| HS Code | 980290 |
| Product Name | L-Arginine L-Glutamate |
| Chemical Formula | C11H23N5O6 |
| Molecular Weight | 321.33 g/mol |
| Cas Number | 4320-30-3 |
| Appearance | White crystalline powder |
| Solubility | Freely soluble in water; sparingly soluble in ethanol |
| Ph | 5.5 - 7.5 (1% aqueous solution) |
| Melting Point | Decomposes above 190°C |
| Loss On Drying | ≤ 0.5% |
| Assay | 98.0% - 102.0% on a dry basis |
| L Arginine Content | ~54.2% |
| L Glutamic Acid Content | ~45.8% |
| Nitrogen Content | ~21.8% |
| Storage Conditions | Store in a cool, dry place away from light and moisture |
As an accredited L-Arginine L-Glutamate factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | L-Arginine L-Glutamate is packaged as a white crystalline powder in sealed double polyethylene bags inside a fiber drum, 25 kg net. |
| Container Loading (20′ FCL) | Load L-Arginine L-Glutamate in sealed drums onto pallets, secure for 20′ FCL, protect from moisture, ensure proper ventilation. |
| Shipping | L-Arginine L-Glutamate should be shipped in sealed, moisture-proof containers, protected from light and extreme temperatures. Ensure compliance with local regulations for amino acid salts. Avoid exposure to humidity and incompatible materials. Use appropriate labeling, and handle with standard chemical safety precautions to maintain stability and purity during transit. |
| Storage | Store L-Arginine L-Glutamate in a tightly sealed container in a cool, dry, well-ventilated area away from direct sunlight, moisture, and heat. Avoid contact with strong oxidizing agents. Keep at room temperature unless otherwise specified; refrigeration is not required but consistent conditions prevent caking or degradation. Ensure the container is clearly labeled and inaccessible to children. |
| Shelf Life | Store in a cool, dry place; stable for 2–3 years when sealed, protected from light and moisture. |
L-Arginine L-Glutamate is prepared as a sterile amino acid additive for hospital and home-care parenteral nutrition programs where clinical protocols require arginine delivery with reduced chloride load. The salt is weighed and transferred in an ISO 5 laminar-flow compounding hood under USP <797> single-dose requirements, then dissolved in water for injection at 18–25 °C with magnetic stirring at 200–400 rpm. Complete dissolution is confirmed visually and by turbidimetric measurement below 0.5 NTU. Terminal sterilisation by autoclave is not applied; the glutamic acid moiety undergoes thermally driven lactamisation to pyrrolidone carboxylic acid when exposed to pH below 4.0 at temperatures above 121 °C. Sterile filtration of the reconstituted stock solution through a 0.22 µm PVDF capsule performed in accordance with ISO 13408-1:2008 is the defined manufacturing control. The addition rate to a total nutrient admixture containing crystalline amino acids, glucose, lipids, electrolytes, and trace elements must be validated by benchtop admixture studies; phosphate precipitation with calcium gluconate and magnesium sulfate is a known failure mode when amino acid concentrations and final pH shift outside the range of 5.5–6.5. Published compatibility data for this exact salt in commercial 3-in-1 lipid emulsions are limited; when no supplier-specific admixture matrix is available, the compound should be added to the amino acid-dextrose compartment prior to lipid introduction. Users must record calcium, magnesium, and phosphate milliequivalents per litre, and apply a validated sterility test per USP <71> for every production lot. Residual moisture in the raw material influences compounding accuracy because the anhydrous salt may pick up moisture above 60 % relative humidity; the raw material should be stored in steam-impermeable aluminium laminates with desiccant and checked by USP <731> before weighing. The maximum addition limit is not defined by a pharmacopoeial monograph; therefore each pharmacy must establish a master formulation record with an upper arginine and glutamic acid daily dose derived from clinical literature, and the final admixture should be assigned a beyond-use date according to the current USP <797> risk category.
Dry powder oral dosage forms containing L-Arginine L-Glutamate as the primary amino acid load exhibit segregation in V-blender and bin-blender operations when the received crystalline powder has a plate-like or needle-like habit and a wide particle size distribution. The salt is delumped through a 20-mesh screen per USP <786> and blended with microcrystalline cellulose PH-102, croscarmellose sodium, and fumed silica in a geometrically ordered addition sequence: silica first, active second, disintegrant third, and filler last. Pre-blending moisture must be controlled below 5.0 % by Karl Fischer titration per USP <921>; if the moisture content exceeds 5.0 %, the powder cakes in the press feed frame and tablet weight variation moves outside the USP <905> acceptance value of 15.0. Compression is performed on a rotary tablet press at main compression force 8–14 kN, precompression force 2–4 kN, and turret speed 30–60 rpm; final tablet hardness is held between 90 N and 180 N. For a 750 mg active strength, the tablet core typically weighs 1,200–1,500 mg; swallowability imposes a formulation boundary that requires cohesive excipients rather than brittle fillers. Sodium stearyl fumarate at 0.5–1.5 % is preferred over magnesium stearate because hydrophobic lubricant films on amino acid particle surfaces can delay dissolution. Dissolution is tested with USP <711> Apparatus 2, 900 mL distilled water, paddle speed 50 rpm, and sampling at 15, 30, 45, and 60 minutes. Because no compendial dissolution monograph for amino acid salts has been harmonized, the method must be validated under ICH Q2(R1) with linearity across 10–120 % of the label claim and recovery between 98 % and 102 %. Dry granulation with roller compaction may be necessary when the salt exceeds 30 % of the core weight; direct compression remains viable only for robust powder blends with bulk density above 0.45 g/cm³. The manufacturing records should not combine this salt with reducing sugars in wet granulation at elevated inlet temperatures because Maillard adducts form between the arginine guanidinium group and reducing aldoses, reducing assayable active and generating colour. Hardness and disintegration per USP <701> should be assessed after 7 days at 40 °C/75 % RH because the salt softens high-humidity-exposed cores; if disintegration exceeds 15 min, the packaging must include HDPE bottles with desiccant or cold-form foil blisters.
