| HS Code | 270859 |
| Product Name | Neomycin sulphate Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Api Substance | Neomycin Sulphate |
| Grade | Pharma Grade |
| Dosage Forms | Tablet, Capsule, Granule, Injection |
| Routes Of Administration | Oral and Injectable |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water; slightly soluble in alcohol; practically insoluble in acetone and ether |
| Identification | Positive for neomycin by IR, HPLC retention time, and sulphate test |
| Assay Method | Microbiological assay or validated HPLC method |
| Ph | 5.0 to 7.5 for aqueous solution |
| Bacterial Endotoxins | Meets pharmacopoeial specification for injectable use |
| Storage | Store in a well-closed container, protected from moisture and light |
As an accredited Neomycin sulphate Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Neomycin sulphate Pharma Grade API: 25 kg/drum, double polythene-lined, for tablet, capsule, granule, injection, oral and injectable use. |
| Container Loading (20′ FCL) | 20′ FCL containing palletized drums of Neomycin sulphate (Pharma Grade API), safely loaded for oral/injectable formulations, with secure, dry, contamination-free transport. |
| Shipping | Neomycin sulphate Pharma Grade API ships in sealed, inert containers to prevent contamination and moisture ingress. Transport under controlled ambient temperature, away from light and incompatible substances. Compliance with IATA/IMDG dangerous goods regulations is required for air or sea freight. Ensure tamper-evident packaging for oral and injectable powder delivery. |
| Storage | Store Neomycin Sulphate Pharma Grade API in tightly sealed, original containers under dry, well-ventilated conditions. Protect from light, moisture, and excessive heat; recommended storage below 25°C. Avoid contact with oxidizing agents. Maintain inventory rotation to prevent degradation. For oral, injectable, tablet, capsule, and granule formulations, ensure compliance with pharmacopoeial standards throughout shelf life. |
| Shelf Life | Shelf life: 36 months from date of manufacture when stored in tightly closed containers, away from light, moisture, and heat. |
In high-dose oral tablet manufacturing for preoperative intestinal antisepsis and adjunctive hepatic encephalopathy therapy, neomycin sulfate is formulated around a compendial input calculation rather than a fixed weight percent. A typical lot assays at 630 µg/mg neomycin base on a dried basis, so a 500 mg base claim requires 793.7 mg of dried neomycin sulfate per unit. After applying a loss-on-drying correction of 1.0–1.5% per USP <731>, the as-is API addition commonly falls between 77 wt% and 82 wt% of a 970–1030 mg uncoated tablet core. The formulation is built with intragranular crospovidone at 2–5 wt%, povidone K30 binder solution at 5% w/w, microcrystalline cellulose as diluent, and magnesium stearate at 0.5–1.0 wt% for lubrication. Granulation is performed in a top-driven high-shear mixer with impeller speed 150 rpm and chopper speed 1500 rpm; binder solution is metered at 2–4 kg/min to a wet mass endpoint judged by impeller power rise, typically 3–6 min after binder addition. The wet mass is passed through a 1.6–2.0 mm conical mill and dried in a fluid-bed dryer with inlet air 55–65°C and product temperature 30–35°C until the granule loss on drying is ≤1.5%. Dried granules are milled through a 0.8–1.4 mm screen, blended in a 600 L bin blender at 10–15 rpm for 15–20 min, and compressed on a rotary tablet press with main compression force 12–20 kN and turret speed 30–50 rpm. Tablet hardness is maintained at 80–120 N; friability remains ≤1.0% per USP <1216>, disintegration time is NMT 15 min per USP <701>, and content uniformity meets USP <905> acceptance value ≤15. Elemental impurity control follows ICH Q3D, with oral permitted daily exposure limits applied to the sulfate salt. Terminal product types include immediate-release film-coated and uncoated round biconvex tablets at 500 mg base, packaged in HDPE bottles with molecular sieve or silica gel desiccant because the sulfate salt becomes tacky above 60% RH.
