| HS Code | 582161 |
| Productname | Sodium Lactate Solution USP/BP/EP/JP/CHP Pharma Grade API |
| Chemicalname | Sodium 2-hydroxypropanoate |
| Synonyms | Sodium lactate; Lactic acid sodium salt; Sodium DL-lactate |
| Casnumber | 72-17-3 (sodium lactate); 867-56-1 (L-sodium lactate) |
| Enumber | E325 |
| Molecularformula | C3H5NaO3 |
| Molecularweight | 112.06 g/mol |
| Appearance | Clear, colorless to slightly yellowish, slightly viscous liquid |
| Odor | Odorless or faint characteristic odor |
| Taste | Mild saline taste |
| Assay | 50.0%–60.0% w/w sodium lactate |
| Ph | 6.0–8.0 |
| Concentration | Typically 50%–60% w/w; custom concentrations available |
| Density | Approximately 1.20–1.32 g/mL at 25°C depending on concentration |
| Solubility | Miscible with water; soluble in ethanol; practically insoluble in nonpolar solvents |
| Grade | Pharma Grade / API Grade |
| Pharmacopoeialcompliance | USP, BP, EP, JP, CHP |
| Dosageforms | Tablet, Capsule, Granule, Injection, Oral Solution |
| Routeofadministration | Oral and Injectable |
| Sterility | Non-sterile or sterile grade available for injectable use |
| Endotoxin | Low endotoxin / BET-controlled grades available for injectable use |
| Heavymetals | ≤10 ppm |
| Storage | Store in tightly closed containers, protected from light, at controlled room temperature (15–30°C); avoid freezing |
| Packaging | HDPE drums, jerry cans, and bulk containers |
| Shelflife | 24–36 months when stored properly |
| Manufacturingstandard | GMP, ICH Q7, pharmacopoeial monographs |
| Regulatorysupport | DMF, CEP, COA, MSDS, GMP certificate available |
As an accredited Sodium Lactate Solution USP/BP/EP/JP/CHP 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 | |
| Shipping | |
| Storage |
Sodium lactate solution supplied as a 50–60% w/w aqueous solution conforming to USP, BP/EP, JP, and CHP monographs is incorporated into Lactated Ringer’s Injection USP and Hartmann’s Solution for Injection Ph. Eur. as the alkalizing component at a final concentration of 28 mmol/L lactate. In a 1000 L batch, 3.10 kg anhydrous sodium lactate is supplied as 5.17 kg of 60% w/w sodium lactate solution or 6.20 kg of 50% w/w solution, alongside 6.00 kg sodium chloride, 0.30 kg potassium chloride, and 0.20 kg calcium chloride dihydrate in Water for Injection. The finished electrolyte profile must be 130 mmol/L sodium, 4 mmol/L potassium, 2.7 mmol/L calcium, 109 mmol/L chloride, and 28 mmol/L lactate. The manufacturing sequence adds sodium lactate solution to approximately 70% of final volume Water for Injection at 20–30°C under agitation at 150–250 rpm in a stainless steel mixing vessel before calcium chloride is introduced, because localized high pH around concentrated sodium lactate can precipitate calcium lactate if calcium chloride is added first. The pH is adjusted to 6.0–7.5 with 0.1 M hydrochloric acid or 0.1 M sodium hydroxide and verified according to USP <791>. The solution is filtered through a 0.2 µm polyethersulfone membrane and terminally sterilized by moist heat at 121°C for 15 minutes. Sodium lactate remains stable under these sterilization conditions, and unlike sodium bicarbonate it does not release carbon dioxide in sealed flexible polyolefin containers. Compliance includes the USP monograph for Lactated Ringer’s Injection, USP <85> bacterial endotoxins, USP <788> particulate matter, USP <232> / USP <233> elemental impurities, and USP <467> residual solvents. The final product is a clear, colorless, sterile isotonic solution supplied in 250 mL, 500 mL, and 1000 mL infusion bags.
