachet filling. Moisture content of the finished granules is controlled below 0.5% by Karl Fischer titration, because higher moisture promotes caking and reduces flow on high-speed vertical form-fill-seal machines. The finished sachet is filled with a fill weight variation of ±2%, and the sachet material is a four-layer laminate with a water vapor transmission rate below 0.5 g/m²/day at 38°C/90% RH. Compliance for the veterinary medicinal product is under EU Regulation 2019/6 and GMP requirements; the API must meet the USP or EP sodium bicarbonate monograph with an assay of 99.0–100.5%. The terminal product is a 20 g sachet that is dissolved in 2 L of warm water and administered orally to calves with acute diarrhea; treatment is limited to 24–48 hours unless electrolyte imbalances persist. Sodium bicarbonate-containing oral rehydration solutions must not be administered simultaneously with acidic oral medications, as the resulting effervescence can reduce palatability and cause regurgitation in weak calves.
Aqueous sodium bicarbonate solutions prepared from veterinary-grade API are used in fish transport tanks and hatchery holding systems to raise total alkalinity to 50–150 mg/L as CaCO3 and to buffer against pH depression caused by elevated dissolved CO2. The dose is calculated from water alkalinity deficiency: raising total alkalinity by 1 mg/L as CaCO3 requires 1.68 mg/L sodium bicarbonate. The solution is prepared as a 5% w/v stock solution and injected into recirculation lines using a peristaltic pump; the dosing rate must change water pH by no more than 0.5 units per hour to avoid shifting ammonia toward the more toxic un-ionized form. In transport tanks, a 50 g pre-weighed water-soluble unit pack added to 1000 L water provides an alkalinity increase of approximately 30 mg/L as CaCO3. Compliance for aquaculture water treatment falls under national water quality codes and FAO Technical Guidelines for Responsible Fish Transport; sodium bicarbonate used in food fish must meet food chemical specifications such as FCC or USP grade to avoid heavy metal contamination. The terminal product is a 50 g unit-dose water conditioner that is dissolved in a separate mixing vessel before distribution, and the solution must not be mixed with acidic sanitizers or alum-based flocculants because rapid CO2 release can reduce dissolved oxygen at the point of addition. Published data for bicarbonate addition rates in closed transport tanks under high fish loading densities is limited; dose calculations are based on alkalinity stoichiometry and alkalinity depletion measurements before transport.
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Pharmaceutical processing of sodium bicarbonate into veterinary dosage forms requires tighter control than commodity applications. The designation Longdan Sodium Bicarbonate Tablets Veterinary Grade API identifies the material as a multi-route active pharmaceutical ingredient rather than a finished product. It is supplied as a white crystalline powder with chemical formula NaHCO3, CAS 144-55-8, and relative molecular mass 84.01 g/mol. Release testing follows the current United States Pharmacopeia Sodium Bicarbonate monograph; the acceptance profile includes assay 99.0–100.5 % on the dried basis, chloride not more than 0.015 %, sulfate not more than 0.015 %, heavy metals not more than 5 ppm, iron not more than 20 ppm, and loss on drying not more than 0.25 %. The powder is not sterile and must be subjected to downstream sterilisation or filtration when used in injectable preparations.
Physical specification is not a single fixed value because the product is used across tablets, injections, capsules, powders, granules, premixes, and solutions. Batch-specific particle-size analysis is reported by laser diffraction according to ISO 13320:2020. Direct-compression grades are typically milled to a median particle size D50 between 80 µm and 150 µm, while material intended for solution manufacture may be supplied as coarse crystalline powder for rapid dissolution. Bulk density and tapped density are determined by USP <616> Method I and Method II. Formulation calculations should use the dried-basis assay because residual moisture affects both label claim and powder flow.
| Property | Acceptance criterion | Method / standard |
|---|---|---|
| Identification (sodium) | Positive | USP <191> |
| Assay on dried basis | 99.0–100.5 % | Acidimetric titration, USP <541> |
| Chloride | ≤ 0.015 % | USP <221> |
| Sulfate | ≤ 0.015 % | USP <221> |
| Heavy metals as Pb | ≤ 5 ppm | USP <231> |
| Iron | ≤ 20 ppm | USP <241> |
| Arsenic | ≤ 2 ppm | USP <211> |
| Loss on drying | ≤ 0.25 % | USP <731> |
| Particle size, direct-compression grade | D50 80–150 µm | Laser diffraction, ISO 13320:2020 |
| Bulk density | 0.85–1.10 g/cm³ | USP <616> Method I |
The chloride and sulfate limits are not arbitrary; they influence clarity, precipitation risk, and particulate formation during solution compounding. Heavy metal and iron limits become critical when the API is used in injectable or long-term oral products intended for food-producing species.
Injectable manufacturing from this API is governed primarily by CO2 equilibrium, endotoxin burden, and particulate load. A stock solution at 8.4 % w/v is hypertonic, containing approximately 1000 mEq/L bicarbonate and 1000 mEq/L sodium. The equilibrium HCO3− + H+ ⇌ H2CO3 ⇌ CO2 + H2O means that reduced headspace pressure, increased temperature, or reduced pH will shift dissolved CO2 into the gas phase. In 316L stainless steel compounding vessels this produces foaming and can reduce filter flux during passage through 0.22 µm sterilising-grade membrane cartridges. Aseptic filtration is preferred over terminal steam sterilisation because moist heat at 121 °C accelerates CO2 evolution and may generate container headspace pressure.