Dry granulation is selected for low-fill-weight capsules because direct compression of neomycin sulfate at a 250 mg base claim produces unacceptable flow segregation and fill-weight drift. At a batch potency of 620 µg/mg, the 250 mg dose requires 403.2 mg of API per unit, which approaches the upper fill limit of a size 0 hard gelatin capsule once granulated excipients are included. Roller compaction converts the poorly flowing API into a densified granulate with bulk density 0.55–0.65 g/mL and improved mass flow, enabling fill weight 430–460 mg per size 0 capsule and API proportion 88–94 wt%. The dry granulation line uses a roller compactor with roll pressure 4–8 MPa, roll gap 1.5–2.5 mm, and milling screen 1.0–1.5 mm; the resulting granules are blended with croscarmellose sodium at 2–4 wt% and magnesium stearate at 0.5–1.0 wt% in a 300 L bin blender at 12–20 rpm for 15 min. Encapsulation runs on a dosing-disc capsule filling machine at 60,000–100,000 capsules/h with tamping pin pressure adjusted to achieve weight variation ±5% for a 450 mg fill. Quality control includes USP <905> uniformity of dosage units, dissolution testing per USP <711> using a validated immediate-release capsule method such as 900 mL deaerated water at 37°C with basket apparatus at 100 rpm, and microbial enumeration per USP <61> and USP <62>. Terminal product types are printed hard gelatin or HPMC capsules containing 250 mg neomycin base, intended for divided oral dosing in adult patients requiring intestinal decontamination; the printed surface aids dose differentiation when multiple aminoglycoside products are stocked on hospital formulary shelves.
When a 970–1030 mg tablet is not acceptable for geriatric or pediatric patients and dose flexibility is required before surgery, single-dose oral granules are manufactured as a different downstream format. A 500 mg base sachet uses the same dried-basis input calculation as the tablet: at 650 µg/mg potency, 769.2 mg of neomycin sulfate is weighed, then converted to as-is basis using a Karl Fischer or loss-on-drying value. The granulation vehicle is an aqueous povidone K30 solution at 5% w/w sprayed in a top-spray fluid-bed granulator such as a GPCG 30 with inlet air 60–70°C, product bed temperature 28–34°C, spray rate 80–150 g/min, and atomizing air pressure 2.5 bar. Dried granules are screened between 180 µm and 850 µm; oversized and undersized fractions are milled and recirculated. The final sachet blend contains the granulated API at 38–40 wt% of a 2000 mg total fill, with direct-compressible sucrose or sorbitol as bulk sweetener, sodium saccharin at 0.2–0.5 wt%, and a dry flavor at 0.3–1.0 wt%. Vertical form-fill-seal packaging produces single-dose sachets at 60–80 strokes/min with fill-weight tolerance ±3% and seal-strength testing per ASTM F88. Compliance requires particle-size distribution by USP <786>, uniformity of dosage units per Ph. Eur. 2.9.40, moisture content by USP <921>, microbial limits per USP <61> and USP <62>, and elemental impurity control per ICH Q3D. Terminal product types are unit-dose sachets labelled as granules for oral suspension or sprinkle administration, with a dose of 500 mg neomycin base per sachet; the granules are dispersed in water or soft food immediately before administration to minimize hygroscopic clumping in humid environments.
