| HS Code | 497923 |
| Product Name | Kanamycin Veterinary Grade API |
| Drug Category | Aminoglycoside Antibiotic |
| Available Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Api Grade | Veterinary Grade |
| Appearance | White or almost white crystalline powder |
| Solubility | Freely soluble in water, practically insoluble in organic solvents |
| Mechanism Of Action | Inhibits bacterial protein synthesis by binding to 30S ribosomal subunit |
| Spectrum | Broad-spectrum activity against Gram-negative and some Gram-positive bacteria |
| Indications | Treatment of bacterial infections such as colibacillosis, salmonellosis, and respiratory infections in livestock and poultry |
| Target Species | Cattle, pigs, sheep, goats, poultry, and other food-producing animals |
| Storage Conditions | Store in a cool, dry, well-ventilated place protected from light and moisture |
| Shelf Life | Typically 24 to 36 months when stored properly |
| Withdrawal Period | Varies by species and dosage form; observe mandatory slaughter and milk discard periods |
As an accredited Kanamycin 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 25kg net in double polythene-lined drums, sealed, labeled. Kanamycin veterinary grade API for tablets, injections, capsules, powders, granules, premix, solutions. |
| Container Loading (20′ FCL) | Kanamycin Veterinary Grade API loaded in 20’ FCL as palletized sealed drums/cartons, safely secured, climate-protected, with complete documentation for transport. |
| Shipping | Kanamycin Veterinary Grade API is shipped in sealed, light-resistant containers to prevent moisture and degradation. Shipments comply with international pharmaceutical transport regulations, with clear hazardous/non-hazardous labeling, temperature-controlled options available, and full documentation for veterinary use. Handle with care to maintain product integrity throughout transit. |
| Storage | Store in tightly sealed, light-resistant containers in a cool, dry, well-ventilated area at controlled room temperature. Protect from moisture, direct sunlight, and excessive heat. Keep away from acids, oxidizers, and incompatible materials. Ensure container remains closed when not in use. Follow manufacturer’s labeled storage conditions and expiry guidelines. |
| Shelf Life | Shelf life: 36 months when stored in original tightly closed containers, protected from light, in a cool, dry place. |
Compounding of a 100 mg/mL kanamycin active injectable solution for bovine respiratory disease and porcine colibacillosis begins with potency normalization of kanamycin sulfate assayed at 750 µg/mg as-is. A weighed quantity of 133.3 g/L kanamycin sulfate is dissolved in Water for Injection at 20–25 °C in a jacketed 316L stainless steel vessel with a bottom-mounted magnetic impeller operating at 120 rpm. The solution is sparged with nitrogen to maintain dissolved oxygen below 0.2 mg/L; sodium metabisulfite at 0.05% w/v is added only after oxygen displacement because oxidative conversion to sulfate causes visible haze in glass containers. Citrate buffer 0.02 M maintains pH at 6.3–6.8. pH above 7.0 accelerates high-pH darkening, while pH below 5.8 reduces aqueous solubility of minor kanamycin-related substances.
Terminal sterilization in a saturated steam autoclave at 116 °C for 30 min is used for containers validated for heat exposure; the cold-spot F0 is maintained between 8 and 12 min. Aseptic filtration through a 0.22 µm PVDF capsule filter followed by isolated aseptic filling in a closed restricted access barrier system is used when steam autoclaving causes pH shift outside the registered range. Potency loss after terminal sterilization should not exceed 3%, measured by HPLC with mobile phase containing trifluoroacetic acid and evaporative light scattering detection. The addition ratio expressed as 13.33% w/v kanamycin sulfate as-is corresponds to 10% w/v active base for a 100 mL fill. Terminal products include 50 mL, 100 mL, and 250 mL Type II glass vials with chlorobutyl stoppers; multi-dose formulations contain benzyl alcohol 0.9% v/v as preservative.
