| HS Code | 849437 |
| Product Name | Low calcium peritoneal dialysis solution (lactate) Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Product Type | Pharmaceutical API / Peritoneal dialysis solution |
| Pharmaceutical Grade | Pharma Grade / API Grade |
| Dosage Forms | Tablet, Capsule, Granule, Injection, Oral, Injectable |
| Route Of Administration | Oral, Injectable, Intraperitoneal |
| Active Ingredients | Sodium chloride, sodium lactate, calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate |
| Calcium Concentration | 1.25 mmol/L (low calcium) |
| Lactate Concentration | 40 mmol/L |
| Sodium Concentration | 132 mmol/L |
| Magnesium Concentration | 0.25-0.5 mmol/L |
| Chloride Concentration | 95-96 mmol/L |
| Glucose Concentration | 1.36%, 2.27%, or 3.86% w/v depending on formulation |
| Ph | 5.0-6.5 |
| Osmolarity | 344-483 mOsm/L depending on glucose concentration |
| Physical Form | Sterile aqueous solution |
| Appearance | Clear, colorless to slightly yellow solution |
| Solubility | Miscible with water |
| Sterility | Sterile |
| Pyrogenicity | Non-pyrogenic |
| Storage | Store at 20-25°C; protect from freezing and light |
| Shelf Life | 24-36 months |
| Packaging | Bags, bottles, vials, ampoules, or bulk |
| Indications | Peritoneal dialysis for renal failure, especially when low calcium exposure is desired |
| Contraindications | Hypercalcemia, severe hypermagnesemia, lactic acidosis, severe peritonitis |
| Cas Numbers | 7647-14-5; 72-17-3; 10035-04-8; 7791-18-6; 50-99-7 |
| Regulatory Status | Prescription only |
As an accredited Low calcium peritoneal dialysis solution (lactate) 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.
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Incoming low-calcium lactate-buffered peritoneal dialysis API evaluated in a large-volume parenteral fill-finish suite requires real-time conductivity, pH, and bioburden monitoring before any online dilution or terminal sterilization step is initiated. The solution is received at a lactate concentration of 35 mmol/L and a calcium concentration of 1.25 mmol/L; compounding into single-chamber and twin-bag peritoneal dialysis formats retains sodium at 132 mmol/L, magnesium at 0.25 mmol/L, and chloride between 95 mmol/L and 97 mmol/L, with dextrose monohydrate at 1.5% w/v, 2.5% w/v, or 4.25% w/v. The fill-finish operation is controlled under USP <71> and Ph. Eur. 2.6.1 for sterility, USP <85> and Ph. Eur. 2.6.14 for bacterial endotoxins, USP <790> for visible particulates, and ISO 13485:2016 for device-related quality management. The compounded solution passes through 0.22 µm polyethersulfone sterilizing filters into a Grade C cleanroom line with Grade A unidirectional-air protection, then undergoes terminal sterilization in a superheated water cascade autoclave at 121 °C with an accumulated lethality of F0 ≥ 12 min. Terminal finished product forms are PVC-free multi-chamber polyolefin bags containing 1.5%, 2.5%, or 4.25% dextrose low-calcium lactate peritoneal dialysis solutions.
Inline preparation of bicarbonate/lactate-buffered dialysis fluids from low-calcium lactate API imposes a narrow pH window because dissolved calcium equilibrates with carbonate generated during bicarbonate back-titration. The principal process conflict is local calcium carbonate nucleation when the mixed fluid exceeds pH 7.10 at 25 °C; this occurs most frequently at the first-stage acid-concentrate injection point before full bicarbonate equilibration. A formulation ratio using 25 mmol/L bicarbonate combined with 10–15 mmol/L lactate maintains buffer capacity while keeping calcium at 1.25 mmol/L, sodium at 132 mmol/L, and magnesium at 0.25 mmol/L. Downstream proportioning equipment includes a two-stage volumetric cabinet with conductivity-controlled dilution at 14.0–14.4 mS/cm and a response-corrected pH probe with a <15 s response time. The final mixed fluid is passed through a 0.2 µm sterilizing-grade filter before entering a twin-bag peritoneal dialysis set. Compliance for the proportioning step follows ISO 23500-1:2024 for quality management of dialysis fluids and ISO 23500-5:2024 for final-fluid chemical and microbial thresholds, alongside USP <85> endotoxin limits of <0.25 EU/mL. Terminal finished types are terminally sterilized multi-chamber dialysate bags for low-calcium bicarbonate/lactate peritoneal dialysis regimens.
