| HS Code | 159715 |
| Product Name | Vedaprofen Veterinary Grade API |
| Synonyms | Vedaprofen, (+/-)-Vedaprofen |
| Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Cas Number | 71109-09-6 |
| Molecular Formula | C15H20O2 |
| Molecular Weight | 232.32 g/mol |
| Chemical Class | Non-Steroidal Anti-Inflammatory Drug (NSAID), propionic acid derivative |
| Appearance | White or almost white crystalline powder |
| Solubility | Practically insoluble in water; freely soluble in acetone, ethanol, and methylene chloride |
| Melting Point | Approximately 93-95°C |
| Pka | Approximately 4.2-4.4 |
| Storage Conditions | Store in a well-closed container, protected from light and moisture, at controlled room temperature 2-30°C |
| Shelf Life | Typically 24-36 months when stored in unopened original container under recommended conditions |
| Assay | 98.0% - 102.0% on dried basis |
| Residual Solvents | Meet ICH Q3C requirements |
| Veterinary Compliance | Suitable for veterinary pharmaceutical manufacturing and quality control per relevant standards |
As an accredited Vedaprofen 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 | Vedaprofen Veterinary Grade API is packed as 25 kg in double-lined polyethylene bags inside sealed fibre drums, suitable for formulations. |
| Container Loading (20′ FCL) | One 20′ FCL loaded with palletized, sealed drums of Vedaprofen Veterinary Grade API, securely stowed for safe transit. |
| Shipping | Vedaprofen Veterinary Grade API ships in sealed, UN-approved containers with tamper-evident seals to prevent contamination. Transport under ambient conditions, protected from moisture and direct sunlight. Include SDS, Certificate of Analysis, and customs documentation. Comply with local pharmaceutical handling regulations for veterinary APIs to ensure safe, traceable delivery worldwide. |
| Storage | Store Vedaprofen Veterinary Grade API in a well-closed, tightly sealed container, protected from light and moisture. Keep in a cool, dry, well-ventilated area at controlled room temperature (15–30°C). Avoid exposure to excessive heat, humidity, and freezing. Retain in original packaging until use. Follow manufacturer’s expiry guidance and ensure proper handling under clean conditions. |
| Shelf Life | Shelf life is typically 24 months when stored in a cool, dry, airtight container, protected from light and moisture. |
In direct compression of vedaprofen for canine osteoarthritis tablets, the micronized API is first passed through a 0.8 mm stainless steel security sieve and then combined with a preblend of lactose monohydrate and microcrystalline cellulose in a 600 L tumble blender; particle size of the API is controlled at D90 ≤ 20 µm by laser diffraction per ISO 13320:2020. The formulation addition ratio in the tablet core is typically 5.0% to 25.0% w/w, depending on whether the target dose is 20 mg, 50 mg, or 100 mg and the total core mass is adjusted to 200 mg–400 mg. Release testing is aligned with Ph. Eur. 2.9.5 uniformity of dosage units, 2.9.3 dissolution with Apparatus 2 at 50 rpm in 900 mL pH 6.8 phosphate buffer, and 2.9.7 friability at 100 revolutions; because a public monograph for the tablet form is not available, the dissolution medium is selected by in-house solubility screening. Roller compaction is used instead of direct compression to reduce segregation of the low-dose API; the ribbon density is maintained at 0.85–1.05 g/cm³, and the granulate is milled through a 0.8 mm screen before tabulating on a 16-station B-tooling rotary press with precompression 4–8 kN and main compression 8–14 kN. Hardness is kept at 60–90 N to avoid lamination while maintaining disintegration below 15 min per Ph. Eur. 2.9.1. On production-scale equipment, batch-to-batch shifts in API D90 from 18 µm to 26 µm have been associated with granulate fines below 63 µm exceeding 30%, which causes feed frame bridging when press speed exceeds 45 rpm; this is controlled by re-screening and by lowering press speed rather than by increasing magnesium stearate above 1.0% w/w. Residual solvents from the API synthesis are controlled per VICH GL18 and ICH Q3C; methanol, if used in final recrystallization, is limited to 3000 ppm. Terminal finished product types include 20 mg, 50 mg, and 100 mg uncoated tablets packed in PVC/PVDC blisters under low oxygen conditions.