Compliance follows EU Regulation (EU) 2019/6 for veterinary medicinal product marketing authorisation, VICH GL18(R2) residual data for bovine and porcine edible tissues, and USP <71> sterility after fill. Endotoxin limits are 0.5 EU/mg per USP <85>. Preservative efficacy testing for multi-dose vials follows USP <51>. After filling, vials are leak-tested by high-voltage pinhole detection and incubated at 40 °C/75% RH for 14 days as an in-process stability indicator. The principal process conflict is oxygen ingress during compounding; nitrogen blanketing and restricted filling lines are therefore specified rather than open atmospheric transfer.
For broiler and layer flocks receiving water medication, a 50% w/w kanamycin sulfate water-soluble powder is pre-sieved through a 500 µm oscillating sieve, and lactose monohydrate is dehydrated to 0.5% moisture before charging a 500 L twin-shell V blender at 60% of total volume. The formulation consists of 50.0% w/w kanamycin sulfate as-is, anhydrous citric acid 5.0% w/w, malic acid 0.5% w/w, and lactose monohydrate q.s. to 100% w/w. Citric acid depresses local solution pH to 4.0–4.5 upon reconstitution, which reduces metal-catalyzed degradation and improves palatability. Blending is performed for 20 min at 15 rpm; longer blending increases fines and causes segregation of the denser API toward the blender shell. Dissolution performance is tested in 500 ppm CaCO₃ hard water at 20 °C; a completely clear solution must be achieved within 5 min with no visible particles larger than 50 µm.
After dry blending, a portion of the powder is converted to granules in a fluidized-bed granulator with top spray of purified water at inlet air 55–65 °C and product temperature 32–38 °C, until mean particle size reaches 250–850 µm. The granule form reduces dust, improves flow during automatic packing, and prevents stratification in multi-dose sachets. Compliance for this non-sterile powder is established under EU Regulation (EU) 2019/6 for medicated drinking water products and with the withdrawal period assigned for edible poultry tissues under Commission Regulation (EU) No 37/2010. Limits for aerobic microbial count and absence of Escherichia coli follow Ph. Eur. 5.1.4; water content is controlled below 0.8% by the Karl Fischer method USP <921>.
The addition ratio is 50.0% w/w kanamycin sulfate as-is in the dry blend. Terminal finished product types include 100 g, 500 g, and 1 kg foil-lined sachets and bulk 25 kg drums. Packaging is heat-sealed at 140 °C jaw temperature with dwell time 1.2 s. Reconstitution is field-limited by hard water alkalinity above 300 ppm CaCO₃, where pre-acidified water is recommended to maintain the prescribed pH window.
Uniform distribution of a 20% w/w kanamycin sulfate feed premix is governed less by blender speed than by carrier particle-size distribution and electrostatic charging. Ground corn cobs sieved to 500–1000 µm are sprayed with 0.5% w/w food-grade mineral oil in a twin-shaft paddle mixer at 35 rpm before API addition. Kanamycin sulfate as-is is pre-mixed with the same carrier at a 1:5 ratio by weight in a 100 L drum hoop mixer for 10 min; this geometric dilution step is repeated until a 1:25 intermediate is obtained. Final premix is mixed for 15 min with a coefficient of variation of ≤5% across 10 sampling points using HPLC assay. Addition ratios are presented as 20.0% w/w kanamycin sulfate, carrier q.s. to 100% w/w, and mineral oil 0.3–0.8% w/w. Final feed incorporation is calculated from the approved mg active per kg body weight dose; typical medicated feed levels do not exceed 80 ppm kanamycin activity in starter swine feeds, but published data for this specific configuration is limited and local marketing authorisation governs the exact permitted level.
Regulatory compliance is with Regulation (EU) 2019/4 on medicated feed and carryover prevention limits established by national authorities. Cleaning validation of the blender and transfer auger uses 100 L of a flushing diluent and an assay limit of ≤1% of active content in the following non-medicated batch. Particle-size analysis follows ISO 2591-1; bulk density is controlled between 0.45 and 0.60 g/cm³. Filling is conducted in a 25 °C, ≤40% RH area to prevent hygroscopic caking and electrostatic agglomeration. Terminal products include Type B finished feed and Type C additive premix packed in 25 kg three-ply paper bags with inner PE liner.
