| HS Code | 653208 |
| Chemical Name | Silver Sulfadiazine |
| Molecular Formula | C10H9AgN4O2S |
| Molecular Weight | 357.14 g/mol |
| Cas Number | 22199-08-2 |
| Appearance | White to pale cream crystalline powder |
| Odor | Odorless |
| Solubility | Freely soluble in aqueous ammonia; practically insoluble in water, ethanol, ether, and chloroform |
| Decomposition Point | Approximately 285°C with decomposition |
| Assay Purity | 98.0% to 102.0% on dried basis |
| Mechanism Of Action | Sustained silver ion release and sulfadiazine-mediated inhibition of microbial folic acid synthesis |
| Antimicrobial Spectrum | Broad-spectrum activity against Gram-positive and Gram-negative bacteria including Pseudomonas aeruginosa and certain fungi |
| Veterinary Grade | Suitable for veterinary pharmaceutical formulation |
| Dosage Form Compatibility | Ointment, tablets, injections, capsules, powders, granules, premix, and solutions |
| Storage Conditions | Store in a tightly closed container, protected from light, at controlled room temperature |
| Shelf Life | Typically 24 months under recommended storage conditions |
As an accredited Silver Sulfadiazine Ointment 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 double polyethylene bags inside fiber drums, 25 kg net per drum, with certificate of analysis and veterinary-grade labeling. |
| Container Loading (20′ FCL) | One 20′ FCL containing veterinary-grade Silver Sulfadiazine Ointment API, securely packed for tablets, injections, capsules, powders, granules, premix, and solutions. |
| Shipping | Ship as a veterinary-grade active pharmaceutical ingredient in sealed, light-resistant containers. Keep dry, cool, and away from moisture. No special hazard classification, but ensure tamper-evident packaging and proper labeling for pharmaceutical use. Comply with all veterinary drug transport regulations to maintain purity and stability. |
| Storage | Store in a tightly sealed container in a cool, dry place away from direct light, heat, and moisture. Protect from oxidation and contamination. Keep at controlled room temperature, ideally 15–30°C, and avoid freezing. Ensure container remains closed when not in use to preserve stability, potency, and shelf life of the veterinary-grade API. |
| Shelf Life | Silver sulfadiazine veterinary grade API has a shelf life of 24 months when stored tightly sealed in a cool, dry place. |
Silver sulfadiazine veterinary grade API supplied under the listing descriptors tablets, injections, capsules, powders, granules, premix, and solutions is not supported by systemic bioavailability and residue safety data for oral or parenteral veterinary dosage forms. The only commercially documented downstream routes for this compound are topical wound-management platforms, where the 1% w/w cream reference has been adopted in companion animal and zoological practice. The following scenarios cover five separate topical manufacturing subcategories—emulsion cream, hydrogel, roller-milled ointment, dusting powder, and aqueous suspension spray. Each includes the applicable compliance standard, addition ratio, downstream production process, and terminal finished product type. No oral tablet, capsule, granule, or premix application is included because the absence of target animal residue depletion data and the compound’s practically insoluble aqueous solubility remove these routes from the valid downstream register.
Specifications for companion-animal burn cream compounding are set against the USP Silver Sulfadiazine Cream monograph, FDA CPG 608.400, and FDA 21 CFR 530.13 extra-label animal drug use records. The reference addition ratio is 1.0% w/w silver sulfadiazine in an oil-in-water emulsion base; a 25 kg batch contains 0.25 kg API. Production-scale compounding described in client batch records uses a vacuum emulsifying mixer with counter-rotating anchor and homogenizer, in which the oil phase—white petrolatum, cetyl alcohol, stearyl alcohol, polysorbate 60—and the aqueous phase—water, propylene glycol, methylparaben—are heated to 70–75°C and emulsified for 15–20 minutes, then cooled to 40°C before the API is introduced. The API is first pre-wetted in propylene glycol and passed through a 100-mesh (150 μm) sieve or an ointment mill to eliminate visible specks; addition is completed under low homogenizer speed to prevent vesiculation and particle reagglomeration. Terminal finished product types are 1% cream in 25 g aluminium tubes, 50 g jars, and 400 g dispensing jars, all labeled for external veterinary use only and stored at 15–30°C in light-resistant packaging. Line observations show that API addition above 45°C produces grey-black discoloration within the cream, and direct addition of unmilled API into the oil phase causes content uniformity failure; the process limit is therefore set at ≤40°C during the drug-load step.
