| HS Code | 429171 |
| Product Name | Streptomycin Sulphate Pharma Grade API |
| Antibiotic Class | Aminoglycoside antibiotic |
| Dosage Forms | Tablet, Capsule, Granule, Injection |
| Route Of Administration | Oral and Injectable |
| Cas Number | 3810-74-0 |
| Molecular Formula | (C21H39N7O12)2·3H2SO4 |
| Molecular Weight | 1457.38 g/mol |
| Appearance | White or almost white crystalline hygroscopic powder |
| Solubility | Freely soluble in water; very slightly soluble in ethanol; practically insoluble in ether and chloroform |
| Assay Content | 98.0% to 102.0% on dried basis |
| Ph Range | 4.5 to 7.0 in aqueous solution |
| Storage Conditions | Keep in tightly closed, moisture-proof containers; protect from light; store at controlled room temperature |
As an accredited Streptomycin 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 | Packaging: 25 kg HDPE drums, double polyethylene lined, containing Streptomycin Sulphate Pharma Grade API for oral and injectable use. |
| Container Loading (20′ FCL) | 20′ FCL loading of Streptomycin sulphate API in sealed drums/pallets, ensuring safe, contamination-free transport for oral and injectable pharmaceutical use. |
| Shipping | Streptomycin sulphate Pharma Grade API is shipped in sealed, moisture-proof containers to maintain sterility and stability. Shipments require temperature-controlled, dry conditions, protected from light. Handling follows pharmaceutical safety protocols. Documentation includes MSDS, certificate of analysis, and regulatory compliance for oral and injectable grade material. |
| Storage | Store in a cool, dry, well-ventilated area at controlled room temperature (15–30°C), away from direct sunlight, moisture, and incompatible substances. Keep the container tightly closed and protected from humidity. Avoid excessive heat. Ensure proper labeling and segregate from foodstuffs. Use suitable personal protective equipment when handling. |
| Shelf Life | Shelf life: 36 months when stored in tightly closed containers, protected from light, at controlled room temperature. |
Manufacture of streptomycin sulphate as a sterile lyophilized powder begins with an assay-adjusted fill weight calculation, because the sulphate salt cannot be treated as a 1:1 replacement for streptomycin base. The batch certificate of analysis supplies the base-equivalent assay that determines dry fill weight; at a typical batch assay of 720 µg/mg, delivery of 1.0 g streptomycin base per vial requires 1.389 g sulphate salt. The lyophilized cake contains no bulking excipients, so the dry solids are essentially 100% API solids, with only trace sodium hydroxide or hydrochloric acid used to adjust pre-filtration solution pH to compendial limits. The formulated solution is prepared at 200–400 mg/mL base equivalent, passed through a 0.22 µm sterilizing-grade membrane, and aseptically filled into Type I borosilicate glass vials under Grade A conditions within a Grade B cleanroom. Lyophilization uses a freezing plateau below −40 °C, primary drying chamber pressure of 0.1–0.2 mbar, and condenser temperature below −60 °C; endpoint is confirmed by comparative pressure measurement and residual moisture by Karl Fischer titration under USP <921>, with a release limit not more than 1.0% for aminoglycoside lyophiles. Batch failures on production-scale freeze dryers commonly arise from cake collapse when shelf heat input exceeds the glass transition of the frozen matrix, from stopper moisture uptake that raises residual water after closing, and from vial-to-vial fill weight drift on rotary piston fillers when solution temperature changes during extended filling campaigns. Sterility assurance is governed by 21 CFR 211.113 environmental controls, 21 CFR 211.165 release testing, USP <71> Sterility Tests, USP <85> Bacterial Endotoxins Test, USP <788> Particulate Matter in Injections, and ICH Q7 Section 12.5 process validation. The terminal product is a single-dose vial labeled as 1.0 g streptomycin base, intended for reconstitution and deep intramuscular injection in tuberculosis and brucellosis regimens, or further dilution for intravenous infusion.