When kanamycin sulfate is compacted into 20 mg and 50 mg companion-animal tablets, wet granulation rather than direct compression is selected because the API has poor powder flow and a bitter taste. The tablet core formula includes kanamycin sulfate equivalent to 20 mg active per 250 mg target core weight, an addition ratio of 8.0% w/w active base, or approximately 10.7% w/w kanamycin sulfate as-is at 750 µg/mg. Polyvinylpyrrolidone K30 4.0% w/w is dissolved in a 2-propanol/water (15:85) mixture and used as binder. Crospovidone 2.0% w/w is split intragranular and extragranular to control disintegration. Microcrystalline cellulose 35.0% w/w, lactose monohydrate q.s. to 100% w/w, and magnesium stearate 0.75% w/w complete the core.
Granulation is performed in a 300 L high-shear mixer-granulator with impeller at 250 rpm and chopper at 1500 rpm; wet mass moisture is held at 14–16% w/w. Drying in a fluid-bed dryer at inlet air 55–65 °C proceeds to loss on drying ≤2.0%. Milling through a 1.0 mm screen is followed by tableting on a 27-station rotary press with compression force 18–22 kN, target hardness 7–10 kp, and friability ≤0.5% per USP <1216>. Tablets are film-coated with 3.0% w/w ethylcellulose/HPMC barrier for taste masking. Quality release includes USP <905> uniformity of dosage units, USP <711> dissolution in 0.1 M HCl at 37 °C paddle 50 rpm with Q 80% in 45 min, and USP <701> disintegration ≤15 min.
Terminal finished product types include 20 mg and 50 mg film-coated tablets in aluminum/PVC cold-form blisters. A 25 mg active capsule is filled on an automatic dosator capsule machine with fill weight 120 mg; the addition ratio in capsules is 20.8% w/w active base after potency adjustment. Because kanamycin sulfate is hygroscopic, granulation and compression areas are maintained at ≤40% RH, and bulk intermediate storage is limited to 24 h before final packaging.
In postpartum metritis therapy for dairy cows, a 50 mL intrauterine kanamycin sulfate solution is compounded as a single-dose product because acidic vaginal transudates and tissue debris can chelate aminoglycosides. The formulation uses 5 mg/mL kanamycin activity, equivalent to 6.7 mg/mL kanamycin sulfate as-is at 750 µg/mg. Dilution is performed in Water for Injection with methylparaben 0.1% w/v and propylparaben 0.01% w/v as preservative; the solution is adjusted to pH 6.0–6.5 with dilute sulfuric acid. The addition ratio is 0.67% w/v kanamycin sulfate as-is, below the solubility limit by an order of magnitude, reducing the risk of recrystallization during cold-chain transport at 2–8 °C.
Filtration through a 0.22 µm PVDF membrane is followed by aseptic filling into pre-sterilized 50 mL high-density polyethylene intrauterine syringes with a 5 cm flex cannula. Terminal sterilization by gamma irradiation is generally avoided because ionizing radiation can produce radiolytic degradation products and darken aminoglycoside solutions; aseptic filling is therefore the preferred route. Published data for this specific configuration is limited; process validation must include media fills with 5000 units per shift and USP <71> sterility on finished product. Compliance includes EU Regulation (EU) 2019/6, VICH GL18(R2), and Ph. Eur. 5.1.1 sterility for aseptically filled veterinary medicines. Withdrawal periods for milk and meat follow the EU MRL entry in Commission Regulation (EU) No 37/2010.
