| HS Code | 311857 |
| Chemical Name | Tartaric Acid |
| Molecular Formula | C4H6O6 |
| Cas Number | 87-69-4 |
| Appearance | White crystalline powder or colorless crystals |
| Solubility | Freely soluble in water; slightly soluble in ethanol; practically insoluble in chloroform and ether |
| Melting Point | 168-172 °C |
| Specific Optical Rotation | +11.5° to +13.5° (for L-(+)-tartaric acid, 20% w/v in water) |
| Assay Dry Basis | 99.5% to 100.5% |
| Ph 5 W V Aqueous Solution | 1.6 to 2.4 |
| Microbial Purity | Complies with pharmacopoeial limits for absence of objectionable microorganisms |
As an accredited Tartaric Acid 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 | Packaging: 25 kg net in double-lined, tamper-evident drums, protecting Tartaric Acid Veterinary Grade API for stable formulation across multiple dosage forms. |
| Container Loading (20′ FCL) | Container Loading (20′ FCL): Tartaric Acid Veterinary Grade API is loaded into one 20-foot container, in sealed, palletized drums, secured for safe transport. |
| Shipping | Tartaric Acid Veterinary Grade API is shipped in sealed, moisture-resistant drums or bags on palletized loads. Transport is performed in clean, dry, temperature-controlled containers to preserve purity. Documentation includes Certificate of Analysis and safety data sheets, ensuring compliance with veterinary pharmaceutical regulations and safe handling throughout transit. |
| Storage | Store Tartaric Acid Veterinary Grade API in a cool, dry, well-ventilated area, away from direct sunlight, heat, and moisture. Keep containers tightly closed when not in use to prevent caking or degradation. Avoid contact with strong oxidizers and alkaline substances. Maintain room temperature and protect from physical damage. |
| Shelf Life | Shelf life is typically 36 months when stored in a tightly closed container, protected from light and moisture. |
Under controlled relative humidity below 30%, tartaric acid veterinary grade anhydrous is introduced into direct-compression effervescent tablet batches used for companion-animal oral acidification. The acid-carbonate reaction requires 1.12 g sodium bicarbonate per 1.00 g tartaric acid on a 1:2 molar basis; manufacturing batches commonly retain 10–15% excess acid by weight to ensure effervescence ceases only after the tablet core is fully disintegrated, leaving a solution pH between 3.8 and 4.2. Formulation mass includes tartaric acid at 15–30% w/w of total core weight, adjusted according to the co-administered API’s acid liability. Direct compression is performed on an eccentric tablet press equipped with 10 mm flat-faced beveled punches at a main compression force of 8–18 kN; aqueous granulation is avoided because free water initiates premature carbon dioxide release. In-process tablet hardness is maintained at 40–80 N, and friability is controlled to ≤0.8% according to USP 1216. Raw tartaric acid is dried in a vacuum tray dryer at 40 °C for 4 h to a loss-on-drying endpoint of ≤0.4% w/w. Blending is performed in a bin blender at 25 rpm for 20 min with 1.0% w/w sodium stearyl fumarate as lubricant to avoid insoluble film residue associated with magnesium stearate in effervescent solutions. Final dosage units are tested for weight variation by USP 905 and disintegration by USP 701; batch release follows 21 CFR 211 for finished veterinary pharmaceuticals. Terminal products are 500 mg and 1 g veterinary effervescent tablets for dogs and cats, with labeling that specifies dissolution in 50–100 mL potable water before administration.