Parenteral neomycin sulfate injection is manufactured as an aseptically filtered aqueous solution because terminal steam sterilisation at 121°C accelerates aminoglycoside degradation and discolouration, and because the clinical use is restricted to intramuscular administration for serious Gram-negative infections when less nephrotoxic and ototoxic alternatives cannot be used. The solution is prepared at 50–100 mg neomycin base per mL in Water for Injection, adjusted to pH 5.0–7.0 with 0.1 N sulfuric acid or sodium hydroxide, and filled into 2 mL or 5 mL single-dose Type I glass vials. A 2 mL vial filled at 100 mg/mL delivers 200 mg neomycin base; the fill volume tolerance is ±0.05 mL for a 2 mL volume. Sterile filtration is performed through a 0.22 µm PVDF membrane in an ISO 14644-1 Class 5 environment within an ISO Class 7 background, with filling and stopper placement executed on an aseptic filling line operating at 100–200 vials/min. Release testing includes USP <71> sterility, USP <85> bacterial endotoxins with a limit calculated as K/M where K is 5 EU/kg and M is the maximum bolus dose per kg per hour; for a 5 mg/kg single intramuscular dose the limit is 1 EU/mg, and divided regimens tighten the limit accordingly. Particulate matter is controlled per USP <788>, and aseptic process simulation follows 21 CFR 211.167 and relevant PIC/S Annex 1 principles. The label restricts administration to deep intramuscular injection; intravenous use is contraindicated because rapid serum concentrations are associated with neuromuscular blockade and acute renal tubule necrosis. Terminal product types are sterile aqueous injection presentations at 200 mg/2 mL or 500 mg/5 mL, stored at controlled room temperature but protected from light.
For distribution channels without guaranteed cold-chain storage and for solution stability profiles showing sulphate-related colour formation after 18–24 months at 25°C, lyophilised neomycin sulfate injection is produced as a shelf-stable alternative. The pre-lyophilisation bulk is compounded at 50 mg/mL neomycin base with 20–25 mg/mL mannitol as a crystalline bulking agent and Water for Injection to a total solids content of 7.0–7.5% w/v; a 10 mL fill into a 20 mL Type I glass vial provides 500 mg neomycin base per unit. The solution is sterile-filtered through 0.22 µm PVDF and filled in an ISO Class 5 environment before entering the freeze-dryer. A typical industrial lyophilisation cycle for this presentation freezes the shelf from 5°C to -45°C over 6 h, holds for 3 h, then performs primary drying at a shelf temperature of -20°C and chamber pressure 0.15–0.25 mbar for 48–72 h. Secondary drying runs at 25–30°C and 0.05–0.10 mbar for 12–24 h, with residual moisture controlled by USP <921> Karl Fischer titration to ≤2.0%. Release testing includes USP <71>, USP <85>, USP <788>, and container closure integrity per USP <1207>. The terminal presentations are sterile lyophilised cakes in single-dose Type I glass vials sealed with bromobutyl rubber stoppers and aluminium flip-off seals, reconstituted with Sterile Water for Injection to 100 mg/mL immediately before deep intramuscular use. Published industrial cycle parameters for this specific configuration are limited because neomycin sulfate lyophilisation is not a high-volume monograph product; the ranges above represent validated parenteral aminoglycoside freeze-drying practice rather than a compendial specification.
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Neomycin sulphate Pharma Grade API, a fermentation-derived aminoglycoside antibiotic obtained from Streptomyces fradiae, is supplied as a white to off-white hygroscopic powder with route-specific release variants: oral solid-dose, granule, and sterile non-pyrogenic injectable grades. The product model is defined by the grade designation rather than a single catalogue number because the injectable variant carries additional endotoxin, particulate, and sterility specifications that cannot be retroactively applied to oral material. The material conforms to the current USP–NF Neomycin Sulfate monograph and the Ph. Eur. monograph for neomycini sulfas; compendial potency is not less than 600 µg/mg of neomycin on the dried basis. Unlike feed-grade neomycin sulphate, which may be released without full pharmacopoeial impurity profiling and under less stringent storage conditions, the pharma grade API is manufactured under ICH Q7 requirements for active pharmaceutical ingredients, with residual solvents controlled per ICH Q3C, microbial enumeration and specified organisms per USP <61> and USP <62>, and bacterial endotoxins per USP <85> for the injectable variant. The powder is freely soluble in water; an aqueous solution at 100 mg/mL is typically clear and falls within a pH range of 4.5–7.5. Related substances include neamine, which is resolved by ion-pairing HPLC and reported as area percent against the active peak.