| Application route | Standard designation | Measured parameter or test condition |
|---|---|---|
| Sterile peritoneal dialysis fill-finish | USP <71>, Ph. Eur. 2.6.1 | membrane filtration, 14-day sterility incubation |
| Dialysate inline mixing | ISO 23500-1:2024, ISO 23500-5:2024 | conductivity 14.0–14.4 mS/cm, endotoxin <0.25 EU/mL |
| Injectable sodium lactate | USP <788>, USP <790> | light obscuration, ≥10 µm and ≥25 µm particle thresholds |
| Oral solid dosage form | USP <2040>, USP <711> | disintegration at 37 ± 2 °C, apparatus 2 at 50 rpm |
Blow-fill-seal production of injectable sodium lactate from low-calcium lactate API requires particulate limits tighter than standard large-volume injectables because late-stage sodium lactate can generate crystallites if hold-time pH drifts above 6.8. The liquid formulation is adjusted to a sodium lactate concentration equivalent to 1/6 M, or 18.7 g/L, with final sodium content at 167 mEq/L. Downstream processing integrates 0.22 µm polyethersulfone prefiltration and 0.2 µm sterilizing-grade filtration before low-density polyethylene blow-fill-seal extrusion at melt temperatures between 170 °C and 190 °C. Terminal sterilization applies an autoclave cycle of F0 ≥ 8 min. The operation is governed by USP <788> Method 1 for subvisible particulates, USP <790> for visible particulates, and ICH Q3D for nickel, chromium, and molybdenum limits from extrusion tooling. Terminal finished product types are 10 mL and 500 mL low-density polyethylene ampoules or flexible polyolefin bags for intravenous sodium lactate electrolyte replacement.
Conversion of a liquid low-calcium lactate API into a compressible solid for tablet, capsule, and granule manufacture begins with vacuum concentration at 40–50 °C, followed by spray deposition onto microcrystalline cellulose or pregelatinized starch at a lactate-equivalent loading of 25–35 wt%. The resulting intermediate is blended into a final direct-compression formulation in which sodium lactate-equivalent content ranges from 2.5 wt% to 8.0 wt% for electrolyte tablets, while chewable calcium lactate pentahydrate grades occupy 20–40 wt% of the tablet mass. Disintegration is controlled under USP <2040> in purified water at 37 ± 2 °C, and dissolution is evaluated by USP <711> apparatus 2 at 50 rpm. The granulation process uses a fluid-bed dryer with inlet-air temperature 55–65 °C, outlet-air temperature 30–40 °C, and final moisture below 1.5% w/w. Because published dissolution-curve data for this specific spray-dried lactate configuration is limited, each production batch is qualified against a release dissolution profile using 900 mL of purified water at 37 ± 0.5 °C. Elemental impurity testing follows ICH Q3D, and residual solvent control follows ICH Q3C. Terminal finished product types are scored oral electrolyte tablets, hard gelatin capsules, and unit-dose oral granules.
Wet granulation of oral rehydration salt sachet blends with low-calcium lactate is used where the lactate component replaces trisodium citrate while maintaining WHO sodium and potassium targets. The addition ratio per litre of reconstituted oral rehydration solution includes sodium lactate at 2.5–3.0 g/L, sodium chloride at 2.6 g/L, potassium chloride at 1.5 g/L, and anhydrous glucose at 13.5 g/L, corresponding to a sodium concentration of 60–75 mmol/L, potassium of 20 mmol/L, chloride of 65–75 mmol/L, lactate of 10–15 mmol/L, and glucose of 75–90 mmol/L. The granulation downstream process uses a high-shear granulator with impeller speed at 200 rpm, chopper speed at 1500 rpm, and wet-mass discharge through a 1.0 mm screen, followed by fluid-bed drying at 55 °C to a moisture content below 0.8% w/w. The finished powder is filled into aluminium laminate sachets under controlled humidity not exceeding 30% RH. Compliance anchors are the WHO oral rehydration salts formulation limits, ICH Q3D for elemental impurities, and ISO 15378:2017 for primary packaging quality management. Terminal finished product types are unit-dose oral rehydration salt sachets for reconstitution to 1 L solution.