For formulation calculations, the quantity of 60% w/w sodium lactate solution per litre for common final lactate concentrations is listed below.
| Final lactate concentration (mmol/L) | Volume of 60% w/w solution per litre (mL/L) |
|---|---|
| 1 | 0.141 |
| 5 | 0.704 |
| 10 | 1.41 |
| 20 | 2.82 |
| 28 | 3.94 |
| 40 | 5.63 |
Calculated at 20°C using solution density 1.32 g/mL and sodium lactate molar mass 112.06 g/mol.
In ready-to-use oral electrolyte solutions, sodium lactate solution is preferred over dry sodium bicarbonate because it does not cause carbon dioxide effervescence during cold-fill packaging and remains uniform in low-pH sugar-containing carbohydrate systems. A typical final lactate concentration of 10–20 mmol/L in a 1000 L batch is achieved by adding 1.41 L to 2.82 L of 60% w/w sodium lactate solution after the carbohydrate component has been dissolved and cooled to 25–35°C. The solution is diluted with purified water to final volume in a stainless steel or high-density polyethylene mixing tank under agitation at 200–300 rpm. The pH is then adjusted to the product-specific range, typically 4.0–5.0, using 10% w/v citric acid or 0.5 M sodium hydroxide, and verified according to USP <791>. The product is passed through a 1 µm polypropylene depth filter and filled into 500 mL or 1000 mL multi-dose polyethylene terephthalate bottles. If a preservative is present, the formulation must satisfy USP <51> antimicrobial effectiveness testing; the addition of sodium lactate solution at the stated concentrations does not substitute for preservative efficacy. The finished oral liquid is a clear, slightly saline solution used as an electrolyte replenisher in fluid and electrolyte loss conditions. Because the 60% w/w solution has a density of approximately 1.32 g/mL at 20°C, in-line mass-flow metering is preferred over volumetric metering to avoid lot-to-lot variability caused by temperature-dependent density shifts.
Sodium lactate is used in peritoneal dialysis solutions as a metabolizable base source, with final lactate concentrations of 35–40 mmol/L and sodium concentrations of 132–134 mmol/L. The use of lactate instead of bicarbonate in single-chamber peritoneal dialysis products avoids calcium carbonate precipitation during steam sterilization and eliminates carbon dioxide accumulation in sealed PVC-free containers. For a 1000 L batch of 1.5% w/v dextrose peritoneal dialysis solution, the glucose monohydrate is first dissolved in Water for Injection at 60–70°C, the solution is cooled to 25–35°C, and 4.93–5.63 L of 60% w/w sodium lactate solution is introduced to deliver 35–40 mmol/L lactate. Calcium chloride and magnesium chloride are added separately as dilute solutions and only after sodium lactate is fully dispersed to prevent lactate salt precipitation. The pH is adjusted to 5.0–5.5 with hydrochloric acid before terminal sterilization because glucose degradation to 5-hydroxymethylfurfural and related degradation products accelerates at higher pH and autoclave temperatures. The filled containers are autoclaved at 121°C for 15 minutes; the low pH before sterilization is therefore a critical process control point. After sterilization, the pH of the finished product rises into the physiological range as lactate establishes equilibrium. Compliance includes the monograph for peritoneal dialysis solutions, USP <85> bacterial endotoxins, USP <788> particulate matter, and the manufacturer’s validated limit for glucose degradation products. The finished product is a sterile, clear, colorless solution supplied in 2 L, 2.5 L, or 3 L single-use bags.