For aseptic manufacture of vedaprofen injection at 2.0% to 5.0% w/v, the API is dissolved in a buffered vehicle containing propylene glycol, ethanol, and water for injection, with pH adjusted to 7.4–8.0 using sodium hydroxide; this pH window keeps the free acid soluble while avoiding excessive alkaline hydrolysis during the holding period. The solution is passed through a 0.45 µm polypropylene prefilter and then through two 0.22 µm PVDF membrane filters in series before filling; filter integrity is tested by bubble point and diffusion flow per the filter manufacturer’s validated protocols. The cleanroom background is maintained at ISO 14644-1 ISO 7 for preparation and ISO 5 for critical filling zones, with continuous particle monitoring per ISO 14644-2:2015. Release testing includes Ph. Eur. 2.6.1 sterility by membrane filtration, 2.6.14 bacterial endotoxins using a 0.25 EU/mL endpoint, 2.9.19 subvisible particulate content for parenteral preparations, and 2.9.20 visible particles. Dissolved oxygen in the bulk solution is reduced to below 0.5 mg/L by nitrogen sparging, and the filling line uses peristaltic pumps with 316L stainless steel needles to avoid metal-ion catalyzed oxidation. Because published thermal degradation data for vedaprofen under steam sterilization conditions remain limited, terminal sterilization should not be assumed; aseptic filtration is retained unless forced degradation screening per VICH GL5 demonstrates a safety margin. Injectable tanks are equipped with bottom-mounted magnetic stirrers operating at 150–250 rpm to dissolve the API without excessive vortexing; holding time between dissolution and sterile filtration is limited to 8 h at 20–25°C to minimize bioburden growth and degradation. Terminal finished product types are single-dose 20 mg/mL and 50 mg/mL Type I glass vials filled at 2 mL and 10 mL fill volumes, sealed with chlorobutyl rubber stoppers and flip-off aluminum caps.
Oral solutions at 100 mg/mL are prepared by dissolving vedaprofen at 10.0% w/v in a vehicle composed of purified water, propylene glycol, and sodium hydroxide; the addition ratio is fixed by the target 100 mg/mL concentration and the final density of the vehicle, which is typically 1.02–1.06 g/mL at 20°C measured by Ph. Eur. 2.2.5 relative density. The solution is mixed in a 200 L stainless steel vessel with a top-mounted high-shear mixer at 400–600 rpm until visual clarity is confirmed; pH is adjusted to 7.2–7.6 and verified with a calibrated Ph. Eur. 2.2.3 pH meter, because lower pH reduces solubility and higher pH accelerates oxidative discoloration. The liquid is filtered through a 5 µm polypropylene depth filter to remove minor particulate and then filled into 30 mL and 100 mL HDPE bottles with low-density polyethylene dropper plugs and child-resistant closures. Release testing includes assay by HPLC with in-house validation, related substances by gradient HPLC, and preservative content if the product is configured as a multi-dose container; microbial quality is assessed per Ph. Eur. 5.1.4 for non-sterile oral liquids. Residual solvent limits follow ICH Q3C, and stability is assigned by bracketing per VICH GL5; published forced degradation data for this specific aqueous vehicle are limited, so photostability testing per VICH GL3 is performed before launch. Cold storage below 4°C can cause transient precipitation in some batches; in-use stability with repeated dosing from the same bottle is validated over 30 days at 25°C/60% RH. Terminal finished product types are 100 mg/mL equine oral solution bottles with graduated dosing syringes, packaged in cartons with tamper-evident seals.
Low-dose vedaprofen capsules are compounded from a roller-compacted granulate rather than a simple powder blend because the API’s micronized fraction tends to migrate to the bottom of the hopper when blend density falls below 0.50 g/mL. The formulation addition ratio for hard gelatin capsules is set between 8.0% and 15.0% w/w, with the remainder consisting of lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and 0.5% w/w colloidal silicon dioxide to improve flow. The granulate is produced on a 120 kg/h roller compactor with roll pressure 30–50 kN and milled through a 1.0 mm stainless steel screen; the resulting granules are controlled at 200–800 µm by Ph. Eur. 2.9.38 sieve analysis, with fines below 125 µm limited to 20% maximum. Uniformity of mass is monitored during encapsulation on a dosator-type capsule filler operating at 25,000–30,000 capsules/h; fill weight drift is restrained by maintaining bulk density at 0.55–0.65 g/mL and by setting dosator compression thickness within 2.0–4.0 mm. Release testing includes Ph. Eur. 2.9.5 uniformity of content, 2.9.1 disintegration with water at 37°C and 30 cycles/min, and 2.9.3 dissolution in 900 mL pH 6.8 phosphate buffer at 75 rpm for capsules. Residual moisture in the filled capsules is kept below 3.0% w/w by Karl Fischer titration per Ph. Eur. 2.5.12, because higher moisture softens gelatin shells and accelerates API hydrolysis in the presence of free water. On production-scale lines, encapsulation rooms are maintained at 40–50% RH and 18–22°C; failure to do so has resulted in shell brittleness at low humidity and sticking at high humidity. Terminal finished product types are size 3, 2, and 1 hard gelatin capsules containing 25 mg, 50 mg, and 100 mg vedaprofen, packed in HDPE bottles with desiccant canisters.