Automated peritoneal dialysis cycler proportioning controls low-calcium lactate dialysate delivery through disposable cassette sets, where the incoming API must remain chemically stable during repeated warming cycles at 37 °C and during dwell periods of 4–6 h. The nominal final fluid composition remains sodium 132 mmol/L, calcium 1.25 mmol/L, magnesium 0.25 mmol/L, chloride 95–97 mmol/L, and lactate 35 mmol/L. The cycler performs controlled proportioning with average flow rates between 150 mL/min and 300 mL/min, and the warmed fluid is delivered into the peritoneal cavity through silicone patient lines. Equipment safety and performance is governed by IEC 60601-2-39:2024 for peritoneal dialysis equipment, while fluid quality is maintained under USP <85> endotoxin limits and ISO 13485:2016 process controls. The terminal downstream configuration is a sterile disposable APD cassette set paired with low-calcium lactate peritoneal dialysis solution bags for home and hospital automated therapy.
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Low calcium peritoneal dialysis solution (lactate) Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is a terminally sterilized, nonpyrogenic peritoneal dialysis fluid supplied in PVC-free polyolefin bags with a high-barrier overpouch. The product title includes the phrase “Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable” as a pharmaceutical quality-grade listing; however, the specific dosage form is an intraperitoneal solution, not a solid oral product or intravenous injection. The solution is released in three dextrose monohydrate concentrations—1.5% w/v, 2.5% w/v, and 4.25% w/v—equivalent to anhydrous glucose 1.36%, 2.27%, and 3.86% w/v. Nominal fill volumes are 2000 mL and 2500 mL. The electrolyte composition is sodium 132 mmol/L, calcium 1.25 mmol/L, magnesium 0.25 mmol/L, chloride 96 mmol/L, and lactate 40 mmol/L. The product is not intended for oral administration, tableting, encapsulation, or granulation; the dosage form suffix in the listing refers to the manufacturing site’s pharmaceutical audit status rather than a recognized formulation use for this fluid.
Clinical use is restricted to intraperitoneal administration for continuous ambulatory peritoneal dialysis and automated peritoneal dialysis. In continuous ambulatory peritoneal dialysis, dwell volumes of 2000–2500 mL are exchanged 3–5 times per day; in automated peritoneal dialysis, cycler-delivered volumes and dwell times of 60–120 min are programmed according to the peritoneal equilibration test category. Ultrafiltration is generated by the osmotic gradient between the hypertonic dextrose-containing solution and capillary blood, and the three dextrose strengths provide graduated fluid removal. The low calcium and low magnesium profile remains constant across the dextrose gradients, so ultrafiltration can be increased without simultaneously increasing peritoneal calcium loading.
The manufacturing process uses a continuous blending vessel, 0.22 µm sterilizing-grade membrane filtration, and single-chamber filling before terminal steam sterilization. The liquid is not dried or converted into a powder; therefore, the API listing for tablet/capsule/granule does not correspond to a physical powder form. The product is supplied only as a sterile aqueous solution, and no tablet, capsule, or granule formulation containing peritoneal dialysis solution as an ingredient is recognized in current pharmacopoeial practice. The applicable route is intraperitoneal infusion under a prescription.
Terminal sterilization is performed after filling and sealing. The solution is filtered through a 0.22 µm sterilizing-grade membrane before filling, then subjected to saturated steam sterilization at 121 °C with a lethal rate Fo of not less than 12 min. The single-chamber glucose-containing configuration is held at a low pH before heat exposure to suppress glucose degradation product formation; the release pH is controlled between 5.0 and 6.5. Residual headspace oxygen is minimized by nitrogen flushing because oxidative pathways increase 5-hydroxymethylfurfural and carbonyl stress products. Each batch is released only after sterility testing per USP <71>, bacterial endotoxin testing per USP <85>, and particulate matter analysis per USP <788>. For large-volume parenterals, USP <788> limits particles ≥ 10 µm to not more than 25 particles per mL and particles ≥ 25 µm to not more than 3 particles per mL. The endotoxin release limit applied to each lot is not more than 0.5 EU/mL.