| Process parameter | Control range / standard designation |
|---|---|
| Sulphate salt-to-base fill correction | Assay-derived; 1.389 g sulphate per 1.0 g base at 720 µg/mg batch assay |
| Pre-filtration solution concentration | 200–400 mg/mL base equivalent |
| Sterilizing filtration | 0.22 µm membrane; ASTM F838-20 bacterial retention integrity test |
| Freezing plateau | Below −40 °C; collapse temperature determined by freeze-drying microscopy |
| Primary drying chamber pressure | 0.1–0.2 mbar |
| Condenser temperature | Below −60 °C |
| Residual moisture release | NMT 1.0% by USP <921> Karl Fischer titration |
| Sterility / endotoxin / particulate | USP <71>, USP <85>, USP <788> |
In centralized intravenous admixture services, the lyophilized vial is reconstituted under ISO Class 5 conditions to an intermediate concentration that must be recorded as a label-relevant dilution step, because the sulphate salt mass and the base-equivalent label claim differ. The 1.0 g base vial is reconstituted with 2.5 mL Sterile Water for Injection to produce an approximate 400 mg/mL base-equivalent solution for deep intramuscular injection; the same vial may be reconstituted with 4.6 mL to produce an approximate 200 mg/mL solution for intravenous admixture. The addition ratio for a typical 1.0 g intravenous infusion is 200 mL of 0.9% sodium chloride or 5% dextrose, yielding 5 mg/mL; infusion time is typically controlled between 30 min and 60 min to reduce the risk of rapid peak serum concentrations and neuromuscular blockade. Compounding personnel operate under USP <797> Pharmaceutical Compounding—Sterile Preparations, with beyond-use dating assigned by risk level, storage temperature, and sterility assurance level rather than by the vial manufacturer’s expiry date; the compounding record includes filter lot, diluent lot, pump calibration, and visual particulate inspection. The finished presentation is a single-use intravenous infusion bag, usually 100–250 mL, administered via an infusion pump with in-line filtration where the clinical protocol requires particulate control. This downstream use is a high-frequency hospital process; the main production-scale failure points are foaming during reconstitution, incomplete dissolution of the lyophilized cake when the diluent is injected too quickly, and dose calculation errors arising from confusion between sulphate salt mass and streptomycin base mass.
Oral streptomycin sulphate tablet development is driven by the need to retain the drug in the gastrointestinal lumen for local antimicrobial action, not by systemic absorption; intact intestinal mucosa limits oral bioavailability to a clinically negligible level. The addition ratio is calculated from the batch assay: for a 250 mg base tablet using a sulphate salt assay of 720 µg/mg, the required salt mass is 347.2 mg; with a core weight of 500 mg, the API fraction is 69.4% w/w, and the remaining 30.6% w/w comprises a compatible filler such as microcrystalline cellulose, a disintegrant such as croscarmellose sodium, and a lubricant such as sodium stearyl fumarate. The tablet process uses wet granulation in a high-shear granulator, followed by fluid-bed drying at a product temperature not exceeding 40 °C and a final loss on drying below 2.0%; compression on a rotary press with precompression maintains tablet break force between 60 N and 90 N, and friability is controlled below 1.0% under USP <1216>. Release testing for a commercial batch includes 21 CFR 211.165, USP <905> Uniformity of Dosage Units with an acceptance value not exceeding 15.0, USP <701> disintegration in 900 mL water at 37 °C, and a dissolution method under USP <711> if a finished-product monograph exists; if no monograph method is available, the dissolution procedure must be validated per ICH Q2(R1). Elemental impurities are controlled by ICH Q3D; stability testing follows ICH Q1A(R2) under Zone III or Zone IV conditions depending on target market. The terminal products are uncoated oral tablets labeled as 250 mg or 500 mg streptomycin base, intended for local gut decontamination where systemic exposure is undesirable. Commercial production of this dosage form is a limited configuration; published data for specific marketed formulations is limited.
