| HS Code | 201455 |
| Product Name | Sodium Dimercaptopropane Sulfonate Veterinary Grade API |
| Synonyms | DMPS; Sodium 2,3-dimercaptopropane-1-sulfonate; Unithiol |
| Molecular Formula | C3H7NaO3S3 |
| Molecular Weight | 210.27 g/mol |
| Cas Number | 4076-02-2 |
| Appearance | White or almost white crystalline powder with a slight characteristic mercaptan-like odor |
| Solubility | Freely soluble in water; sparingly soluble in ethanol; practically insoluble in ether and chloroform |
| Assay | ≥ 98.0% on dried basis |
| Loss On Drying | ≤ 1.0% w/w |
| Heavy Metals Limit | ≤ 10 ppm |
| Sulfhydryl Group Content | Contains active –SH groups capable of chelating heavy metals |
| Pharmacological Class | Thiol-containing heavy metal chelating agent |
| Suitable Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Condition | Store in air-tight containers, protected from light and moisture, in a cool, dry place |
| Veterinary Indication Type | For use in heavy metal poisoning detoxification in veterinary medicine |
As an accredited Sodium Dimercaptopropane Sulfonate 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 | Supplied as 25 kg net in sealed double polyethylene bags inside fiber drums, labeled for veterinary use. |
| Container Loading (20′ FCL) | 20′ FCL: drummed or bagged API palletized, secured, sealed in ventilated 20-foot container, protected from moisture, heat, and contamination. |
| Shipping | Sodium Dimercaptopropane Sulfonate (Veterinary Grade API) ships in sealed, moisture-proof containers, protected from light and heat. Requires stable ambient temperature, ventilation, and secure labeling as a chemical. Standard air, sea, or ground freight with proper documentation and hazard-compliant packaging ensures product integrity during transit. |
| Storage | Store in tightly sealed, original containers in a cool, dry, well-ventilated area at controlled room temperature, protected from light, moisture, and oxygen. Avoid exposure to heat, direct sunlight, and strong oxidizing agents. Ensure area remains clean and free from contamination. Proper storage preserves the API’s stability, potency, and suitability for veterinary formulations. |
| Shelf Life | Shelf life is typically 24–36 months when stored sealed, protected from light, at controlled room temperature. |
In acute small-animal heavy metal toxicosis, sodium dimercaptopropane sulfonate functions as a water-soluble dithiol chelator whose sulfhydryl groups bind ionic mercury, arsenic, and lead species to form renally cleared complexes. The sterile injectable dosage form is typically formulated as a 5.0% w/v solution, equivalent to 50 mg/mL, and filled into 10 mL or 30 mL amber borosilicate vials. Dissolved oxygen in the water for injection is reduced by nitrogen sparging to <0.1 mg/L before API dissolution because free thiol oxidation at ambient oxygen levels accelerates disulfide dimer formation and produces visible opalescence. pH is adjusted with 0.1 N sodium hydroxide to 6.0–6.8, and the bulk solution is filtered through a 0.22 µm PVDF membrane rather than autoclaved, since terminal heat sterilisation can increase colour intensity and reduce assay after 121 °C exposure. Aseptic filling is conducted in an ISO 5 unidirectional airflow zone within an ISO 7 cleanroom, and the finished product is controlled according to 21 CFR 211.94 for container closure integrity, 21 CFR 211.165 for final release, USP <85> for bacterial endotoxins, USP <788> for subvisible particulate matter, and VICH GL18(R2) for residual solvent limits. The terminal product types are single-dose vials for intravenous or intramuscular administration, with single-dose presentation preferred because preservative systems containing benzyl alcohol can interact with thiol groups and reduce available chelating capacity. Production equipment is glass-lined or constructed from 316L stainless steel after passivation; prolonged contact with copper or brass fittings is avoided because trace metal extraction from contact surfaces can deplete the API before filling.