| Application route | Critical control parameter | Test method/standard | Operational boundary |
|---|---|---|---|
| Lactated Ringer’s Injection | pH | USP <791> | 6.0–7.5 |
| Oral electrolyte solution | Antimicrobial preservation | USP <51> | Pass criteria for bacteria and fungi |
| Peritoneal dialysis fluid | pH before sterilization | USP <791> | 5.0–5.5 |
| Wet granulation | Loss on drying | USP <731> | ≤2.0% w/w after drying |
| Injectable admixture | Bacterial endotoxins | USP <85> | Compendial injectable limit |
| Oral syrup | pH | USP <791> | 4.5–5.5 |
When wet granulation requires a low-carbonate liquid binder for acid-sensitive active pharmaceutical ingredients, 60% w/w sodium lactate solution may be used at addition levels of 0.5–2.0% w/w based on dry granulate mass. The granulation liquid is prepared by diluting 1 part of 60% w/w sodium lactate solution with 2–4 parts purified water, producing a stock containing approximately 1.4–2.4 mmol/g sodium lactate, which is then sprayed into a high-shear granulator. In batches with 50 kg dry powder load, 0.25–1.0 kg of 60% w/w sodium lactate solution is combined with 0.5–4.0 kg purified water and mixed with the dry blend for 4–8 minutes at an impeller speed of 150–250 rpm and chopper speed of 1000–1500 rpm. The wet mass is passed through a 1.6–2.0 mm screen and dried in a fluid-bed dryer at inlet air temperature 50–60°C until loss on drying measured by USP <731> is ≤2.0% w/w. Sodium lactate is hygroscopic; if dried granules are stored above 60% relative humidity, they will soften and stick during compression. The dried granulate is blended with magnesium stearate at 0.5–1.0% w/w for 3–5 minutes, compressed into tablets using a rotary press with 10–25 kN compression force, or filled into hard capsules. The granulation process is suitable only for actives that tolerate residual sodium lactate and mildly alkaline microdomains; it is not suitable for moisture-sensitive actives where residual water content must remain below 0.5% w/w. The finished dosage forms must comply with USP <711> dissolution and USP <701> disintegration. Published data for sodium lactate as a primary binder in large-scale tableting is limited; the addition range above is derived from commercial granulation practice rather than a pharmacopeial monograph.
When injectable admixtures require a base source that does not evolve carbon dioxide during aseptic filling, 60% w/w sodium lactate solution is diluted 1:10 with Water for Injection to produce a stock containing approximately 0.71 mol/L lactate. A final lactate concentration of 10 mmol/L in a 1 L intravenous admixture requires 14.1 mL of this 1:10 stock. The addition is performed after the primary active pharmaceutical ingredient has been dissolved and the solution is cooled to 20–25°C, with continuous low-shear mixing at 50–100 rpm to reduce air entrainment. The pH is measured with a calibrated electrode according to USP <791>, and if further adjustment is required, 0.1 M hydrochloric acid or 0.1 M sodium hydroxide is used. The completed solution is passed through a 0.22 µm PVDF sterilizing-grade filter and aseptically filled into Type I borosilicate glass vials under Grade A laminar airflow. Sodium lactate is not used in admixtures containing calcium salts above 5 mmol/L unless a compatibility study confirms the absence of calcium lactate precipitation. It is also not added to lipid-containing total parenteral nutrition admixtures before confirming emulsion stability by droplet size analysis, because electrolytes can reduce zeta potential and trigger coalescence. Compliance is based on USP <797> for compounded sterile preparations, USP <85> bacterial endotoxins, and USP <788> particulate matter. The finished injectable is a sterile, preservative-free solution intended for immediate use or short-term refrigerated storage at 2–8°C.
Oral syrups and elixirs containing weak organic acids are buffered with sodium lactate solution at 0.1–0.5% w/w of 60% w/w solution to maintain pH between 4.5 and 5.5 without breaking the sucrose-glycerin matrix. The sodium lactate solution is added after the syrup base has been cooled to 25–30°C and before the addition of the preservative. In a 500 kg batch, 0.5–2.5 kg of 60% w/w solution is introduced under propeller agitation at 200–400 rpm for 30 minutes. The pH is checked per USP <791> and adjusted with 0.1 M citric acid or 0.1 M sodium hydroxide if outside the target range. The syrup is passed through a 0.45 µm membrane filter and filled into 100 mL or 200 mL amber glass bottles. If a preservative system is present, the finished product must pass USP <51> antimicrobial effectiveness testing; sodium lactate contributes to water activity reduction but cannot replace a preservative. The finished product is a clear, viscous oral solution used as an alkalizing agent and vehicle for active pharmaceutical ingredients that are unstable at neutral pH. The process is limited to formulations with total solids above 40% w/w; below this level, the humectant effect of sodium lactate may be insufficient to prevent microbial growth, and preservative concentration must be increased.