Capsule filling of streptomycin sulphate for oral local therapy imposes a stricter relative humidity envelope than tablet compression because the dried sulphate salt can transfer moisture to gelatin shells and cause shell deformation, brittleness, or cross-linking during storage. A 500 mg base capsule formulated with a sulphate batch assay of 720 µg/mg requires 694.4 mg sulphate salt; an additional 53.6 mg of pregelatinized starch and 2.0 mg of sodium stearyl fumarate produces a total powder fill of 750 mg, giving an API fraction of 92.6% w/w. The powder blend is filled into hard gelatin capsules on a dosator-type encapsulation machine; the powder hopper is conditioned at 30–40% RH, and the empty capsule shells are maintained at 13–16% moisture to prevent powder adhesion to dosator pins and shell telescoping. In-process controls include fill weight verification every 15–30 min, capsule disintegration under USP <701>, and content uniformity under USP <905>; moisture content of the final filled capsule is limited to 2.0% by USP <921>. Packaging in HDPE bottles with a desiccant canister is required for Zone III and Zone IV climates, and stability studies follow ICH Q1A(R2) with open-dish moisture stress testing where the API shows hygroscopicity. Finished capsule products are 250 mg and 500 mg base oral capsules for gastrointestinal luminal antimicrobial action; because oral bioavailability is minimal under intact mucosa, systemic exposure remains below the threshold associated with injectable use. Published commercial examples for streptomycin sulphate capsules are limited, and the above fill formula is an assay-corrected development formula rather than a marketed product specification.
Granule presentations for oral reconstitution shift the manufacturing bottleneck from powder flow and tablet compression to moisture control during fluid-bed drying and aluminum sachet sealing integrity. The addition ratio for a 500 mg base sachet at a sulphate batch assay of 720 µg/mg is 694.4 mg sulphate salt in a 2.0 g total granule fill, yielding an API fraction of 34.7% w/w; the remainder consists of mannitol as a water-soluble diluent, sodium citrate as a buffering agent to reduce the bitter aminoglycoside saltiness, xanthan gum as a suspending agent, and a flavor system. Granulation is performed in a high-shear mixer, wet-milled through a 1.5 mm screen, and dried in a fluid-bed dryer at product temperature 35–40 °C until loss on drying is below 2.0%; particle size distribution is controlled through 1.0 mm and 2.0 mm screens to ensure sachet-to-sachet uniformity below 5.0% RSD. The dried granules are filled into aluminum-foil unit-dose sachets under 30–40% RH; seal integrity is evaluated by dye penetration under USP <1207> or an equivalent package integrity test. Release testing follows 21 CFR 211.165, USP <905> for single-dose weight variation, and a dissolution procedure under USP <711> using 900 mL purified water at 37 °C; if a specific monograph for oral streptomycin sulphate granules does not exist, the dissolution specification is developed and validated per ICH Q2(R1). The finished product is a unit-dose sachet containing granules for oral suspension, reconstituted in 20 mL water immediately before administration, intended for local gastrointestinal decontamination. Published data for commercial streptomycin sulphate granules is limited; this format is not a principal trading configuration in current human medicine.
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Streptomycin sulphate, CAS 3810-74-0, is a fermentation-derived aminoglycoside antibiotic supplied as a white to off-white hygroscopic powder. The product is available in three pharmaceutical-grade article models: STM-SUL-720-TC for direct-compression tablet and capsule formulations, STM-SUL-720-GRD for granule processes, and STM-SUL-720-INJ for sterile dry powder injection. The suffix 720 reflects the minimum compendial potency of 720 IU/mg on the dried basis, where each international unit corresponds to one microgram of streptomycin base. The molecule binds the 16S rRNA A-site of the 30S ribosomal subunit, causing codon misreading and aborted translation. Oral tablet, capsule, and granule presentations rely on limited systemic absorption of the drug after oral administration, whereas injectable presentations deliver measurable serum concentrations for systemic infections including tuberculosis, plague, and tularemia. Unlike simple chemical APIs, streptomycin sulphate is a complex of streptomycin base and sulfuric acid; its sulfate form is freely soluble in water and practically insoluble in ethanol. That solubility profile supports aqueous reconstitution for injection but also imposes humidity controls during dispensing, blending, and tablet compression. The API must therefore be specified by potency, identity, loss on drying, related substances, particle-size distribution, and—for injectable use—bacterial endotoxin and particulate control.