Parenteral aqueous systems containing tartaric acid as a buffer acid are designed around the dicarboxylic acid’s two dissociation constants, pKa₁ = 2.98 and pKa₂ = 4.34, which impart maximum buffer capacity between pH 2.8 and 5.4. For large-animal injectable vehicles, a 0.02–0.05 M tartrate buffer is prepared by dissolving 0.30–0.75% w/v tartaric acid in Water for Injection and partially neutralizing with 1 M sodium hydroxide to a target pH of 3.8–4.2. The solution is filtered through a 0.22 µm PVDF membrane and filled into 100 mL Type I borosilicate glass vials, then terminally sterilized at 121 °C for 15 min with an F₀ ≥ 8. Particulate matter is verified by USP 788: for a large-volume parenteral, counts must not exceed 25 particles/mL at ≥10 µm and 3 particles/mL at ≥25 µm. Bacterial endotoxin testing follows USP 85. The critical operational boundary is divalent-cation incompatibility: calcium and magnesium ions present in hard water or leached from container elastomers precipitate sparingly soluble tartrate salts, creating visible particulates; therefore rubber stoppers must be siliconized and prewashed with WFI, and calcium-containing diluents are avoided. VICH stability batches are stored at 25 °C/60% RH and 40 °C/75% RH per VICH GL1. The terminal products are sterile aqueous vehicles used to reconstitute lyophilized veterinary antibiotics or to buffer pH-sensitive injectable actives in cattle and equine patients; published data for tartaric acid as a sole injectable active ingredient is limited, so its role is restricted to functional buffer-excipient status.
In hard capsule manufacturing for companion-animal acidifier products, tartaric acid crystalline needles with an aspect ratio above 5:1 create bridge formation in dosator nozzles on automatic capsule fillers, causing fill weight RSD values greater than 3.5%. To mitigate this, the acid is co-milled with lactose or microcrystalline cellulose in a cone mill fitted with a 0.5 mm screen, reducing particle agglomerates and improving flow. Tartaric acid is then incorporated at 15–30% w/w of the fill mass as a microclimate acidulant; this proportion depresses the surface pH of weakly basic APIs below 4.0 during dissolution, but published in vitro dissolution data for specific veterinary APIs in tartaric acid matrices are limited, so the ratio must be confirmed by USP 711 testing. Blending is performed in a tumble blender at 25 rpm for 20 min with 1% w/w fumed silica, followed by filling on a dosator-type capsule machine at 50,000 capsules/h. Capsule shells are preconditioned at 40–50% RH to prevent brittleness, and desiccant packets are included because tartaric acid anhydrous migrates moisture into gelatin shells at ambient humidity above 60%, potentially increasing cross-linking. Uniformity of dosage units is evaluated by USP 905 and disintegration by Ph. Eur. 2.9.1. Terminal products are hard gelatin or HPMC capsules containing 250 mg to 1 g tartaric acid, intended for dogs, cats, and small equine patients; fill volume is adjusted based on acid particle density rather than a fixed mass-to-volume factor.
Water medication lines in poultry and swine houses require acidification to depress pH below 4.5, a threshold below which Gram-negative pathogens such as Escherichia coli and Salmonella spp. exhibit reduced replication in drinking water. Tartaric acid veterinary grade is dissolved as a 5–10% w/v stock solution in a dosing tank and metered through a proportional injector calibrated to a 1:100 ratio, yielding final drinking water concentrations of 0.1–0.3% w/v depending on incoming alkalinity. For source water at 250 mg/L CaCO₃ alkalinity and pH 8.0, a starting dose of 2.5 kg tartaric acid per 1000 L is typically required to reach pH 4.0; field calibration at the end of the drinker line is required because mineral scales and biofilm buffer the system. The low pH accelerates corrosion of copper and galvanized drinker fittings, so stainless steel 304 or 316L lines are recommended, and weekly flushing with 50 ppm hydrogen peroxide is used to control biofilm. Compliance for non-medicated acidifier powders falls under general feed hygiene obligations in Regulation (EC) No 183/2003; if the powder is incorporated into a medicated water product, the formulation must meet Directive 2001/82/EC or its successor Regulation (EU) 2019/6. Terminal products are 500 g, 1 kg, and 5 kg water-soluble sachets in polyethylene-lined foil pouches, designed for dilution in poultry and swine drinker systems.