Granulation of vedaprofen for oral sachets is driven by the need to reduce dusting, improve reconstitution behavior in soft food, and limit segregation during sachet filling at high speed. The formulation addition ratio is typically 5.0% to 25.0% w/w, corresponding to 50 mg/g to 250 mg/g active content in the final granule blend. The process uses a high-shear wet granulator with 3.0% w/w povidone K30 dissolved in purified water as the binder; the wet mass is passed through a 1.0 mm screen and dried in a fluid-bed dryer with inlet air temperature 60–65°C until loss on drying reaches 1.5–2.0% w/w by Ph. Eur. 2.2.32. Dried granules are milled and classified to 200–800 µm; particles below 150 µm are limited to 25% to avoid poor flow into vertical form-fill-seal sachet lines. The filling machine uses auger or cup-fill dosing heads and runs at 60–80 sachets/min for 1 g, 2 g, and 5 g fill weights. Release testing includes assay, uniformity of mass at 2.9.5, moisture per 2.2.32, and granule friability by an in-house method calibrated against Ph. Eur. 2.9.7; dissolution is not applied to bulk granules, but in-process disintegration of the granulate in water at 37°C is assessed by a simplified 2.9.1 method. Because published stability data for vedaprofen in granule form remain limited, a bracketing stability protocol per VICH GL5 with two container sizes and at least three API concentrations is recommended. Terminal finished product types include 1 g sachets containing 100 mg vedaprofen, 2 g sachets containing 200 mg, and 5 g sachets containing 500 mg, sealed in aluminum foil laminates with low water vapor transmission rates.
Premix manufacture is constrained by the hygroscopic nature of some vedaprofen granulations and by the need to maintain blend homogeneity at low concentrations in a carrier. The formulation addition ratio in a non-food veterinary premix is generally 1.0% to 10.0% w/w, with the API distributed onto a carrier of lactose monohydrate or dextrose in a 500 L ribbon blender; a geometric dilution sequence is used before the final blend step at 12 rpm for 20 min after the API component has been pre-blended for 5 min with 2.0% w/w hydrophobic fumed silica. Blending area conditions are controlled at 25–35% RH and 18–22°C, because prolonged exposure above 60% RH produces cohesive aggregates that introduce assay variability outside 95–105% of label claim. Homogeneity is verified by Ph. Eur. 2.9.38 particle size distribution and by stratified sampling across the discharge port, with acceptance limits of 90–110% label claim and relative standard deviation below 5.0%. Commercial release includes assay, related substances, water content by Ph. Eur. 2.2.32, and bulk powder flow through an orifice per Ph. Eur. 2.9.36. Because vedaprofen is not approved for food-producing animals in major regulatory jurisdictions, any premix use must be restricted to companion animals or non-food equine patients and the label must state this restriction explicitly. Terminal finished product types are 5 g/kg, 10 g/kg, and 25 g/kg non-food oral premixes packed in multiwall paper bags with polyethylene liners and sealed with desiccant sachets; the powder is intended for top-dressing on feed or for reconstitution by a veterinarian before administration.
Competitive Vedaprofen Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
Flexible payment, competitive price, premium service - Inquire now!
Vedaprofen Veterinary Grade API is a racemic propionic acid derivative, (RS)-2-[4-(cyclohexyl)naphthalen-1-yl]propanoic acid, CAS 71109-09-6, molecular formula C19H22O2, molecular weight 282.38 g/mol. The API is released for downstream manufacture of tablets, injectable solutions, capsules, powders, granules, premix, and oral solutions. Route-specific grade designations are used: VP-O for oral solid dosage, VP-I for injectable and solution formats, and VP-PM for premix and feed-grade granulation. The molecule inhibits prostaglandin synthesis through cyclooxygenase inhibition; published comparative COX-1/COX-2 potency data show species- and assay-dependent variation. Finished-dose clinical indications, target-species safety margins, and residue depletion data remain the responsibility of the marketing authorization holder.