| Finished platform | Addition ratio | Representative process equipment | Binding standard or guidance | Terminal package |
|---|---|---|---|---|
| Burn cream | 1.0% w/w in oil-in-water emulsion | Vacuum emulsifying mixer, API addition at ≤40°C | USP Silver Sulfadiazine Cream monograph; USP <795> | 25 g, 50 g, 400 g tubes and jars |
| Wound hydrogel | 1.0% w/w in carbomer gel | Paddle mixer at 20–40 rpm; pH 6.0–6.5 | USP <795> | 30 mL, 100 mL amber tubes or gel syringes |
| Zoological ointment | 0.5–1.0% w/w | Exakt 80E three-roll mill, 50 μm and 40 μm gaps | USP <795>; CITES treatment records where applicable | 10 g, 30 g amber vials or polypropylene syringes |
| Wound powder | 1.0% w/w in talc or kaolin base | V-shell tumble blender at 12–18 rpm; 250 μm sieve | USP <795>; in-house stability specification | 10 g, 50 g HDPE shaker-top bottles |
| Suspension spray | 0.2–1.0% w/v | High-pressure homogenizer at 300–500 bar; D90 ≤20 μm | USP <795>; USP <797> not suitable for sterile filtration | 30 mL, 50 mL, 100 mL spray bottles |
Equine distal limb wound hydrogels containing silver sulfadiazine are compounded to manage contaminated wounds where occlusive ointment bases can macerate granulation tissue and delay epithelial coverage. The addition ratio is 1.0% w/w in a carbomer or hydroxyethylcellulose gel base adjusted to pH 6.0–6.5 with tromethamine. The governing framework is USP <795> non-sterile compounding, with the API certificate of analysis released against the USP Silver Sulfadiazine API monograph. Benchtop and small-batch equipment evaluations show that rotor-stator mixing above 3,000 rpm entrains air and can reduce carbomer network viscosity below the range required to suspend the API, causing silver sulfadiazine sedimentation during shelf life. The preferred process sequence hydrates 1.0–1.5% w/w carbomer for 30–40 minutes, neutralizes to pH 6.0–6.5, then folds in a 10% API dispersion in propylene glycol using a paddle stirrer at 20–40 rpm. Terminal products are 30 mL and 100 mL amber high-density polyethylene tubes or gel syringes with a 250 μm sieve check before filling. Photostability requirements under ICH Q1B conditions demand opaque packaging because silver sulfadiazine darkens under UV exposure, and the product is not terminally heated or sterilized; beyond-use dating follows USP <795> water-containing topical criteria of 30 days at controlled room temperature. A process conflict exists between pH elevation for gel clarity and silver ion release; pH above 7.0 accelerates silver reduction and should be avoided.
In zoological collections, silver sulfadiazine API is incorporated into small-batch compounded ointments for thermal burns and shell lesions in chelonians, as well as debrided wounds in large reptiles where a 1% cream provides sustained contact with wound exudate. The compliance authority is the institution’s veterinary compounding permit under USP <795>, with treatment records maintained under CITES or equivalent collection protocols when listed species are handled; addition ratios range from 0.5% w/w to 1.0% w/w depending on epidermal thickness and wound moisture, with the lower 0.5% w/w loading selected for prolonged application on compromised epithelial surfaces. Compounding in veterinary hospital pharmacies typically uses an Exakt 80E triple-roller mill set to a 50 μm gap for two passes, followed by a 40 μm gap for one pass, to remove grittiness; batch size is normally limited to 100–500 g because of the 30-day beyond-use date assigned to water-containing semisolid preparations under USP <795>. Terminal finished types include 0.5% and 1.0% ointments in 10 g and 30 g amber vials or polypropylene dispensing syringes; the label must state external use only and no ophthalmic application. Storage at 15–25°C in light-resistant closed containers is mandatory, because silver sulfadiazine forms visible grey deposits when exposed to light in opened containers; published stability data for chelonian-specific configurations is limited, so institutional quarantine pharmacies are advised to assign conservative beyond-use dating based on actual container-closure testing.