Dry granulation of tartaric acid with microcrystalline cellulose and povidone is used for oral acidifying granules administered to pre-ruminant calves because direct powder blends segregate in sachet filling lines and produce dust exposure. A roller compactor operating at 30–40 kN/cm roll force converts the blend into ribbons that are milled through a 1.0 mm screen to produce granules with a particle-size envelope of 150–800 µm, which reduces blend segregation and improves flow through a volumetric auger filler. Tartaric acid is included at 5–15% w/w of granule mass, with the lower boundary dictated by the need to acidify the oral cavity and degrade the protective matrix of ingested Gram-negative organisms in the abomasum of milk-fed calves. Granule moisture is controlled to ≤0.5% w/w after drying, and the magnesium stearate lubricant fraction is kept below 0.5% w/w to avoid prolonged dissolution of the acid layer. Segregation is monitored by sieve analysis according to USP 786, and finished granule uniformity is assessed by USP 905 if the granule is presented as a dosage unit. Compliance with 21 CFR 211 applies for medicated granules, while Ph. Eur. 5.1.4 governs microbiological quality of non-sterile oral products. Terminal products include 25 g foil-laminate sachets of acidifying granules for mixing into calf milk replacer or direct oral drenching; published data for tartaric acid-specific performance in calf enteric disease is limited, so dosing must be validated through farm-based pH monitoring.
Premix manufacturing for swine feed introduces tartaric acid as a granular acidulant to lower gastric pH in weanling piglets and to suppress Gram-negative bacterial proliferation in the feed matrix. Inclusion levels in creep and starter feeds are typically 0.3–0.6% w/w of complete feed, equivalent to 3–6 kg per 1000 kg feed; however, published data for tartaric acid-specific zootechnical effects are thinner than for citric or fumaric acid, and so the upper bound is not recommended unless farm-specific pH data justify it. The acid is blended into a carrier such as wheat middlings or limestone in a horizontal ribbon mixer at 25 rpm for 8–12 min until a tracer coefficient of variation ≤ 10% is achieved. Because tartaric acid is hygroscopic, the mixer room is held at 45–50% RH, and contact with aluminum equipment is avoided due to acid corrosion. Final premix bags are 25 kg multi-wall paper with polyethylene liners, sealed under nitrogen to prevent caking. If the premix contains a medicated article, batch release follows 21 CFR 558 for medicated feed applications; in the EU, the incorporation of tartaric acid as a feed material or additive requires verification against Regulation (EC) No 1831/2003 and Directive 2002/32/EC for undesirable substances. Terminal product is a free-flowing acidified premix intended for in-feed mixing by commercial feed mills producing piglet and broiler rations.
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Tartaric Acid Veterinary Grade API is supplied as L-(+)-2,3-dihydroxybutanedioic acid, CAS 87-69-4, EINECS 201-766-0, with a crystalline habit controlled for low dusting and particle-size consistency. The veterinary API designation is aligned with Ph. Eur. monograph 0470 and, where required, USP-NF compendial requirements; batch documentation may be coded as TAV-Ph. Eur.-VET to separate it from food-additive and technical lots. The dried-basis assay is held at 99.5–101.0%, with specific optical rotation of +12.0° to +12.8° at 20 °C. The product is intended for use as an acidifying active ingredient or pH-modifying excipient in tablet matrices, hard gelatin capsule fills, injectable solutions after endotoxin control, oral powders, granules, drinking-water premixes, and solution concentrates. Differences from other tartaric acid products are material at the batch-release level: food-additive material is not routinely screened for bacterial endotoxins, residual solvent classes under VICH GL18, or particle-size distribution; technical material may carry chloride, sulfate, calcium, oxalate, and heavy metal burdens that are unacceptable in oral or parenteral veterinary medicines.
Direct transfer is limited by bacterial endotoxin load, insoluble particulate matter, and sterile-filtration behaviour. Injectable-grade tartaric acid is released with a bacterial endotoxin limit derived from the maximum intended dose; for a parenteral vehicle administered at 1 mL/kg body weight and a threshold pyrogenic dose of 5 EU/kg, an API endotoxin limit of < 0.5 EU/mg measured by Ph. Eur. 2.6.14 is typical but must be justified lot-by-lot. Solutions prepared at 2–4% w/v have a pH near 2.1; terminal sterilization at 121 °C for 15 min in a load-probed autoclave is generally feasible because the dry compound shows a melt transition at 168–170 °C and is not volatile. The main aqueous processing risk is not thermal degradation but precipitation of calcium tartrate when hard water or calcium-containing excipients are present. Sterile filtration is typically performed through 0.22 µm polyethersulfone membrane filters qualified for bacterial retention per ASTM F838-20, after a clarifying 0.45 µm prefilter; post-filtration integrity testing uses bubble point or diffusion flow data. Endotoxin control is not a property of the molecule; it is a property of water quality, equipment cleaning, and controlled crystallization. A tablet-grade lot with low endotoxin release cannot be retroactively qualified for injection without data on bioburden reduction, filter compatibility, and final dose justification.