Oral tablets and hard gelatin capsules containing sodium dimercaptopropane sulfonate are manufactured using direct compression or dry granulation rather than aqueous wet granulation, because exposure of the dithiol moiety to water and ambient air during binder addition lowers free sulfhydryl titre and increases related disulfide content. The API addition ratio in a direct compression dry blend is commonly 10–30 wt%, with final tablet mass between 150 mg and 500 mg and capsule fill weight between 200 mg and 600 mg. Typical unit strengths include 25 mg, 50 mg, 100 mg, and 250 mg of sodium dimercaptopropane sulfonate per tablet or capsule. Blending is performed in a V-blender or bin blender at 12–20 rpm for 10–15 min, and blend uniformity is evaluated according to USP <905> with an acceptance value not more than 15.0. Final blend moisture is maintained at ≤1.0% by Karl Fischer titration under USP <921>, and compression is executed on a rotary tablet press at 8–12 kN average main compression force to produce tablets with hardness between 40 N and 80 N. Dissolution testing follows USP <711> using 0.1 N hydrochloric acid or water as the medium; delayed release is not typical for this API unless an enteric coating is specifically requested. Component release and retesting follow 21 CFR 211.84, and elemental impurity controls are aligned with ICH Q3D or the corresponding VICH guidance because the raw material synthesis may carry palladium or other heavy metal residues. The terminal product types are immediate-release tablets and hard gelatin capsules for companion animal outpatient treatment, with desiccant-sealed packaging providing protection from humidity above 60% RH. Published stability data for veterinary-specific oral dose forms remain limited in some jurisdictions, but oxidative degradation is the primary confirmed failure pathway.
For group administration in poultry and swine, sodium dimercaptopropane sulfonate is formulated as a water-soluble powder or small-particle granulate intended for reconstitution into drinking water at stock concentrations of 0.1–1.0 g/L. The dry powder blend incorporates 1.0–10.0 wt% API, with anhydrous dextrose or maltodextrin selected over lactose when reducing sugar reactivity is a concern, and the blend is processed in a double-cone blender at 12–18 rpm for 20 min under controlled room conditions of ≤25 °C and ≤40% RH. In-process powder flow is monitored by USP <1174>, and moisture is limited to ≤0.5% by USP <921> because free water accelerates thiol oxidation during storage. The compounded powder is filled into foil-lined high-density polyethylene sachets of 5 g and 20 g or into bulk drums with nitrogen flushing, and the manufacturing batch is tested under 21 CFR 211.110 for fill weight variability and blend homogeneity. During reconstitution, the powder must be added to water at 20–25 °C and stirred for 2–5 min using a stainless steel or plastic stirrer; stock solutions are consumed within 24 h unless oxidative stability data support a longer in-use period. The terminal product types are water-soluble powder sachets, bulk powder for metering pumps, and oral solution prepared at the farm level. Drinking-water systems should not use copper piping for stock solution transfer because the dithiol chelator complexes copper and reduces both API activity and metal fixtures over prolonged exposure.