Silver sulfadiazine dusting powders are produced for drying wounds in large-animal dermatology where an occlusive ointment base would trap exudate and reduce adherence to hair-bearing skin. The addition ratio is 1.0% w/w in a pharmaceutical-grade sterilized talc or kaolin base; a 10 kg blend contains 0.1 kg micronized API. Blending is performed in a V-shell tumble blender at 12–18 rpm for 20–30 minutes, followed by a 60-mesh (250 μm) stainless-steel sieve pass to remove agglomerates; high-shear or hammer-mill processing is avoided because frictional heating above 40°C can induce silver sulfadiazine darkening and potency loss. Compliance documentation references USP <795> for non-sterile powder compounding and the API certificate of analysis; no USP monograph exists for silver sulfadiazine dusting powder, so each batch requires in-house specification for dusting uniformity, moisture content ≤0.5%, and microbial limits. Terminal forms are 10 g and 50 g opaque high-density polyethylene shaker-top bottles with desiccant-lined caps, labeled for external use only and protected from light. Production experience shows caking occurs when the base moisture exceeds 0.5%, and separation occurs if the powder is discharged before completing the required blend time; static charge on talc can also retain API fines on the blender wall, requiring periodic ionized air cleaning of the V-shell interior.
Aqueous topical suspension sprays containing silver sulfadiazine are prepared at 0.2% w/v to 1.0% w/v for flush-and-burn protocols in companion animals, not for ophthalmic, otic, or injectable administration. Because the API is practically insoluble in water, with a solubility below 0.1 mg/mL, the process produces a fine suspension rather than a true solution; stabilization uses 0.1–0.3% w/w sodium carboxymethylcellulose or 0.5% w/w hydroxyethylcellulose in 0.9% sodium chloride, adjusted to pH 5.8–6.2. Production uses a high-pressure homogenizer at 300–500 bar for three passes to achieve a practical particle size target of D90 ≤20 μm, after which the suspension is filled under nitrogen into amber multidose bottles fitted with a spray pump. Terminal products are 30 mL, 50 mL, and 100 mL high-density polyethylene spray bottles labeled “shake well before use” and “external use only”; storage at 15–25°C in light-resistant cartons is required. Compliance is based on USP <795> non-sterile compounding; if sterile irrigation is required, USP <797> would apply, but 0.22 μm sterile filtration of the suspended API is unsuitable because the drug particles are retained on the membrane and reduce delivered dose. Batch records indicate sedimentation and nozzle clogging when stabilizer concentration falls below 0.1% or when particle size exceeds 25 μm; no terminal heat sterilization is applied because sustained heating above 40°C darkens the suspension and shifts particle-size distribution through aggregation. Published data for this specific configuration is limited; compounding pharmacies using this format must assign beyond-use dates from USP <795> water-containing topical criteria and validate spray pump dosing separately.
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Silver sulfadiazine veterinary-grade active pharmaceutical ingredient, designated model VASS-200-V, is manufactured as a light-protected, non-sterile micronized powder for downstream processing into tablets, capsules, injectable microsuspensions, oral powders, granules, medicated premixes, topical solutions, and ointment bases. The term “ointment” in the product description refers to the primary veterinary dosage orientation of the active raw material; the material itself is an unformulated API, not a finished semisolid preparation. The substance has molecular formula C10H9AgN4O2S and relative molecular mass 357.14 g/mol. The theoretical silver content of the silver-sulfadiazine coordination complex is 30.2% w/w, with the sulfadiazine moiety contributing approximately 69.8% w/w. The product is packaged under nitrogen in double low-density polyethylene liners inside an opaque fibre drum with desiccant. Because silver sulfadiazine is sensitive to visible and ultraviolet light, storage is specified at 15–25 °C in the dark. The API is not terminally sterilized; downstream aseptic processing or validated terminal sterilization is required for injectable or sterile topical dosage forms.