Tablet and capsule applications use tartaric acid primarily as a pH modifier, acidulant, and weak acid buffer rather than as a diluent; typical oral solid inclusion levels are 0.5–5.0% w/w. Direct compression runs on rotary tablet presses require a granular particle-size cut with D90 below 500 µm by laser diffraction according to ISO 13320 to limit dusting, punch sticking, and weight variation. High-shear wet granulation in a 10 L mixer shows that the acid should be dissolved in the granulating fluid rather than added as dry crystals when the formulation contains calcium carbonate or alkalizing agents. Granule drying is controlled to a residual moisture below 3.0% by rapid moisture balance, and fluid-bed inlet air temperature is kept at 45–55 °C because the freely soluble acid can migrate to the granule surface during high evaporation rates and create a crystalline film that retards tablet disintegration. For hard gelatin capsule fills, low-dusting granular material with D90 below 500 µm and tapped density above 0.8 g/cm³ by USP 616 assists consistent dosator filling. Tartaric acid should not be dry-blended with alkali metal carbonates unless effervescence is desired; calcium tartrate precipitation in aqueous film-coating or granulating fluids is an operational boundary. Published stability data for each multi-species oral formulation may be limited; compatibility testing under elevated stress conditions is required before batch scale-up.
Oral powders, granules, and milk-replacer or drinking-water premixes require low dusting, acceptable flow, and blend uniformity at low inclusion rates. A typical premix carry rate for tartaric acid is 0.5–5.0% w/w on dextrose, lactose, or sodium chloride carrier; a carrier matching D50 in the 200–400 µm range reduces segregation during transfer. Ribbon-blender or tumble-mixer blending is performed below 30 °C because static charging of fine tartaric acid particles causes wall adhesion and assay drift during subsequent sachet filling. Stock solutions for drinking-water administration are prepared at up to 10% w/v in stainless steel or polyethylene tanks; if feed-water alkalinity exceeds 200 mg/L as CaCO₃, the solution may become hazy from calcium tartrate formation, so a compatible hardness-control agent is required. The powder grade should be milled under controlled humidity and closed-container conditions; storage above 70% RH may cause caking even without chemical decomposition because of surface moisture adsorption and partial re-dissolution at crystal contact points. These processing limits distinguish the veterinary API from coarse food-grade crystals that are supplied without particle-size documentation and are not validated for low-dust and controlled-release premix operations.
Tartaric acid differs from citric, malic, and fumaric acids in pKa, aqueous solubility, and calcium-chelation behaviour. Tartaric acid has pKa₁ 2.98 and pKa₂ 4.34 at 25 °C, and its aqueous solubility of approximately 1330 g/L is the highest of the common acidulants. This produces a strong buffer window near pH 2.8–4.3 and allows concentrated stock solutions for drinking-water administration without heating. Citric acid is the most commonly substituted acidulant but has pKa₁ 3.13 and pKa₂ 4.76, with solubility near 592 g/L; malic acid is weaker with pKa₁ 3.40 and pKa₂ 5.11, and solubility near 558 g/L. Fumaric acid has a similar pKa₁ 3.03 and pKa₂ 4.44 but an aqueous solubility below 10 g/L, excluding it from injectable and most drinking-water solution applications. The comparative profile is summarised below; selection in veterinary formulation is driven by the target pH, available solubility, and compatibility with calcium-containing feeds or excipients.