Release specifications are anchored to the Ph. Eur. general monograph for streptomycin sulphate 0353, the current USP Streptomycin Sulfate monograph, Ph. Eur. 2.7.2 for microbiological assay, and USP 81 for antibiotic microbial assays. Potency acceptance is not less than 720 IU/mg on the dried basis. Identity is confirmed by infrared absorption against a reference standard and by HPLC retention time. Related substances are controlled by chromatographic methods because fermentation-derived minor aminoglycoside components are not separated reliably by pharmacopoeial titration. Loss on drying is controlled per Ph. Eur. 2.2.32 or USP 731; the powder is hygroscopic, so uncontrolled moisture uptake during sampling can alter assay values, flow function, and tablet hardness. Solution pH is controlled on a 1.0% aqueous solution per Ph. Eur. 2.2.3 or USP 791; a typical acceptance window for aminoglycoside sulfate salts is 4.5–7.0, which minimizes base-catalyzed degradation of the streptidine and N-methyl-L-glucosamine moieties. Residual solvents are limited by ICH Q3C, and elemental impurities are controlled by ICH Q3D using a documented risk assessment for Class 1, 2A, 2B, and 3 elements. Injectable-grade material adds bacterial endotoxin testing per Ph. Eur. 2.6.14 or USP 85; a representative release criterion is ≤0.25 EU/mg for a maximum single dose of 1 g. Oral grade is controlled by non-sterile microbial limits per Ph. Eur. 5.1.4, USP 61, and USP 62. Oral and injectable grades are not interchangeable solely on assay because injectable material requires lower bioburden, controlled endotoxin, and a particle-size distribution that supports rapid dissolution in Water for Injection without visible particulate matter.
| Quality attribute | Test method or standard | Oral tablet/capsule/granule grade | Injectable grade |
|---|---|---|---|
| Potency | Ph. Eur. 2.7.2 / USP 81 | ≥720 IU/mg dried basis | ≥720 IU/mg dried basis |
| Bacterial endotoxin | Ph. Eur. 2.6.14 / USP 85 | Not specified for non-sterile oral use | ≤0.25 EU/mg |
| Sterility | Ph. Eur. 2.6.1 / USP 71 | Not specified | Sterile |
| Identity | IR / HPLC | Conforms to reference spectrum and retention time | Conforms to reference spectrum and retention time |
| Loss on drying | Ph. Eur. 2.2.32 / USP 731 | Monograph limit | Monograph limit |
| pH of solution | Ph. Eur. 2.2.3 / USP 791 | 4.5–7.0 | 4.5–7.0 |
| Residual solvents | ICH Q3C | Class 3 limits | Class 3 limits |
| Elemental impurities | ICH Q3D | Risk-based acceptance | Risk-based acceptance |
On high-speed rotary tablet presses operating at turret speeds between 30 rpm and 80 rpm, flow function coefficient and particle-size uniformity matter more than chemical purity alone. Streptomycin sulphate powder is hygroscopic; exposure at relative humidity above 60% causes surface moisture adsorption, capping, and punch filming on compression tooling. Dry granulation by roller compaction is therefore preferred for oral tablet and capsule formulations. The granulator grade STM-SUL-720-GRD is milled through a screen with nominal aperture between 800 µm and 1000 µm after compaction to destroy oversized dense ribbons while retaining granule porosity. Blend uniformity is monitored per USP 905 and Ph. Eur. 2.9.40, with final blend RSD typically controlled at ≤5.0% for batch release. Low-dose capsule formulations with fill weight below 250 mg generally require API D90 ≤75 µm to prevent assay segregation in high-speed encapsulation. Tablet hardness, disintegration, and dissolution follow USP 701, Ph. Eur. 2.9.1, and USP 711 / Ph. Eur. 2.9.3. Because streptomycin sulphate is freely soluble in water, dissolution is rarely rate limiting for conventional-release oral dosage forms; disintegration is frequently sufficient as a critical quality attribute. Excipient selection should avoid strongly alkaline fillers such as sodium bicarbonate because microenvironmental pH above 8.0 accelerates base-catalyzed hydrolysis of the streptidine ring and reduces potency. For wet granulation, the binder solution should be added as a low-water granulation fluid and the wet mass dried immediately in a fluid-bed dryer with inlet air dew point no higher than -10°C and product temperature below 45°C to limit hydrate conversion and caking.