Competitive Sodium Lactate Solution USP/BP/EP/JP/CHP Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable 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!
The product is an aqueous pharmaceutical-grade sodium lactate solution designated USP/BP/EP/JP/CHP Pharma Grade API for tablet, capsule, granule, oral solution, and injectable manufacture. The active entity is sodium (RS)-2-hydroxypropanoate, C3H5NaO3, with CAS RN 72-17-3 for the anhydrous salt and CAS RN 867-56-1 for the aqueous solution. The anhydrous molar mass is 112.06 g/mol, of which sodium accounts for approximately 20.5% by mass; the supplied liquid is a clear, colourless to pale yellow, slightly viscous aqueous system at a nominal 60% w/w active content. Consequently, 1.000 kg of bulk solution contains approximately 600 g sodium lactate and 123 g sodium. The material is intended as an active pharmaceutical ingredient, not as a commodity pH adjuster. The present grade is controlled against relevant monograph tests for identity, assay, pH, chloride, sulfate, oxalate, citrate, heavy metals, arsenic, water content, and, for parenteral use, bacterial endotoxins and particulate matter as specified in the applicable injection monograph. Because the solution is water-miscible and weakly alkaline in dilution, transfer lines and storage vessels are specified in closed stainless steel, high-density polyethylene, or polypropylene; prolonged contact with unprotected carbon steel or aluminum is avoided because the aqueous electrolyte phase supports corrosion. The product should not be confused with lactic acid or lactate ester solvents; it is the neutral sodium salt of lactic acid and therefore exhibits different pH, osmolality, and container compatibility.
Distinction between pharmacopeial-grade solution and technical lactate products is not established by gross assay alone. Technical material may show an apparently acceptable sodium lactate titre yet fail pharmacopoeial limits for oxalate, citrate, chloride, sulfate, reducing impurities, or colour after heating. Oxalate is critical in parenteral applications because residual oxalate can form low-solubility calcium oxalate when the solution is mixed with calcium-containing infusion fluids; monograph limits are therefore set below the threshold that prevents precipitation at clinically relevant concentrations. Identity testing includes the sodium flame test and lactate-specific chemical reactions; assay is performed by an appropriate titrimetric, HPLC, or ion-exclusion procedure as defined in the current monograph. The pH of a 10% aqueous dilution is controlled in the range 6.5–7.5, and the solution is examined for colour and clarity against reference standards. Water content is determined by Karl Fischer titration under USP <921>, and the assay is expressed on the anhydrous basis. Bacterial endotoxins for injectable grades are controlled by USP <85> and Ph. Eur. 2.6.14; sterility, when the API is supplied sterile, follows USP <71> and Ph. Eur. 2.6.1. Non-sterile oral grades are tested under USP <61> and <62> for total aerobic microbial count, total yeast and mould count, and specified organisms. Elemental impurities are evaluated according to ICH Q3D using USP <232>/<233> or equivalent EP procedures; the audit must confirm that no nickel catalyst or chromium-bearing alloy components are present in the fermentation and purification train. Residual solvent testing is performed under USP <467> when volatile organic solvents are used; water-based lactic acid neutralization processes typically show no reportable methanol, ethanol, or dichloromethane, but the limit applies to the API. The certificate of analysis should include actual batch values, not only pass/fail statements, to support downstream process capability analysis.