Finished injectable solutions must comply with USP <71> Sterility Tests, USP <85> Bacterial Endotoxins, USP <788> Particulate Matter in Injections, and USP <785> Osmolality. For large-volume parenterals, particulate limits are not more than 25 particles/mL at ≥10 µm and not more than 3 particles/mL at ≥25 µm as described in USP <788>. Endotoxin limits are product-specific; a common upper limit for intravenous infusion is 0.5 EU/mL, but the target species and dose volume determine the final limit. Because the raw API is nonsterile, sterility assurance is the responsibility of the finished dosage form manufacturer. The final solution pH is typically 7.0–8.5; excursions below 7.0 indicate excessive CO2 absorption or insufficient bicarbonate remaining. Mixing with calcium-containing intravenous fluids should be avoided unless calcium carbonate precipitation is evaluated by visual inspection and particle sizing.
Across tablet and capsule manufacturing lines, the controlling powder properties are flow, compressibility, and moisture. Direct compression of this API is feasible when the D50 remains within 80–150 µm and the compressibility index remains below 30 % as defined by USP <616>. Production-scale rotary presses with 45-station turrets have shown capping at API loadings above 40 % w/w when tablet hardness exceeds 12 kp and residual moisture is below 0.15 %. In such cases, dry binding with microcrystalline cellulose at 20–40 % w/w and lubrication with magnesium stearate at 0.5–1.0 % w/w are introduced. Lubrication blending time should not exceed 3–5 min to avoid excessive hydrophobic film formation and hardness reduction of 10–20 %. For capsule filling, powder flow can be improved with 0.1–0.5 % fumed silica. Wet granulation using aqueous binders is possible only when the granulation is performed under anhydrous conditions or when acid components are segregated; otherwise CO2 evolution creates porous granules and variable density. Effervescent tablets require physical separation of the API from the acid component during granulation and storage.
For oral powders, granules, and premixes, the homogeneity of the API in a carrier is the critical quality attribute. A dilution ratio of 1:10 to 1:100 with lactose monohydrate or dextrose is typical before further dilution into feed. Blend uniformity is evaluated by sampling 10 locations using a unit-dose thief; acceptance is 90–110 % label claim with relative standard deviation not more than 5 %, following the general approach of USP <905> for dosage unit uniformity.
In lactating dairy cows, sodium bicarbonate is used as a ruminal buffer at 0.75–1.0 % of dietary dry matter. For a cow consuming 25 kg dry matter per day, this corresponds to 150–225 g/day. The carbonate equilibrium buffers volatile fatty acids produced during high-concentrate feeding; field response is conditional on forage particle size, feeding frequency, and transition-cow management. In poultry heat-stress rations, sodium bicarbonate inclusion levels of 0.1–0.5 % complete feed have been reported to support acid-base balance, but published data for this specific configuration is limited and the level must be adjusted to dietary electrolyte balance and water intake.
Granule processing should avoid aqueous granulation when the API is combined with acidifiers. Dry granulation by roller compaction at roll pressure 30–70 bar and milling to 20–40 mesh is preferred. If fluidised-bed granulation is used, inlet air temperature should not exceed 50 °C and final granule moisture should be controlled between 0.1 % and 0.3 % to avoid caking during storage. Feed-use status is supported by FDA 21 CFR 184.1736; however, finished medicated feed must additionally comply with local veterinary prescription requirements.
Dissolution of sodium bicarbonate in purified water is endothermic; stock solutions for oral administration are typically prepared at 1–5 % w/v. To produce a 5 % w/v solution, 50 g of API is dissolved in 1000 mL of water at 20–25 °C with mixing; the resulting solution contains approximately 595 mEq/L bicarbonate and 595 mEq/L sodium. For oral drench administration in calves and lambs, dose is calculated from acid-base deficit: bicarbonate dose in mEq = 0.3 × body mass (kg) × base deficit (mEq/L). Solutions must be packaged in closed containers with minimal headspace because atmospheric CO2 absorption changes pH; storage time after opening should not exceed 24 h unless stability data support longer holding. The solution should not be mixed with citric acid, ascorbic acid, or other acidic vehicles because effervescence and pH drift may reduce dosing accuracy.
Differentiation from reagent-grade and feed-grade sodium bicarbonate is measurable at the specification level. Reagent-grade material may carry an assay of 99.7 % or higher but is not supplied with particle-size data optimised for direct compression, and it is not released with endotoxin or GMP documentation for veterinary drug manufacturing. Feed-grade sodium bicarbonate may contain sulfate and chloride at levels that do not affect ruminal buffering but can form precipitates or exceed quality limits in injectable compounding. The veterinary-grade API is therefore neither the purest nor the cheapest grade; it is specificationally matched to pharmaceutical unit operations. Batch-to-batch variance of the API should be monitored by tracking D50, loss on drying, and chloride, because these three parameters predict most downstream tableting and solution-clarity failures.
Operational boundaries are explicit. The product should be stored in tightly closed containers at controlled room temperature and protected from humidity. At relative humidity above 60 %, sieving or drying at 40–50 °C is recommended before direct compression. The material is incompatible with strong acids, acidic salts, and calcium-containing solutions unless precipitation risk is assessed. It should not be exposed to open air for extended periods because CO2 exchange can alter surface carbonate equilibrium and flow. These boundaries are process controls, not safety limits; sodium bicarbonate is not classified as hazardous under GHS but can generate CO2 upon contact with acids.