| Grade designation | Primary route | Endotoxin limit | Loss on drying | Particle size control | Packaging configuration |
|---|---|---|---|---|---|
| Oral solid-dose | Tablet, capsule | Not specified | ≤8.0% typical | D90 ≤100 µm | Double LDPE liner in fibre drum |
| Granule | Oral sachet | Not specified | ≤2.0% final granule moisture | 150–850 µm | Aluminium foil laminate sachet |
| Injectable | Injection, intravenous infusion | ≤0.5 EU/mg typical | ≤8.0% typical | Particulate matter per harmonised pharmacopoeial limits | Cleanroom double-bagged, tamper-evident aluminium-laminate outer |
Injectable-grade neomycin sulphate is released only after bacterial endotoxin testing by the kinetic chromogenic method of USP <85>; a typical release target is ≤0.5 EU/mg, with the finished-product limit derived from the maximum dose administered per kilogram of body weight. The larger manufacturing constraint is thermal degradation: aqueous neomycin sulphate solutions cannot be terminally sterilised by steam at 121 °C for 15 minutes without measurable potency loss, so the API is processed by aseptic membrane filtration through a 0.22 µm polyvinylidene fluoride or polyethersulfone filter in an ISO 14644-1 Class 5 environment. Equipment cleaning and sanitization are validated under 21 CFR 211.67, and filter integrity is tested by bubble point or forward-flow diffusion before and after each batch. Endotoxin removal for injectable grade is performed upstream by ultrafiltration or activated carbon adsorption; carbon adsorption introduces a process conflict because the cationic neomycin molecule binds to carboxyl-rich activated carbon surfaces, lowering yield and creating batch-to-batch potency variation if contact time exceeds the validated limit. Published data for this specific configuration is limited, and manufacturers therefore establish a maximum carbon contact time rather than a fixed carbon dose.
Parenteral use is further constrained by the narrow therapeutic index of neomycin: nephrotoxicity and ototoxicity are dose-dependent and restrict the injectable route to situations where less toxic aminoglycosides are not indicated. Formulation pH must be maintained between 4.5 and 7.5 because alkaline conditions accelerate pseudo-first-order hydrolysis of the glycosidic linkages. Neomycin sulphate is incompatible with beta-lactam antibiotics such as penicillin G when mixed in the same infusion container; the primary amine groups open the beta-lactam ring, forming inactive amide complexes at rates that increase with temperature and concentration. For intravenous infusion, 0.9% sodium chloride is preferred over dextrose-containing diluents because reducing sugars can engage the primary amines of the aminoglycoside in Maillard-type adduct formation, although published kinetic data for neomycin in dextrose infusion bags is limited. These constraints explain why the injectable grade is manufactured in small batch sizes with dedicated equipment and why the pharmacopoeial monograph requires tight control of particulate matter and visible foreign particles.
On rotary tablet presses with punch diameters from 8 mm to 13 mm, the hygroscopic nature of neomycin sulphate becomes the primary process variable. Direct compression is feasible only when ambient relative humidity is held below 40%; above this threshold, the powder bed absorbs moisture, the flow function coefficient drops below 3.0, and the material adheres to unlubricated tooling. A micronized oral solid-dose grade is specified with a laser-diffraction particle size D90 of ≤100 µm per USP <429> to support content uniformity in low-dose tablets; smaller particles improve blend homogeneity but increase the surface area available for moisture uptake. The standard blend includes colloidal silicon dioxide at 0.5–2.0 wt% and magnesium stearate at 0.5–1.0 wt%, lubricated for 3–5 minutes in a V-blender to avoid excessive shear. Hard gelatin capsule filling requires no granulation when the granule grade is pre-screened through a 30-mesh sieve. When tablet manufacture is performed by high-shear wet granulation, purified water is the binder solvent, and the wet mass is dried in a fluid-bed dryer with inlet air temperature not exceeding 45 °C because neomycin sulphate is heat-sensitive in the presence of moisture. Final granule moisture is maintained at ≤2.0% by loss on drying before compression to prevent punch filming and die-wall scraping. Content uniformity is verified by USP <905>, and dissolution is evaluated by USP <711> using 0.1 M hydrochloric acid as the medium for immediate-release tablets; the acceptance criterion follows the pharmacopoeial Q value for immediate-release dosage forms. Published data for neomycin tablet dissolution under biorelevant conditions is limited, so the compendial method remains the release test.