During wet granulation for tablet and capsule formulations, sodium lactate solution is most frequently introduced as a dissolved binder or alkalising agent at concentrations below 2.0% w/w of dry granulate; higher loadings are technically feasible only when the formulation is designed for sustained alkalisation, such as oral rehydration salts. The aqueous mass contribution of the 60% solution means that 1.0 kg of active solution adds approximately 400 g of water that must be removed. Production-scale high-shear granulators, typically with impeller tip speed 4–8 m/s, produce acceptable consistency when the solution is metered at low rates; excess addition leads to over-wetting, dough formation, and eventual impeller torque fault. Drying in a top-spray fluid bed at inlet air temperature 60°C–70°C and final granule moisture below 2.0% w/w is necessary before compression because residual water plasticises the amorphous regions of common fillers such as microcrystalline cellulose and reduces tablet fracture strength. If the final granulate contains more than 5% w/w moisture, capping and sticking on punch faces may be observed on rotary tablet presses. The hygroscopic nature of dried lactate-containing granules requires that compression areas be controlled at 40%–50% relative humidity; outside this range, water uptake can increase weight variation and prolong disintegration time. Disintegration and dissolution are evaluated by USP <701> and USP <711> for the finished tablet or capsule.
For capsule filling and granule sachets, the dried particles exhibit a mild tack when heated by mechanical friction, especially on dosator-type capsule machines. Roll-compacted granules are preferred over direct compression for sodium lactate-containing formulations above 10% w/w because the coarse fibres and needle-shaped crystals obtained from spray-crystallised sodium lactate have poor flow. Flowability is quantified by Carr index or Hausner ratio; batch release may set a maximum Carr index of 25 for automated filling. Addition of glidant such as colloidal silicon dioxide at 0.25%–0.50% w/w improves flow, but the alkaline surface of dried granules can adsorb acidic actives and alter dissolution if the formulation contains pH-dependent enteric coatings. For enteric-coated capsules, local pH at the granule surface must be evaluated because sodium lactate can create a transient microclimate that accelerates premature dissolution of enteric polymers such as methacrylic acid–ethyl acrylate copolymer. Published data for sodium lactate-specific enteric stability is limited; therefore a stripping test using 0.1 M hydrochloric acid followed by pH 6.8 phosphate buffer is used to verify the coating integrity.
Injectable compounding with sodium lactate solution is constrained by terminal sterilization behaviour and container compatibility. The diluted solution is typically filtered through a 0.22 µm sterilising-grade polyethersulfone or PVDF membrane before aseptic filling; if terminal sterilization is used, a standard cycle at 121°C for 15 min gives an F0 value of approximately 15 min. However, sodium lactate is not fully inert under thermal stress. Trace oxygen and heavy metal ions can promote oxidative cleavage to acetate, pyruvate, or coloured condensation products; therefore headspace oxygen in glass vials or flexible containers should be displaced with nitrogen and the fill volume limited to the specified headspace. The pH of the solution after steam sterilisation may shift by more than 0.2 units if buffers are absent; this shift should be evaluated by stability-indicating HPLC or pharmacopoeial organic acid assay. Pre-sterilisation pH adjustment with dilute sodium hydroxide or hydrochloric acid is generally required, but the target pH must account for the shift; the final solution pH is commonly set between 6.0 and 7.5. Sodium lactate injection is incompatible with certain glass types if the solution is alkaline; type I borosilicate glass is preferred, and the container inner surface may require sulfate or ammonium sulfate treatment to reduce delamination for high-pH or high-temperature conditions. Particulate matter after sterilization is controlled by USP <788> and Ph. Eur. 2.9.19. Terminal sterilisation of sodium lactate-containing solutions in semipermeable plastic containers is not universally applicable because water vapour loss alters osmolality and concentration; each container configuration requires a documented worst-case load validation.