Identification is confirmed by infrared absorption spectrophotometry according to Ph. Eur. 2.2.24. Assay is determined by liquid chromatography according to Ph. Eur. 2.2.29 and controlled at 98.0–102.0% on dried basis. Water content by Karl Fischer titration per Ph. Eur. 2.5.12 is maintained at ≤0.5% for VP-O and VP-I, and ≤1.0% for VP-PM. Sulfated ash per Ph. Eur. 2.4.14 is controlled at ≤0.1%. Related substances are quantified by gradient HPLC; total impurities are limited to ≤0.5%, with any unspecified impurity ≤0.10%. Residual solvents are tested by headspace gas chromatography under Ph. Eur. 5.4 and VICH GL18, with class 1 solvents absent and class 2 solvents at or below the concentration limits listed in VICH GL18. Elemental impurities are managed by a risk assessment aligned with ICH Q3D; for parenteral-grade material, cadmium, lead, arsenic, and mercury are controlled by validated ICP-MS methods.
The free acid requires basic pH for sufficient aqueous solubility. Below pH 6.0, solubility decreases sharply, and formulations intended for injection or oral solution typically require neutralization with sodium hydroxide or meglumine. The API is sensitive to oxidation and photodegradation, and bulk material is protected from light in sealed packaging. These physicochemical constraints define the grade selection and processing limits described in Table 1.
| Parameter | Oral/tablet grade | Injectable/solution grade | Premix/granule grade |
|---|---|---|---|
| Laser diffraction D50 per Ph. Eur. 2.9.31 | 30–60 µm | ≤15 µm for rapid dissolution | 50–150 µm |
| Water content per Ph. Eur. 2.5.12 | ≤0.5% | ≤0.5% | ≤1.0% |
| Bulk density per Ph. Eur. 2.9.34 | 0.35–0.55 g/cm³ | 0.20–0.45 g/cm³ | 0.45–0.65 g/cm³ |
| Total aerobic microbial count per Ph. Eur. 2.6.12 | ≤10² CFU/g | ≤10¹ CFU/g before terminal sterilization | ≤10³ CFU/g |
| Bacterial endotoxins per Ph. Eur. 2.6.14 | not typically specified | dosage-specific via K/M per Ph. Eur. 5.1.10 | not typically specified |
In tablet and capsule manufacture, VP-O is passed through a 40–60 mesh screen before blending. Direct compression on 16-station B-tooling rotary presses requires a laser diffraction D50 of 30–60 µm and D90 ≤150 µm to avoid segregation from lactose monohydrate and microcrystalline cellulose. Content uniformity for low-dose tablets with label claims between 1.0 mg and 5.0 mg is assessed using the acceptance value calculation in Ph. Eur. 2.9.40. In production batches, colloidal silicon dioxide at 0.5% w/w and magnesium stearate at 0.5–1.0% w/w are used to reduce electrostatic adhesion and punch sticking; lubrication time is kept at 3–5 minutes because prolonged mixing can reduce tablet hardness. Moisture is held below 0.3% before dry granulation to limit compaction defects.
The primary constraint is blend segregation driven by differences in bulk density and particle size. With lactose monohydrate bulk density near 0.55 g/cm³ and vedaprofen bulk density in the range 0.35–0.55 g/cm³, turbulent transfer into tablet press feed frames can produce assay drift. Loss-on-drying data collected at 60 °C for 15 minutes indicate that residual moisture above 0.8% increases cohesiveness and die fill variability. For wet granulation, the API is first blended with maize starch and lactose, then granulated with 5–10% w/w polyvinylpyrrolidone solution in an FBS high-shear granulator at impeller speed 300–500 rpm; the wet mass is milled through a 1.0 mm screen and dried at 40–50 °C to final moisture ≤0.5%. Granule particle-size distribution is measured by sieve analysis per Ph. Eur. 2.9.12. Published data for vedaprofen direct compression is limited; the ranges above are starting points that require experimental confirmation under the intended production conditions.