| Dosage form | API addition range | Critical process parameter | Release or control standard |
|---|---|---|---|
| Sterile injectable solution | 5.0% w/v | dissolved oxygen <0.1 mg/L, pH 6.0–6.8 | USP <788>, USP <85> |
| Oral tablet or capsule | 10–30 wt% in dry blend | blend moisture ≤1.0%, compression force 8–12 kN | USP <905>, USP <711> |
| Water-soluble powder | 1.0–10.0 wt% | ambient humidity ≤40% RH, blend time 20 min | USP <921>, USP <1174> |
| Medicated premix | 0.5–2.0 wt% in Type A premix | roll pressure 2–4 MPa, finished feed dilution 5–25 g per metric ton | 21 CFR 225.30, Regulation (EU) 2019/4 |
| Compounded oral capsule | 10–30 wt% trituration | beyond-use date 14 days | USP <795> |
In feed-based chelation programs for cattle and small ruminants, sodium dimercaptopropane sulfonate is incorporated into a Type A medicated article at 0.5–2.0 wt% of the premix, then diluted into finished feed at 5–25 g per metric ton only under a veterinary prescription or national equivalent regulatory framework. The production sequence begins with roller compaction of the API with microcrystalline cellulose and a dry binder at 2–4 MPa roll pressure, followed by milling through a 0.8 mm sieve and ribbon blending for 10–15 min. This dry granulation route avoids the open aqueous wet-massing step that would otherwise expose the sulfhydryl groups to oxidative loss and create a sticky bridge material on dryer surfaces. The medicated feed manufacturing line is cleared by flushing with an inert carrier such as ground limestone because residual dithiol API on product-contact surfaces can complex with stainless steel ions and produce a colour shift in subsequent batches. Compliance controls include 21 CFR 225.30 for equipment cleanout procedures, 21 CFR 226.58 for Type A medicated article inventory and packaging, Regulation (EU) 2019/4 for medicated feed production and distribution, and Directive 2002/32/EC for undesirable heavy metal limits in animal feed. The terminal product types are Type A medicated articles, Type B medicated feed concentrates, pelleted Type C complete feed, and mineral mix supplements. Published data for exact sodium dimercaptopropane sulfonate addition rates in food-producing animal feed remain limited, and residue depletion data must be generated under the intended species and production class before extralabel feed use is considered.
Veterinary compounding pharmacies receiving bulk sodium dimercaptopropane sulfonate for individual animal prescriptions prepare triturations by geometric dilution using lactose monohydrate, with the API ratio set at 10–30 wt% of the total powder mass and final capsule strengths of 25 mg, 50 mg, or 100 mg per unit. Compounding is performed in a glass mortar and pestle or a pharmacy-grade tumbler rather than automated high-shear mixers because the dithiol material softens under frictional heating and adheres to acrylic surfaces. The powder is filled into #3 or #4 hard gelatin capsules using a semi-automatic capsule filler, and each batch is checked for weight variation according to USP <795> compounding standards. Because the bulk API is hygroscopic when exposed to ambient air above 60% RH, all operations are conducted in a low-humidity enclosure or with an immediately available desiccant tray, and the final capsules are packaged in amber glass vials with silica gel desiccant. The assigned beyond-use date should not exceed 14 days unless formulation-specific stability data support a longer interval, and patients should be counselled to store the product at 20–25 °C in a dry environment. The terminal product types are compounded capsules, oral powder doses, and occasionally oral suspensions prepared with a suspending vehicle that does not contain oxidising preservatives. Equipment cleaning between batches requires 2% sodium bicarbonate solution followed by purified water because the thiol residue is more readily removed under mildly alkaline conditions than by organic solvents alone.
In avian and wildlife rehabilitation settings, dilute sodium dimercaptopropane sulfonate solutions for lead-exposed raptors and waterfowl are prepared from a 5.0% w/v injectable stock, with formulation addition in the final diluted solution reduced to 0.5–1.0% w/v using sterile isotonic diluent. The dilution is performed in an ISO 7 buffer zone with an ISO 5 primary engineering control, following USP <797> compounding standards for sterile preparations, and the final solution is drawn into 1 mL tuberculin syringes or filled into sterile multi-dose vials. Filter integrity after aseptic transfer is confirmed by bubble point testing on the 0.22 µm syringe filter, and each preparation is checked for visible particulate matter by inspection against a black and white background. The terminal product types are pre-filled syringes for individual animal administration and multi-dose vials for clinical wildlife centres. Because avian patients are often hypothermic and acidotic upon arrival, the dilution vehicle must be warmed to 35–37 °C before administration, and calcium-containing fluids are not mixed in the same syringe because precipitation with the dithiol chelator can occur under low pH conditions. Published data for this specific configuration are limited, but the main operational boundary is the short beyond-use life of the diluted solution, which is conventionally assigned 12 h at room temperature unless oxidative stability data indicate otherwise.