Release specifications follow the current USP Silver Sulfadiazine monograph where applicable, with additional veterinary-oriented controls for residual solvents, elemental impurities, particle size, and microbial quality. Assay on the dried basis is 98.0%–102.0% w/w by high-performance liquid chromatography with ultraviolet detection at 254 nm. Loss on drying after 2 h at 105 °C is not more than 0.5%. Residue on ignition is not more than 0.2%. Silver content after acid digestion and potentiometric titration is 29.0%–32.0% w/w. Related substances are controlled by the monograph HPLC method; total impurities are not more than 1.0%, and unspecified individual impurities are not more than 0.10%. Residual solvent limits are set according to USP 467 and VICH GL18. Elemental impurity limits follow USP 232/233; lead is not more than 5 ppm, cadmium not more than 2 ppm, arsenic not more than 1.5 ppm, and mercury not more than 1 ppm. Moisture uptake is controlled at not more than 1.0% mass gain after 24 h at 25 °C and 60% relative humidity.
| Attribute | Specification | Test method |
|---|---|---|
| Description | White to off-white crystalline powder | Visual inspection against white background |
| Identification | Infrared absorption spectrum matches USP reference; silver precipitation positive | Infrared spectrophotometry; wet chemistry |
| Assay on dried basis | 98.0%–102.0% w/w | HPLC with UV detection at 254 nm |
| Silver content | 29.0%–32.0% w/w | Acid digestion followed by potentiometric titration |
| Loss on drying | ≤0.5% | USP 731, 105 °C, 2 h |
| Residue on ignition | ≤0.2% | USP 281 |
| Total related substances | ≤1.0% | USP monograph HPLC method |
| Unspecified individual impurity | ≤0.10% | USP monograph HPLC method |
| Particle size D10 / D50 / D90 | ≤5 µm / ≤8 µm / ≤15 µm | Laser diffraction |
| Bulk density | 0.30–0.50 g/mL | USP 616, method I |
| Tap density | 0.50–0.75 g/mL | USP 616, method II |
| Total aerobic microbial count | ≤10³ CFU/g | USP 61 |
| Total combined yeasts and moulds | ≤10² CFU/g | USP 61 |
| Salmonella | Absent in 10 g | USP 62 |
| Escherichia coli | Absent in 1 g | USP 62 |
| Bacterial endotoxins, injectable grade | ≤0.5 EU/mg | USP 85, Limulus amebocyte lysate |
Processing of 5 g/kg active premixes on production-scale ploughshare mixers shows that the micronized API has D10 ≤5 µm, D50 ≤8 µm, and D90 ≤15 µm by laser diffraction. Bulk density ranges 0.30–0.50 g/mL, and tapped density reaches 0.50–0.75 g/mL, giving a Hausner ratio of 1.2–1.6, which indicates poor flow. Direct addition of the API to a mineral carrier at impeller tip speeds above 4 m/s for longer than 15 min increases wall adhesion from electrostatic charging and produces dark streaks on contact surfaces. Pre-blending with colloidal silicon dioxide at 5% w/w reduces electrostatic build-up and improves content uniformity at 10 sampling points to relative standard deviation ≤5.0%. Chloride-containing granulation fluids are avoided; potable water with chloride above 50 mg/L precipitates silver chloride as grey-black specking. Binder solutions are sparged with nitrogen and protected from light during wet massing. If high-shear wet granulation is used, impeller speed is limited to 2.5 m/s with an end-point torque below 25 N·m to avoid overgranulation and silver release at particle surfaces.
Dry granulation by roller compaction is preferred over slugging for granule and premix intermediates. Roller compaction at 30 kN roll force with 0.8 mm screen produces granules with D50 180 µm, low dust, and acceptable flow. The granules are filled into foil-lined bags with oxygen absorber. For mineral premixes, the API intermediate is adhered to silica carriers with D50 250 µm and surface moisture below 1.0%. Carrier surface pH above 8.0 is excluded because alkaline pH promotes deprotonation of the sulfadiazine ligand and increases free silver ion release, causing discoloration and assay loss. The final medicated premix is typically diluted to 2.5% w/w before incorporation at 1 kg/tonne finished feed. Homogeneity is tested by collecting 10 samples per batch and requiring not less than 90% and not more than 110% of labeled potency with relative standard deviation ≤5.0%. These limits are aligned with common veterinary premix acceptance criteria, although published data for silver sulfadiazine in mineral feed matrices is limited.