Because sodium lactate solution is supplied as a neutral salt, its behaviour differs materially from lactic acid, potassium lactate, sodium chloride, and lactate esters. Lactic acid at 0.1 M has a pH of approximately 2.4 because its pKa is 3.86 at 25°C; sodium lactate solution diluted to the same molarity is essentially neutral and therefore will not protonate weakly basic active substances. Potassium lactate solution contains potassium instead of sodium and introduces a different electrolyte load; the anhydrous potassium salt has a molar mass of 128.17 g/mol, so a 60% potassium lactate solution delivers approximately 18.3% potassium, whereas a 60% sodium lactate solution delivers approximately 12.3% sodium. Sodium chloride contains 39.3% sodium but no metabolizable anion and no buffering effect, while the lactate anion is metabolized to bicarbonate in hepatic and renal bicarbonate cycles; this difference is pharmacokinetically relevant because sodium lactate addition is used to supply base without direct sodium bicarbonate. Lactate esters such as ethyl lactate or butyl lactate are solvents or flavour agents, not interchangeable with the sodium lactate API, because they do not contribute sodium and are not used for parenteral alkalisation. The present API should also not be confused with sodium lactate powder, which is highly hygroscopic and may contain lower residual water but is supplied as a solid with different handling risk.
| Substance | Molecular formula | Molar mass (g/mol) | Cation or active species content (% w/w) | Dilute aqueous pH |
|---|---|---|---|---|
| Sodium lactate anhydrous | C3H5NaO3 | 112.06 | 20.5% Na | 6.5–7.5 |
| Sodium lactate 60% solution | C3H5NaO3·aq | not applicable | 12.3% Na | 6.5–7.5 |
| Potassium lactate 60% solution | C3H5KO3·aq | 128.17 anhydrous | 18.3% K | 6.5–8.0 |
| Sodium chloride | NaCl | 58.44 | 39.3% Na | 4.5–7.0 in aqueous solution |
| Lactic acid | C3H6O3 | 90.08 | no cation | 2.4 for 0.1 M |
Oral and injectable formula design boundaries follow from the physicochemical profile. Because sodium lactate provides sodium without chloride, it is used in parenteral maintenance fluids where hyperchloremic acidosis is a concern. A 1/6 molar sodium lactate solution contains 167 mmol/L sodium and 167 mmol/L lactate; calculated osmolarity is approximately 334 mOsmol/L, which is near isotonicity. Chloride is absent, which distinguishes it from sodium chloride-based diluents. However, sodium lactate solution is not a ready-to-use infusion; it must be diluted or incorporated into a defined parenteral formula. In oral tablets, the sodium content per dosage unit must be declared because 100 mg of anhydrous sodium lactate supplies 20.5 mg of sodium. For sachet formulations, the pH after reconstitution should be verified in the intended vehicle because sodium lactate can reduce the solubility of weakly basic actives by increasing ionic strength. Osmolality measurements may be performed by freezing-point depression, and osmolality targets are generally expressed in mOsmol/kg.
Bulk handling and storage boundaries are determined by water activity, viscosity, and microbial growth potential. The bulk API is supplied in high-density polyethylene drums, stainless steel totes, or polypropylene flexitanks under nitrogen headspace. Storage at 15°C–30°C is standard; temperatures below 0°C increase viscosity and may cause partial gelation or crystallisation at high concentration, so the solution should be warmed gradually to room temperature before transfer if frozen. Repeated freeze-thaw cycles can produce concentration gradients and are not recommended. At relative humidity above 60%, open transfer is not permissible for oral grades because water uptake dilutes the assay and promotes microbial proliferation. The solution supports microbial growth if diluted and stored at ambient temperature for longer than 24 h; diluted batches intended for oral use should contain a preservative or be used within the same shift. For injectable compounding, the diluted solution must be sterile-filtered and held under validated conditions, typically no longer than 8 h at controlled room temperature unless physicochemical and microbiological hold-time studies support longer intervals. The solution is incompatible with strong oxidising agents such as permanganate and dichromate because the secondary alcohol group is oxidised. It should also be added to calcium-containing admixtures under controlled dilution because calcium lactate solubility is finite; published data for specific calcium-sodium lactate admixture ratios is limited, and in-house compatibility testing is required.