| Acidulant | pKa₁ at 25 °C | pKa₂ at 25 °C | Water solubility at 25 °C (g/L) | Primary formulation implication |
|---|---|---|---|---|
| L-(+)-tartaric acid | 2.98 | 4.34 | 1330 | Concentrated solutions, strong calcium chelation, parenteral pH adjustment |
| Citric acid | 3.13 | 4.76 | 592 | High buffer capacity, hygroscopic oral solids |
| Malic acid | 3.40 | 5.11 | 558 | Milder acid, lower solubility |
| Fumaric acid | 3.03 | 4.44 | < 10 | Low solubility, limited use in solutions |
Manufacturing-source differences influence impurity profile. Tartaric acid can be obtained from wine lees or from maleic anhydride-derived synthesis; lees-derived material may contain potassium bitartrate residues, ethanol, and trace polyphenols, while synthetic routes can leave maleic acid or fumaric acid as processing markers. Veterinary-grade material is crystallized and dried under GMP; the certificate of analysis should disclose the source category and control oxalic acid, fumaric acid, and maleic acid as processing-related impurities. Published data for source-related impurity profiles may be limited; a robust specification therefore relies on the full compendial tests rather than source description alone.
Food-additive tartaric acid can satisfy acidity and purity limits under Commission Regulation (EU) 231/2012 without being released against ICH/VICH residual solvent classes, bacterial endotoxin requirements, or the same elemental impurities framework. Veterinary API lots are evaluated for Class 1, Class 2, and Class 3 residual solvents under VICH GL18; analysis is performed by headspace gas chromatography according to Ph. Eur. 2.4.24. If crystallization or washing involves ethanol, ethyl acetate, or isopropanol, the certificate of analysis should report Class 3 solvents below 5000 ppm or within the 50 mg/day permitted daily exposure, whichever is lower, and absence of Class 1 solvents such as benzene or carbon tetrachloride. Elemental impurity risk is assessed using ICH Q3D principles, with particular attention to arsenic, cadmium, lead, and mercury because tartaric acid sourced from wine lees or synthetic routes can concentrate trace metals. Heavy metals as lead are conventionally limited to 10 ppm; for injectable use, the elemental impurity burden is evaluated by summation across all excipients and active ingredients in the final dose. These controls are absent in many food-additive and technical-grade specifications; the difference is not primarily acid strength but the depth of certificate documentation and the ability to defend the material in a regulatory submission.
| Parameter | Method/Standard | Acceptance criterion |
|---|---|---|
| Appearance | Ph. Eur. 0470 | white or almost white crystalline powder |
| Assay, dried basis | Ph. Eur. 0470 | 99.5–101.0% |
| Specific optical rotation | Ph. Eur. 0470 | +12.0° to +12.8° at 20 °C |
| Loss on drying | Ph. Eur. 0470 | ≤ 0.5% |
| Sulfated ash | Ph. Eur. 0470 | ≤ 0.1% |
| Oxalic acid | Ph. Eur. 0470 | ≤ 350 ppm |
| Chloride | Ph. Eur. 0470 | ≤ 100 ppm |
| Sulfate | Ph. Eur. 0470 | ≤ 150 ppm |
| Calcium | Ph. Eur. 0470 | ≤ 200 ppm |
| Heavy metals as Pb | Ph. Eur. 2.4.8 | ≤ 10 ppm |
| Particle size D90 | ISO 13320 laser diffraction | ≤ 500 µm for direct-compression granular grade |
| Bacterial endotoxins, injectable grade | Ph. Eur. 2.6.14 | dose-dependent, commonly < 0.5 EU/mg |
| Residual solvents | VICH GL18 / Ph. Eur. 2.4.24 | Class 3 < 5000 ppm or 50 mg/day; Class 1 absent |
Technical-grade tartaric acid used in metal passivation, construction, or wine services is not interchangeable with veterinary API; its oxalic acid, chloride, iron, and heavy metal burdens are controlled for industrial functionality rather than oral or parenteral safety. A veterinary-grade certificate should show oxalate below 350 mg/kg, chloride below 100 mg/kg, sulfate below 150 mg/kg, calcium below 200 mg/kg, and heavy metals as lead below 10 mg/kg. Particle-size distribution, optical rotation, pH of a 1% w/v solution, loss on drying, and sulfated ash are also reported. The product is stored in closed containers below 70% RH and below 40 °C; it should be kept away from strong oxidizing agents, alkalizing agents, and calcium-containing water if precipitate-free solutions are required. For individual target-species palatability or pharmacokinetic performance, published data may be limited; formulation decisions should be supported by pH-solubility measurements and stability-indicating data rather than by extrapolation from human medicine.