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Sodium Dimercaptopropane Sulfonate Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as a monohydrate crystalline powder, chemically described as 2,3-bis(sulfanyl)propane-1-sulfonic acid sodium salt; the monohydrate CAS is 207233-91-8 and the anhydrous CAS is 4076-02-2. The product descriptor is a single monohydrate crystalline powder model with grade variants defined by particle size, residual solvent, and endotoxin profile for the seven intended downstream presentations. The anhydrous molecular formula is C3H7NaO3S3, with a molecular weight of 210.27 g/mol; the monohydrate form contains an additional water molecule and has a molecular weight of 228.27 g/mol. The material appears as a white to off-white crystalline powder with high aqueous solubility due to the sulfonate anion, while the two adjacent thiol groups provide metal-binding activity. Unlike lipid-soluble dimercaprol, the sodium sulfonate salt remains largely in the aqueous phase, which reduces distribution into central nervous system tissue and permits formulation as an aqueous injection rather than an oil-based intramuscular depot. The API is not a premixed dosage form; its particle-size, residual solvent, and endotoxin profile must be selected to match the intended veterinary route and species.
The release dossier for a veterinary-grade DMPS sodium batch may include the following CMC parameters; each acceptance criterion is qualified against the approved veterinary medicinal product file and the relevant pharmacopoeial general chapter. Veterinary API manufacturing should follow ICH Q7 or EU GMP Part II; finished dosage forms follow 21 CFR 211 or EU GMP Part I where applicable. Assay by high-performance liquid chromatography with photodiode array detection is commonly controlled to 98.0–101.0% on the dried basis using USP <621> or Ph. Eur. 2.2.29 conditions. Loss on drying by USP <731> or Ph. Eur. 2.2.32 is typically set at not more than 5.0% for the monohydrate. Related substances, including the disulfide oxidation product, may be limited to a total of not more than 1.0%. Residual solvents are controlled under ICH Q3C and USP <467>; heavy metals may be controlled by Ph. Eur. 2.4.8 or USP <231>, with a typical limit of not more than 20 ppm. For parenteral-grade API, bacterial endotoxins are determined by Ph. Eur. 2.6.14 or USP <85>, and the limit is derived from the maximum intended veterinary dose rather than a fixed value.
| Parameter | Reference method | Common acceptance window |
|---|---|---|
| Appearance | Visual | White to off-white crystalline powder |
| Identification | Ph. Eur. 2.2.24 / USP <197> | Conforms to reference standard |
| Assay (dried basis) | Ph. Eur. 2.2.29 / USP <621> | 98.0–101.0% |
| Loss on drying | Ph. Eur. 2.2.32 / USP <731> | ≤ 5.0% |
| Related substances | Ph. Eur. 2.2.29 | Total ≤ 1.0% |
| Heavy metals | Ph. Eur. 2.4.8 / USP <231> | ≤ 20 ppm |
| Residual solvents | ICH Q3C / USP <467> | Class 3 solvents per option 1 |
| Bacterial endotoxins (parenteral) | Ph. Eur. 2.6.14 / USP <85> | Derived from maximum veterinary dose |
| Particle size (solid oral) | Laser diffraction, Ph. Eur. 2.9.31 | D90 ≤ 200 µm |
| Bulk density | Ph. Eur. 2.9.34 | 0.45–0.65 g/mL |
Particulate specifications vary by downstream format. A directly compressible tablet grade may require D90 below 200 µm and a bulk density of 0.45–0.65 g/mL; a premix grade may specify sieve retention through a 250 µm screen. For injection, the raw API is not a particulate dosage form but must meet low bioburden, endotoxin, and visible particle limits after compounding; dissolution and particulate matter tests are performed on the finished solution or tablet rather than on the API. Published data for the tightest veterinary batch specifications is limited; manufacturers should align the API acceptance criteria with the finished-product quality target product profile under the relevant veterinary GMP provisions.