The terminal finished product is a single-dose disposable intrauterine catheter syringe; secondary packaging is a polyester/aluminum peel pouch. Retention time in the uterus is influenced by formulation pH, but field data on process-scale fill accuracy for this container type remain limited; fill-weight checks are specified at ±2% deviation and no more than 1 leak unit per 10,000 filled syringes.
| Dosage form | Compliance anchors | Formulation addition ratio | Critical process limit | Terminal product |
|---|---|---|---|---|
| Parenteral solution | EU 2019/6, USP <71>, USP <85>, VICH GL18(R2) | 13.33% w/v kanamycin sulfate as-is | pH 6.3–6.8; F0 8–12 min | 50–250 mL Type II glass vials |
| Drinking-water powder/granule | EU 2019/6, EU 37/2010, Ph. Eur. 5.1.4, USP <921> | 50.0% w/w kanamycin sulfate as-is | Reconstitution ≤5 min; water content ≤0.8% | 100 g–25 kg sachets/drums |
| Feed premix | EU 2019/4, ISO 2591-1 | 20.0% w/w kanamycin sulfate as-is | CV ≤5%; bulk density 0.45–0.60 g/cm³ | 25 kg paper/PE bags, Type C premix |
| Tablet/capsule | USP <905>, USP <711>, USP <701>, USP <1216> | 8.0% w/w active in tablet core; 20.8% w/w active in capsule fill | LOD ≤2.0%; disintegration ≤15 min | 20–50 mg tablets; 25 mg capsules |
| Intrauterine solution | EU 2019/6, VICH GL18(R2), Ph. Eur. 5.1.1 | 0.67% w/v kanamycin sulfate as-is | pH 6.0–6.5; fill weight ±2% | 50 mL single-dose intrauterine syringe |
Competitive Kanamycin 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!
Kanamycin Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is the compendial sulfate salt of kanamycin A obtained by fermentation of Streptomyces kanamyceticus and purified by cation-exchange chromatography, nanofiltration, and spray drying. The grade designation is Kanamycin Sulfate, Veterinary API, multicompendial USP/Ph. Eur., with a lower potency acceptance limit of 750 µg/mg on the dried basis. The anhydrous molecular formula is C18H36N4O11·H2SO4, corresponding to a molecular weight of 582.58 g/mol. The material is a white to off-white crystalline powder with high aqueous solubility, allowing the same sulfate salt to be distributed across tablet granulation, hard capsule filling, powder and granule sachets, medicated premix, oral solution, and sterile injection manufacture. Kanamycin A is the principal active component, while kanamycin B and related aminoglycoside impurities are controlled by HPLC against the current pharmacopoeial reference standard. The sulfate counterion content is maintained between 15.0% and 17.0%, distinguishing the salt from kanamycin base and influencing stoichiometric adjustment in salt-conversion formulations. The fermentation-derived impurity profile differs from semisynthetic aminoglycosides such as amikacin, which is derived from kanamycin A but carries a 2-hydroxy-4-aminobutyric acid side chain; that structural difference alters susceptibility to aminoglycoside-modifying enzymes and should not be assumed equivalent in veterinary formularies.
The sulfate salt is produced by acidification of purified kanamycin base with sulfuric acid followed by crystallization from aqueous ethanol. This process influences residual solvent profile, particle morphology, and bulk handling. The powder is classified or spray-dried for oral dosage forms and premix, while granular grades are used for direct compression and sachet filling. Because kanamycin is a polar, multicationic molecule at physiological pH, its diffusion across lipid membranes is limited; this property explains its use as a gastrointestinal or parenteral aminoglycoside rather than a transdermal or intracellular antibacterial agent.
Release testing follows the pharmacopoeial monographs for kanamycin sulfate. The specification table below is applied to non-sterile veterinary API for subsequent formulation into oral and injectable dosage forms. Injectable-grade material requires additional finished-product controls for bacterial endotoxins and sterility because the non-sterile API itself is not an aseptic-grade input. HPLC procedures for related substances are selected because kanamycin has no strong chromophore; pre-column derivatization with 2,4,6-trinitrobenzenesulfonic acid or charged aerosol detection is used to reach quantification limits below the monograph threshold.