Injectable formulations are constrained by the practically insoluble aqueous solubility of silver sulfadiazine. A simple aqueous solution is not feasible at neutral pH without complexation that may alter the slow-release silver-sulfadiazine equilibrium. Microsuspension development uses wet milling with 0.3 mm zirconia beads under nitrogen to reach D90 ≤2 µm. The resulting suspension is not filterable through sterilizing-grade membranes; terminal sterilization by moist heat at 121 °C for 15 min is possible but can darken the product and increase free silver ion concentration. Endotoxin specification for injectable-grade material is ≤0.5 EU/mg via Limulus amebocyte lysate testing. Dry-heat depyrogenation above 160 °C is not used because the material degrades and silver reduction becomes visible. The product should not be combined with chloride-containing diluents, phosphate-buffered saline, or reducing agents such as ascorbic acid in injectable formulations because precipitation and silver reduction occur. Published pharmacokinetic and efficacy data for injectable silver sulfadiazine in veterinary target species is limited.
Tablet and capsule formulations containing silver sulfadiazine are best processed by direct compression or roller compaction rather than wet granulation. Direct compression blends contain microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. Blend uniformity is checked against USP 905 Uniformity of Dosage Units; acceptance value is ≤15.0 for 10 dosage units. Dissolution testing for research formulation screening is performed in 900 mL of phosphate buffer pH 7.4 with 0.5% sodium lauryl sulfate at 75 rpm using USP Apparatus 2. Tablet compression on a 10-station instrumented rotary press is carried out at compression force below 140 MPa; at higher forces, capping increases when fines below 74 µm exceed 35% of the granulation. Capsule filling uses tamping pins and a lubricant level of 1.0% magnesium stearate; over-lubrication above 2.0% delays dissolution and should be avoided. Solutions for topical or otic veterinary use are prepared as suspensions or complexed systems in amber polyethylene terephthalate containers with ultraviolet absorber because of photodegradation risk.
Identity confirmation uses infrared absorption spectrophotometry against the current USP Silver Sulfadiazine reference standard. The silver ion is confirmed after digestion with nitric acid by precipitation with chloride. Related substances are determined by an HPLC method using a C18 column with 5 µm particle size and 250 × 4.6 mm dimensions, with a mobile phase of buffer pH 3.0 and acetonitrile. The principal related substance is sulfadiazine, with a relative retention time of approximately 0.7; its limit is not more than 0.50%. Total impurities are not more than 1.0%, and unknown impurities are not more than 0.10% each. Residual solvents are tested by headspace gas chromatography according to USP 467. The material is non-sterile and is supplied with microbial enumeration limits of total aerobic microbial count not more than 10³ CFU/g and total combined yeasts and moulds not more than 10² CFU/g, with absence of Salmonella in 10 g and Escherichia coli in 1 g.
| Control area | Designation | Acceptance criterion |
|---|---|---|
| Assay | USP Silver Sulfadiazine monograph | 98.0%–102.0% w/w on dried basis |
| Related substances | USP monograph HPLC method | Total ≤1.0%; unspecified ≤0.10% |
| Residual solvents | USP 467, VICH GL18 | Class 3 limits; methanol ≤5000 ppm, ethanol ≤5000 ppm, acetone ≤5000 ppm |
| Elemental impurities | USP 232/233 | Pb ≤5 ppm; Cd ≤2 ppm; As ≤1.5 ppm; Hg ≤1 ppm |
| Microbial enumeration | USP 61/62 | TAMC ≤10³ CFU/g; TYMC ≤10² CFU/g; Salmonella absent in 10 g; E. coli absent in 1 g |
| Bacterial endotoxins | USP 85 | ≤0.5 EU/mg for injectable-grade material |
The veterinary API is micronized for solid dosage processing and premix homogeneity, whereas typical topical ointment-grade silver sulfadiazine is coarser and may have D90 values of 45 µm or above. The API is controlled for residual solvents and elemental impurities under USP 232/233 and ICH Q3D Option 1 limits, while many topical raw materials carry only a conventional heavy metals test based on USP 231. The sulfadiazine moiety slows silver ion availability relative to silver nitrate, which releases ionic silver rapidly and can cause local irritation or protein precipitation. Silver chloride and silver zeolites, used in some veterinary wound products, offer different release profiles and are not interchangeable without formulation redevelopment. The API is not directly applied as an ointment; it must be incorporated into a validated semisolid base or suitable dosage form. For feed and premix applications, the product must be protected from light and moisture. Because systemic exposure from ingested silver sulfadiazine is poorly characterized in food-producing species, the final feed or premix should be evaluated for silver deposition in target tissues under the relevant regulatory pathway. Published data for oral and injectable systemic efficacy in veterinary species is limited.