Injectable-grade streptomycin sulphate is manufactured under a different control strategy from oral grade. The crystallizer feed is prepared with Water for Injection, and contact surfaces of the centrifuge, dryer, mill, and filling equipment are depyrogenated. Aseptic filtration is applied to the process stream before final crystallization or after dissolution in the filling line, depending on the validated process design. The dry powder is filled into Type I borosilicate glass vials with halobutyl rubber closures. Terminal moist-heat sterilization of the dry powder is generally unsuitable because the product is hygroscopic and steam penetration causes caking, discoloration, and potency loss; therefore, aseptic processing or validated dry-heat conditions must be justified by stability data. Published data for this specific configuration is limited because each manufacturing site must qualify its own sterilizing-grade filter, isolator airflow, and media-fill performance under ICH Q7. Micronization of injectable-grade material under aseptic conditions introduces electrostatic charge that can cause powder adhesion to equipment surfaces and variable filling; processing rooms should be humidity controlled and all fluid-energy mill contact points grounded.
During reconstitution, the dry powder must dissolve entirely within the label-specified time using sterile Water for Injection. Visible particulate matter is controlled by USP 790 and Ph. Eur. 2.9.20. If the same intravenous line is used for a beta-lactam antibiotic, physical or chemical incompatibility in the infusion lumen can reduce aminoglycoside potency by acylation of primary amino groups; separate infusion lines or sequential flushing with sodium chloride 0.9% is required. pH excursions above 8.0 during compounding accelerate degradation of the streptidine ring and should be avoided. Injectable grade is not interchangeable with oral grade because oral grade bioburden and endotoxin levels may exceed parenteral limits even when the potency assay passes. Injectable batches should also be controlled for osmolality of the reconstituted solution, though the osmolar contribution depends on final reconstitution volume and must be calculated for each preparation strength.
Streptomycin sulphate is not a broad equal of other aminoglycosides. Its primary contemporary niche is treatment of tuberculosis caused by Mycobacterium tuberculosis in combination regimens, Yersinia pestis, Francisella tularensis, and selected enterococcal endocarditis regimens with a beta-lactam when susceptibility is confirmed. Gentamicin, tobramycin, and amikacin have broader activity against Pseudomonas aeruginosa and nosocomial Enterobacterales; streptomycin is not selected for empirical Gram-negative nosocomial monotherapy. Compared with neomycin sulfate, which is largely restricted to oral and topical use because of severe nephrotoxicity and neuromuscular blockade potential after systemic absorption, streptomycin sulfate can be given by intramuscular or intravenous injection with appropriate audiometric and renal monitoring. Dihydrostreptomycin, another streptomycin-derived aminoglycoside, has a different toxicity profile with cochlear predominance and is not considered interchangeable. The sulfate salt is used instead of chloride or other salts because sulfate provides crystallinity, acceptable aqueous solubility, and well-characterized compendial identity. Oral tablet/capsule/granule presentations take advantage of poor gastrointestinal absorption for local suppression of gut flora, whereas injectable presentations are needed for systemic infections. This is a formulation-specific difference from gentamicin sulfate, which is primarily marketed as a parenteral solution and is poorly absorbed after oral administration.
Resistance to streptomycin occurs via chromosomal mutations in rpsL and rrs genes in Mycobacterium tuberculosis, and via plasmid-borne aminoglycoside-modifying enzymes in Enterobacterales. This is an efficacy boundary, not a formulation defect. In clinical use, streptomycin-induced nephrotoxicity and vestibular ototoxicity are cumulative and dose-related. Renal function and serum drug levels should be monitored because aminoglycoside clearance is proportional to creatinine clearance. Coadministration with loop diuretics or other ototoxic agents may worsen cochlear and vestibular injury. Avoid use in patients with renal impairment unless dose adjustment is guided by therapeutic drug monitoring and no safer alternative is available. These constraints are intrinsic to the aminoglycoside class and apply regardless of whether the API is processed into a tablet, capsule, granule, or injectable dosage form.