| Parameter | Acceptance range or criterion | Reference procedure |
|---|---|---|
| Identification | HPLC retention time and detector profile correspond to kanamycin sulfate reference standard | USP <621> / Ph. Eur. 2.2.29 |
| Potency | ≥ 750 µg/mg dried basis | USP <81> or validated HPLC |
| pH of 1% aqueous solution | 6.5–8.5 | USP <791> / Ph. Eur. 2.2.3 |
| Specific optical rotation | +112° to +123° on dried basis | USP <781> / Ph. Eur. 2.2.7 |
| Loss on drying | ≤ 1.5% | USP <731> / Ph. Eur. 2.2.32 |
| Sulfate content | 15.0%–17.0% | compendial titrimetric sulfate determination |
| Residual solvents | Class 3 solvents ≤ 0.5% individually unless otherwise justified | USP <467> / Ph. Eur. 5.4 |
| Related substances | Kanamycin B and other related aminoglycosides within monograph-defined limits | HPLC with pre-column derivatization or charged aerosol detection |
| Elemental impurities | Limits according to ICH Q3D for oral or parenteral route | USP <233> |
| Bulk density | Lot-specific control range established during process validation | USP <616> |
Because low-chromophore detection platforms produce related-substance profiles that can vary between multi-source API when methods are not aligned, comparison of suppliers should be performed with the same derivatization chemistry and a common reference standard. Potency can be determined by microbiological assay according to USP <81> or by stability-indicating HPLC; microbiological assay remains the compendial referee method for disputed results. For medicated premix and granule applications, particle-size distribution is an additional release parameter. Laser diffraction per USP <429> typically controls the D90 below 250 µm for oral powder grades, while a spray-dried granular grade may be controlled at 150–850 µm. Bulk density and tapped density are measured by USP <616> to anticipate flow behavior in roller compaction and encapsulation. The powder generally exhibits a Carr compressibility index below 25% after milling and drying; values above 30% indicate poor flow and require glidant addition.
Across oral solid dosage lines, kanamycin sulfate is processed with a preference for dry granulation by roller compaction when moisture-sensitive formulations are required. In wet granulation with a high-shear granulator, the API is dissolved in the aqueous binder and sprayed onto a lactose monohydrate or mannitol carrier. Dryer inlet air is held between 45°C and 55°C; inlet temperatures above 60°C have been associated with color development and potency drift on production-scale fluid-bed dryers. Final granule moisture is controlled between 1.0% and 3.0%, with outlet relative humidity below 40%, to prevent die-fill variability and punch filming on rotary tablet presses. Direct compression of kanamycin sulfate powder is possible only when the API particle size is matched to the filler; otherwise segregation occurs during hopper discharge. Tablet hardness is adjusted to 80–120 N when tested by USP <1217>, with friability below 1.0% by USP <1216>. For capsule filling, the powder blend is lubricated with magnesium stearate at a concentration not exceeding 0.5% to avoid delayed dissolution; capsule blend uniformity is confirmed by HPLC with an acceptance of not more than 5.0% relative standard deviation across ten sampling points.
Injection-grade evaluations include bacterial endotoxin testing by USP <85> at the finished-product level; the API itself may be non-sterile. The sulfate salt is dissolved in Water for Injection at 20–25°C, and the solution is buffered with citrate or phosphate to pH 6.5–7.5. Alkaline hydrolysis is more rapid than acid hydrolysis; pH excursions above 8.0 are specifically avoided during compounding and terminal sterilization. Sterile filtration through 0.22 µm polyvinylidene fluoride membranes is standard for aseptic manufacture. Terminal steam sterilization at 121°C for 15 minutes may be acceptable only after formulation-specific stability data demonstrate no degradation above the specification threshold. Aminoglycoside solutions should not be autoclaved with dextrose or other reducing sugars unless compatibility studies are available because Maillard-type degradation can produce colored products.