Sterility for terminally sterilized fluids is controlled by parametric release supported by validated load patterns, thermocouple mapping, and biological indicators using Geobacillus stearothermophilus spores. During autoclave qualification, the lower seal area of the 2500 mL bag is treated as the coldest point because large-volume bag corners are slower to reach sterilization temperature. A local temperature fall below 121 °C for more than 60 s in this zone triggers load rejection. The filling line operates under Grade A air supply with Grade B background, and the product is filled at controlled ambient temperature to avoid pre-sterilization dextrose caramelization; the solution is then autoclaved within a defined holding period.
The release specification matrix is summarized in Table 1. Values are nominal release targets; the batch certificate of analysis controls the final disposition because thermal sterilization can shift pH and aldehyde content within the validated range.
| Parameter | 1.5% w/v dextrose monohydrate | 2.5% w/v dextrose monohydrate | 4.25% w/v dextrose monohydrate |
|---|---|---|---|
| Anhydrous glucose equivalent | 1.36% w/v | 2.27% w/v | 3.86% w/v |
| Theoretical osmolarity | 346 mOsmol/L | 396 mOsmol/L | 484 mOsmol/L |
| Sodium | 132 mmol/L | 132 mmol/L | 132 mmol/L |
| Calcium | 1.25 mmol/L | 1.25 mmol/L | 1.25 mmol/L |
| Magnesium | 0.25 mmol/L | 0.25 mmol/L | 0.25 mmol/L |
| Chloride | 96 mmol/L | 96 mmol/L | 96 mmol/L |
| Lactate | 40 mmol/L | 40 mmol/L | 40 mmol/L |
| pH release window | 5.0–6.5 | 5.0–6.5 | 5.0–6.5 |
Osmotic ultrafiltration is a function of the dextrose concentration gradient across the peritoneal membrane, dwell time, and membrane hydraulic conductance. The 4.25% dextrose monohydrate solution creates a higher initial crystalloid osmotic gradient and therefore produces faster ultrafiltration in the first 60–120 min of a dwell; the 1.5% solution is closer to isotonic and may produce net fluid reabsorption after prolonged dwells because glucose absorption dissipates the osmotic gradient. In automated peritoneal dialysis, the 4.25% solution is typically reserved for a single daily short dwell to manage volume overload, while the 1.5% and 2.5% solutions are used for longer or overnight cycles. Fill volumes of 2500 mL increase intraperitoneal hydrostatic pressure and may be poorly tolerated in patients with hernias, abdominal leaks, or compromised respiratory mechanics; a fill volume reduction to 2000 mL is indicated when dyspnea or early drain pain occurs.
The product’s fixed electrolyte composition means ultrafiltration prescriptions do not require recalculation of calcium mass transfer. With a dialysate calcium of 1.25 mmol/L, the diffusive gradient typically favors neutral or negative calcium balance in patients with serum ionized calcium above this value; net calcium balance must be interpreted with the ultrafiltration rate because convective calcium loss adds to diffusive loss. Patients on automated peritoneal dialysis who are high transporters absorb glucose rapidly and may have poor ultrafiltration with the 1.5% version; their prescriptions may require a shift to the 2.5% or 4.25% version, or the use of icodextrin for the long dwell. Low transporters maintain ultrafiltration with lower dextrose strengths and are at risk of sodium sieving during short dwells; the fixed sodium concentration of 132 mmol/L should be considered because sodium sieving may transiently lower the drain sodium concentration.
Compared with standard-calcium lactate peritoneal dialysis fluid, the two operational differences are the reduction of calcium from 1.75 mmol/L to 1.25 mmol/L and magnesium from 0.75 mmol/L to 0.25 mmol/L. This formulation is selected when the patient is receiving calcium-containing phosphate binders or active vitamin D analogs, because a positive peritoneal calcium balance promotes vascular calcification. The lower magnesium concentration is used when serum magnesium is at or above the upper reference interval. The product does not remove phosphate independently; phosphate clearance depends on diffusion and convection across the peritoneal membrane during the dwell and drain.