Oral granules of neomycin sulphate are used for pre-operative intestinal antisepsis and for reduction of ammonia-producing colonic flora in hepatic encephalopathy, with adult dosing commonly cited from 4–12 g/day in divided administrations. Replacement of feed-grade neomycin sulphate with pharma-grade API alters granule design at three points: impurity control, potency uniformity, and packaging stability. Feed-grade material may contain higher levels of neamine and uncharacterised fermentation by-products because release testing is not harmonised with compendial monographs; pharma-grade material is released with related-substance profiling by ion-pairing HPLC, so the granule formulator can assign a fixed label claim without potency overage. Wet granulation with povidone K30 at 3–5 wt% is common; the binder solution is prepared at 10% w/w solids and added at a rate that maintains granule size distribution within 150–850 µm for sachet filling. After fluid-bed drying at inlet air temperatures not exceeding 45 °C, the granules are screened through a 20-mesh screen and packed into aluminium foil laminate sachets with a moisture vapour transmission rate below 0.1 g/m²/day because neomycin sulphate granules caked at accelerated humidity conditions above 40% RH. Taste masking is mandatory for oral granules; a hydroxypropyl methylcellulose film coat at 3–5 wt% coating weight is applied in a bottom-spray fluid-bed coater. Paediatric and geriatric dose adjustments are governed by the finished-product label, not by the API specification, and published palatability data for neomycin oral granules is limited.
Neomycin sulphate differs from gentamicin sulphate, streptomycin sulphate, and kanamycin sulphate in source organism, spectrum, and compendial impurity profile. The matrix below summarises route-relevant differences; potency values are expressed on the dried basis where the monograph defines them.
| Parameter | Neomycin sulphate | Gentamicin sulphate | Streptomycin sulphate | Kanamycin sulphate |
|---|---|---|---|---|
| Source organism | Streptomyces fradiae | Micromonospora purpurea | Streptomyces griseus | Streptomyces kanamyceticus |
| Compendial monograph | USP–NF Neomycin Sulfate, Ph. Eur. Neomycini sulfas | USP–NF Gentamicin Sulfate, Ph. Eur. | USP–NF Streptomycin Sulfate, Ph. Eur. | USP–NF Kanamycin Sulfate, Ph. Eur. |
| Compendial potency basis | Not less than 600 µg/mg on dried basis | Expressed as µg/mg on dried basis | Expressed as µg/mg or IU/mg on dried basis | Expressed as µg/mg on dried basis |
| Primary route emphasis | Oral, topical, limited injectable | Injectable, topical | Injectable | Injectable, oral |
| Specified impurity/control | Neamine | Gentamicin C complex ratio | Streptidine | Kanamycin B |
| Injectable endotoxin control | USP <85>, typical ≤0.5 EU/mg | USP <85> | USP <85> | USP <85> |
Release under current good manufacturing practice requires the API manufacturer to maintain a Site Master File that aligns with ICH Q7 and to provide the finished-dose manufacturer with a certificate of analysis reporting every specification parameter, including identity by infrared absorption spectrophotometry against a reference standard, assay by HPLC or microbiological agar diffusion, related substances, loss on drying, residue on ignition, heavy metals or individual metal catalysts, residual solvents by headspace GC according to ICH Q3C, and microbial limits. The oral solid-dose grade is packaged in double low-density polyethylene liners inside a fibre drum; the injectable grade is double-bagged and sealed in a cleanroom before placement in a tamper-evident aluminium-laminate outer container. Storage at controlled room temperature, defined as 20–25 °C, in a tightly closed, light-resistant container is standard; excursions above 40% RH during sampling should be minimised because the opened container adsorbs moisture and can increase loss on drying above the release limit. The manufacturer assigns a retest date based on long-term stability data generated under ICH Q1A; typical retest intervals are 24–36 months from release, but published data for this specific configuration is limited.