In medicated feed and premix operations, kanamycin sulfate is incorporated at active inclusion rates of 50–500 g/tonne for target species when local marketing authorization permits. Direct addition of high-potency API to final feed is not performed because pneumatic conveying and vibrating belt transfer cause electrostatic segregation of the crystalline powder. Stepwise geometric dilution is used: the API is first blended with calcium carbonate or lactose monohydrate at a ratio of 1:10, then 1:100, followed by final ribbon blending in a horizontal mixer. Blend uniformity is verified with ten sampling locations using a dry powder sampling thief and HPLC assay; the acceptance value for uniformity of dosage units is not more than 15.0 according to USP <905>. Segregation potential is assessed by drop testing and transfer through a bucket elevator; potency drift beyond ±10% of target indicates particle-size mismatch between API and carrier. Granule premix forms are produced by low-shear extrusion-spheronization to pellets with a diameter of 1.0–1.5 mm, which reduces fugitive dust but requires drying at product temperature not exceeding 60°C.
Selection among aminoglycosides is determined by target pathogen susceptibility, route of administration, and systemic safety margin. Kanamycin sulfate differs from gentamicin sulfate in its lower activity against Pseudomonas aeruginosa; gentamicin is generally preferred for systemic infections in dogs and horses where Pseudomonas is documented, whereas kanamycin is used in enteric and respiratory formulations for cattle, swine, and poultry when susceptible Escherichia coli and Salmonella enterica are the primary targets. Compared with neomycin sulfate, kanamycin sulfate is more frequently used in injectable formulations because neomycin is largely restricted to topical and enteric use due to systemic oto/nephrotoxicity. Resistance mechanisms also differ: kanamycin and neomycin share cross-resistance through APH(3′)-Ia/Ib enzymes, while gentamicin is affected by AAC(6′)-I and AAC(3) enzymes. Veterinary diagnostic laboratories that report aminoglycoside phenotype rather than gene-specific resistance therefore require separate interpretation for kanamycin and gentamicin. In feed mills, kanamycin sulfate also differs from zinc bacitracin and tetracycline premixes in its narrow Gram-negative spectrum and pH-dependent carryover behavior; cleaning validation for kanamycin-containing premix lines should use HPLC rinse samples with a residue acceptance limit derived from the permitted daily exposure rather than visual inspection alone.
For purchasing specifications, the veterinary API should be requested as kanamycin sulfate, USP/Ph. Eur. grade, with a stated potency basis and residual solvent statement. Multi-source substitution without equivalence testing is not advisable because particle size, bulk density, and related-substance profiles can affect blend uniformity and dissolution. A supplier change requires process performance qualification on the relevant production line; this is particularly relevant for low-dose premix applications where carrier uptake capacity can shift with API surface area.
Because the sulfate salt is hygroscopic, storage in unopened compendial containers should be maintained at 15–25°C and protected from light; open containers are re-sealed with desiccant when ambient relative humidity exceeds 60%. Extended exposure to humidity leads to caking and can alter flowability before measurable potency loss occurs. Kanamycin sulfate is incompatible in aqueous solution with beta-lactam antibiotics, particularly penicillins and cephalosporins, through nucleophilic opening of the beta-lactam ring by the aminoglycoside amine groups; mixed parenteral fluids should not be prepared unless stability-indicating HPLC demonstrates compatibility. Strongly alkaline buffers and polyionic excipients such as sodium alginate may complex or precipitate the cationic drug. For oral multi-dose solutions, dilution with chlorinated water can generate chloramine by-products; assay verification is required before field use. The primary operational boundary for tablets and capsules is moisture. Granule moisture above 3.0% can cause tablet capping and capsule shell embrittlement; moisture below 1.0% increases electrostatic adhesion to stainless steel and acrylic equipment surfaces. For injection compounding, the maximum holding time for aqueous solutions at 2–8°C should be established by stability data; unpreserved solutions are at risk of microbial proliferation and should be used within a single working day when not terminally sterilized. Kanamycin sulfate is not compatible with strong oxidizing agents used in cleanroom disinfection; direct contact with sodium hypochlorite can produce degradation products and should be avoided. Regulatory status for food-producing species varies by jurisdiction; finished-product approvals define species, dose, route, and withdrawal period, and the veterinary API itself is not directly administered to animals.