In veterinary emergency medicine, the two sulfhydryl groups positioned on adjacent carbon atoms allow DMPS to form a stable five-membered chelate ring with trivalent arsenic, inorganic and organic mercury, lead, and, with lower affinity, cadmium. The sulfonate group remains ionized at physiological pH, so the resulting metal complex is water-soluble and undergoes renal elimination. Published toxicokinetic data in dogs and primates show a rapid distribution phase followed by urinary excretion of the DMPS-mercury complex; controlled pharmacokinetic studies in cattle, swine, and poultry are limited, and extrapolation from small-animal data requires species-specific dose justification. This chelator is used in veterinary practice for acute arsenic ingestion in cattle exposed to sodium arsenite dips, mercury toxicosis in companion animals, and lead exposure in avian species where parenteral access is difficult. In the United States, use in food-producing species may require compliance with extra-label use provisions of 21 CFR 530 and a valid Veterinary Client Patient Relationship, including an assigned meat and milk withdrawal interval if no approved product exists. No harmonized VICH monograph for DMPS sodium in food animals is available; field efficacy data are often drawn from case reports rather than multi-center trials.
Direct compression of DMPS sodium monohydrate at ambient relative humidity above 50–60% intensifies picking and sticking on rotary tablet presses equipped with D-tooling; granulated material with a loss on drying below 1.5% and a particle size D90 below 200 µm is typically required. Roller compaction at 30–50 bar hydraulic pressure or wet granulation with anhydrous ethanol may be employed because the sulfhydryl groups are oxidized by dissolved oxygen and catalyzed by trace Cu2+ and Fe2+ from equipment surfaces. Polished 316L stainless steel contact parts and nitrogen-blanketed granulators reduce oxidative dimerization to the disulfide. Povidone-based binders with measurable peroxide content should be excluded; if a binder is required, low-peroxide hydroxypropylcellulose or pregelatinized starch is preferable. Near-infrared moisture control at the granulator discharge is calibrated against Karl Fischer titration by USP <921> Method Ia; residual moisture above 2.0% at compression is associated with capping at press speeds above 30 rpm on single-station tooling, although specific limits vary with formulation. The finished tablet core should be packed in cold-form aluminum blisters with desiccant because moisture ingress above 60% RH produces surface discoloration and slows dissolution below the registered Q value in USP <711> testing.
When magnesium stearate is used as a lubricant, its level should not exceed 0.5% w/w; the free thiol can bind alkaline-earth metal ions at longer blending times, and lubricant migration onto the API surfaces slows hydration. Disintegration time for uncoated tablets is controlled by USP <701>; a maximum of 15 minutes in water at 37°C is a common release target. For capsules, low-moisture hard gelatin or hypromellose shells are preferred over high-moisture gelatin because water transfer from the shell to the API accelerates disulfide formation at the capsule wall.
For parenteral presentations, the API is dissolved in water for injection under nitrogen sparging to a concentration of 50 mg/mL, pH-adjusted with sodium hydroxide or hydrochloric acid to 6.0–7.0. The solution is filtered through 0.22 µm polyvinylidene fluoride or polyethersulfone membranes into inert Type I glass vials; oxygen headspace below 2% v/v is maintained by nitrogen overlay. Aseptic filtration is preferred when terminal sterilization at 121°C for 15 minutes has not been validated for a specific formulation, because thiol oxidation can generate disulfide-related substances. The finished injection should meet sterility by USP <71> or Ph. Eur. 2.6.1, bacterial endotoxins by USP <85> or Ph. Eur. 2.6.14, particulate matter by USP <788> or Ph. Eur. 2.9.19, and pH under the registered specification. Visible particle inspection should use a light obscuration method per USP <788>; the solution should remain colorless to pale yellow, and brown discoloration indicates disulfide accumulation requiring rejection. Accelerated stability at 40°C/75% RH in the commercial closure is used to bracket environmental exposure during shipment to tropical veterinary markets.