Capsule formulations filled on dosator or tamping-pin machines require the same grade controls as tablets, but low API concentration in size 3 capsules may create flow variability when bulk density is below 0.35 g/cm³. Tamping-pin stations are typically operated at 40–80 cycles/min and adjusted to achieve fill weight RSD ≤2.0%. Precompression of slugged granulations improves flow but may reduce dissolution if the API remains hydrophobic; therefore, disintegrant selection and dissolution testing per Ph. Eur. 2.9.3 are required.
For injectable solutions, VP-I is dissolved in water for injection after pH adjustment with sodium hydroxide or meglumine. The resulting solution is commonly targeted to pH 7.4–8.0 because the free acid has low aqueous solubility below pH 6.0. Dissolution kinetics are size-dependent: a D50 ≤15 µm allows complete dissolution within 20 minutes in a paddle apparatus operated at 50 rpm in pH 7.2 phosphate buffer per Ph. Eur. 2.9.3. Terminal sterilization can be performed at 121 °C for 15 minutes if thermal stability data support it; otherwise, aseptic filtration through 0.2 µm polyethersulfone membrane is used. The API solution should be protected from light during compounding because naphthalene-containing propionic acids can undergo photodegradation.
Sterile filtration does not remove bacterial endotoxins; therefore, VP-I is subjected to endotoxin control during API manufacturing. The bacterial endotoxin limit is derived using the K/M expression in Ph. Eur. 5.1.10. For an intravenous product dosed at 1 mg/kg in a 500 kg horse, K = 5 EU/kg/h yields an endotoxin limit of ≤5 EU/mg when the full dose is 500 mg; the calculation must be repeated for the approved dose volume, route, and species. Total aerobic microbial count for VP-I is controlled at ≤10¹ CFU/g before terminal sterilization, and sterility testing is conducted per Ph. Eur. 2.6.1. Particulate matter is controlled after reconstitution or after dilution by light obscuration particle count test per Ph. Eur. 2.9.19, with limits for ≥10 µm and ≥25 µm particles as described in the monograph for parenteral preparations.
Premix and granulated feed applications use VP-PM, which is characterized by a D50 of 50–150 µm and bulk density 0.45–0.65 g/cm³. This grade is dry-mixed with lactose monohydrate or corn starch, then incorporated into a feed carrier at 0.1–1.0% w/w. Volumetric screw feeders maintain better feed rate control when the finished premix has minimal dusting and a compressibility index below 20%, calculated from poured and tapped density per Ph. Eur. 2.9.34. Blend uniformity is verified by HPLC assay after sampling from a ribbon blender at 10 locations; a relative standard deviation ≤5.0% and mean assay 90.0–110.0% of label claim are typical release criteria. Segregation from mineral carriers with bulk densities above 1.0 g/cm³ is minimized by matching particle size rather than by increasing over-mixing time.
Vedaprofen differs from flunixin meglumine and phenylbutazone in both chemical class and formulation behavior. Flunixin meglumine is an aminonicotinic acid derivative supplied as a meglumine salt with high aqueous solubility; vedaprofen is a propionic acid free acid requiring neutralization or micronization for aqueous solution work. Phenylbutazone is a pyrazolidinedione whose enolic tautomerism contributes to pH-dependent stability; vedaprofen lacks this equilibrium but remains sensitive to oxidation and photodegradation. Compared with carprofen, which contains a carbazole heterocycle, vedaprofen contains a cyclohexyl-substituted naphthalene ring; the molecular-weight difference and lipophilicity influence membrane permeability and extraction recoveries during HPLC assay development. These structural differences also mean that analytical methods, dissolution media, and residue withdrawal periods cannot be transferred from one NSAID to another. Species-specific pharmacokinetic data and residue depletion data for food-producing animals must be generated in the target formulation; published data for generic vedaprofen premix in minor species is limited.
Storage limits are set at ≤25 °C and ≤60% RH. At relative humidity above 60%, the API tends to agglomerate; pre-drying in a tray dryer at 40–50 °C for 6–12 h is recommended before dry blending. Contact with strong oxidizing agents should be avoided. Acid-base interaction with amine-based excipients may be intentional in solution manufacture but should be characterized in solid-state mixtures to avoid unexpected dissolution changes. Bulk API is packaged in double low-density polyethylene bags inside sealed HDPE drums; retest interval is typically 24–36 months when storage conditions are maintained. Long-term stability data support the retest period under ICH climatic zone II conditions of 25 °C/60% RH.