Compared with acetate-buffered peritoneal dialysis fluids, the lactate buffer avoids the direct peritoneal vasodilation and pro-inflammatory response historically associated with acetate accumulation. Lactate is absorbed from the peritoneal cavity and metabolized in the liver and skeletal muscle to bicarbonate; the buffering effect is therefore delayed relative to a direct bicarbonate-containing solution. In patients with severe hepatic failure or lactic acidosis, a bicarbonate-buffered multi-chamber fluid may be preferred because the metabolic conversion of lactate is impaired.
Compared with multi-chamber bicarbonate/low-calcium solutions, the single-chamber lactate product has a lower release pH and may carry a higher glucose degradation product burden because glucose and lactate are co-sterilized. Multi-chamber systems keep glucose in a separate chamber at pH 3.0–3.5 before mixing, which reduces 3-deoxyglucosone, glyoxal, and methylglyoxal. For the single-chamber lactate product, residual aldehyde concentrations are controlled through pH adjustment, nitrogen flushing, and validated sterilization load patterns; however, the single-chamber format inherently exposes the glucose to higher thermal stress than a dual-chamber separation format.
Package compatibility is specified as PVC-free, DEHP-free polyolefin or polypropylene-based bags with high-barrier overpouch. The use of a PVC-free structure avoids plasticizer migration, which is relevant to pharmaceutical-grade parenteral packaging even though aqueous peritoneal dialysis fluids have lower lipophilicity than intravenous lipid emulsions. Leachables characterization follows USP <661.1> and USP <1663>, with extraction conditions simulating autoclave and accelerated storage temperatures. Oxygen transmission through the overpouch is controlled to less than 0.5 cm³/(m²·d) for high-barrier configurations, although end-user storage conditions must not exceed the labeled temperature range.
Bicarbonate-containing additives are not to be admixed before use; the resulting pH increase precipitates calcium carbonate and magnesium carbonate. If calcium or magnesium supplements are added, compatibility must be validated by visual inspection and particulate count per USP <788>. The product must not be frozen because dextrose crystallization can compromise bag integrity, and storage should remain between 15 °C and 30 °C in the overpouch. After removal from the overpouch, the solution should be used promptly; opened bags are single-use and must not be stored for later instillation.
In long-dwell clinical applications, the low-calcium lactate glucose solution is not interchangeable with icodextrin peritoneal dialysis solution. Icodextrin is a glucose polymer with a weight-average molecular weight of 13,000–16,000 Da and sustains ultrafiltration over 8–16 h by colloid osmotic pressure. The dextrose-based low-calcium lactate fluid is a crystalloid osmotic agent; ultrafiltration peaks early and declines as glucose is absorbed. Prescriptions may therefore combine icodextrin for the long dwell with low-calcium lactate glucose solutions for shorter cycler or daytime exchanges. The two products differ in osmolality, buffer load, and carbohydrate absorption, and should not be substituted without a specific ultrafiltration and metabolic assessment.
Transport and storage validation follows ASTM D4169-22 distribution cycles, including stacked vibration and low-pressure high-altitude simulation. Overpouch seal integrity is verified by methylene blue dye penetration after vacuum and pressure exposure; seal failure is cause for rejection. Because the product is water-filled and heavy, drop tests are performed on 2500 mL bags in secondary cartons; corner seals are the most frequent failure location in flexible parenteral packaging after repeated drops.
| Test or control | Reference standard | Applied specification |
|---|---|---|
| Sterility | USP <71> | No growth after 14 days |
| Bacterial endotoxins | USP <85> | ≤ 0.5 EU/mL |
| Particulate matter | USP <788> | ≥ 10 µm ≤ 25/mL; ≥ 25 µm ≤ 3/mL |
| pH | USP <791> | 5.0–6.5 |
| Osmolality | USP <785> | 346, 396, 484 mOsmol/L by strength |
| Plastic packaging system | USP <661.1> | Polyolefin/PVC-free, DEHP-free |
| Extractables and leachables | USP <1663> | Autoclave and storage extraction profile |
| Distribution simulation | ASTM D4169-22 | No overpouch seal failure |
Routine batch release is performed under a pharmaceutical quality system aligned with 21 CFR Part 210/211 for finished pharmaceuticals and ISO 13485:2016 for the medical-device packaging system where applicable. The product’s listing as “Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable” should not be interpreted as a compendial monograph for solid oral dosage forms. Published data for solid dosage form applications of this particular solution are limited. The only recognized route is intraperitoneal infusion under a prescription.