Feed premix applications present a specific redox conflict because finished rations commonly contain copper, iron, and zinc oxide at levels sufficient to catalyze thiol oxidation if free water activity exceeds 0.6 and oxygen is not excluded. Published data for DMPS stability in compounded feed is limited; therefore, a premix containing DMPS sodium should be evaluated by stability-indicating HPLC on the diluted feed at the intended trace-mineral concentration and storage interval. A conservative formulation approach places the API in a non-mineralized carrier such as lactose monohydrate or calcium carbonate, with a physical barrier to trace-mineral contact, and restricts contact with choline chloride or sulfate minerals. Homogeneity should be demonstrated by sampling at least 10 points across the mixer discharge and reporting relative standard deviation below 5.0%, using a validated assay. Oxidative loss may be monitored by the disulfide-to-parent peak ratio; a ratio above 0.10 may be used as an internal alert limit. When mineral overage is necessary to compensate for oxidative loss, the overage must be justified by batch recovery data under the worst-case storage condition; overtreatment with DMPS should not be attempted without veterinary supervision because renal elimination of the mobilized metal complex may transiently increase urinary metal concentration.
DMPS sodium differs from BAL in route flexibility and lipid solubility. BAL is a lipophilic dithiol that requires intramuscular injection in oil and penetrates the blood-brain barrier, which is relevant for neurotoxic metal burden but also produces a narrow therapeutic index. DMPS is water-soluble at veterinary dosing concentrations and can be administered orally or parenterally, with less central nervous system distribution. Compared with DMSA, the sodium sulfonate salt provides higher aqueous solubility and simpler parenteral formulation; DMSA as the free acid is typically limited to oral administration. Against calcium disodium EDTA, DMPS has a stronger affinity for soft metal cations such as mercury and arsenic, while EDTA is predominately a lead chelator and does not effectively bind mercury. EDTA also chelates essential zinc and manganese more aggressively, whereas DMPS has relatively lower affinity for alkaline earth metals. The following matrix summarizes the operational distinctions.
| Attribute | DMPS sodium | BAL | DMSA | EDTA calcium disodium |
|---|---|---|---|---|
| Primary target metals | Arsenic, mercury, lead | Arsenic, mercury, lead | Lead, mercury, arsenic | Lead |
| Aqueous solubility | High (sodium sulfonate salt) | Low; oil vehicle required | Low as free acid | High |
| Common routes | Oral, IV, IM | Deep IM only | Oral | IV, IM |
| Blood-brain barrier penetration | Limited | Significant | Limited | Minimal |
| Elimination | Renal | Biliary/renal | Renal | Renal |
| Key formulation liability | Thiol oxidation; hygroscopicity | Painful injection; toxicity | Low solubility; oral only | Essential metal depletion |
Encapsulation of DMPS sodium monohydrate on semi-automatic auger dosators requires densification to a Carr index below 25% and a minimum bulk density of 0.45 g/mL to ensure fill weight uniformity. Inclusion of colloidal silicon dioxide at 1–2% w/w and sodium starch glycolate at 2–5% w/w may improve flow; high-shear blending beyond 15 minutes generates electrostatic adhesion and should be avoided. Hard gelatin capsules filled with DMPS sodium should be packaged in amber glass or high-barrier blisters with desiccant, and storage above 25°C/60% RH may reduce assay below 95% within three months. For oral powders and granules, the API can be dry-blended with a non-reducing carrier such as mannitol or lactose monohydrate; aqueous granulation using starch paste is possible only if the drying step is conducted under vacuum below 50°C to limit disulfide formation. Ready-to-use solutions for oral administration are usually compounded at the pharmacy or farm from the powder; because the thiol groups are oxygen-sensitive, the solution should be dispensed in amber glass and used within 24 hours when stored at 2–8°C, unless a stability study supports a longer in-use period.