In high-density CHO-K1 and CHO-S fed-batch and perfusion processes, L-Arginine L-Glutamate is used to correct arginine exhaustion without adding the chloride burden of L-arginine hydrochloride. The material is dissolved in cell culture water at 18–25 °C, stirred with a low-shear axial impeller at 150–300 rpm for 30–60 minutes, and sterile-filtered through a 0.1 µm PES membrane. The filter pressure differential should remain below 0.35 bar; loading above 50 g/L may exceed the capacity of a 10-inch cartridge and cause premature plugging, although the actual capacity must be confirmed with the filter manufacturer. The buffering action of the glutamate anion reduces the pH drop in concentrated feed solutions, but the feed must not be autoclaved because glutamic acid cyclises to pyrrolidone carboxylic acid below pH 4.0 at 121 °C. In perfusion or fed-batch mode, the addition rate should be matched to cell-specific arginine consumption; regulatory dossiers should demonstrate that residual arginine in the supernatant does not fall below 0.5 mM during the stationary phase. Glutamic acid is not a metabolic substitute for L-glutamine in mammalian nucleotide biosynthesis; glutamate supplies carbon and nitrogen into the TCA cycle but does not donate the side-chain amide nitrogen required for purine and pyrimidine synthesis. Therefore the salt is used as a supplementary nitrogen source rather than a direct glutamine replacement. Endotoxin and bioburden limits adhere to USP <61>, USP <85>, and EP 2.6.7; release panels typically include endotoxin ≤ 0.05 EU/mg, total aerobic count ≤ 100 CFU/g, and absence of Salmonella and Escherichia coli. In chemically defined media, dissolved glucose should be monitored by an immobilised glucose oxidase probe because the amino acid salt can interfere with older colorimetric reducing-sugar assays, producing a negative bias above 5 g/L. Long-term liquid feed stability is limited by oxidative decarboxylation; storage at 2–8 °C in dark glass or single-use bioprocessing bags for 14 days is typical, after which arginine and glutamic acid content are re-assayed by UHPLC with charged aerosol detection.
Leave-on aqueous serums and hair-conditioning emulsions incorporate L-Arginine L-Glutamate in the water phase at 0.5–2.0 wt % for pH control and skin-conditioning function. The salt is dissolved under propeller stirring at 500–800 rpm and 20–30 °C before hydration of carbomer or xanthan gum; post-addition of the salt to a neutralised carbomer gel reduces clarity and thixotropic recovery. The finished formulation pH is adjusted with citric acid or sodium citrate to 5.0–6.0, which keeps glutamic acid above its isoelectric point and maintains electrode-measured pH stability for 90 days at 45 °C. The free amino group of arginine is reactive with aldehyde functional groups; diazolidinyl urea and imidazolidinyl urea preservatives are therefore incompatible, and preservation efficacy must be confirmed per ISO 11930 using Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, and Aspergillus brasiliensis. The preservation challenge test must meet the acceptance criteria specified in Annex B of ISO 11930, with bacterial reduction of at least 3 log within 7 days and fungal reduction of at least 1 log within 14 days. If the formula contains anionic sulfates or olefin sulfonates, the salt is pre-dissolved and added below 40 °C to prevent localised anion-exchange precipitation. Cold-process operations are preferred over high-shear homogenisation because the salt can reduce interfacial tension and shift droplet size distribution; when a high-pressure homogeniser is used, two passes at 600–800 bar are sufficient and a third pass may overemulsify. Photostability testing per ICH Q1B is not required for non-preserved topical forms unless the product is filled in transparent packaging; amber glass or opaque PET remains the standard. The raw material should be designated INCI Arginine Glutamate and a safety dossier compiled under EU Cosmetic Regulation (EC) No 1223/2009, with verification against Annex II prohibitions.
Post-pellet vacuum coating is the preferred addition route for L-Arginine L-Glutamate in monogastric premixes because exposure to dry extrusion heat above 120 °C in the presence of reducing sugars initiates Maillard loss of available arginine. The salt is applied at 0.1–0.5 wt % of complete feed, dissolved or suspended in deionised water, and sprayed onto pellets at 60–70 °C under negative pressure in a vacuum coater. The coating cycle is 15–25 minutes, after which the pellets are cooled to below 30 °C and moisture is reduced to ≤ 12 % before bagging. If the salt is mixed into a meal premix before pelleting, the formulator must remove lactose, glucose, and dextrose from the premix carrier or reduce conditioning temperature to ≤ 85 °C; otherwise furosine and Nε-carboxymethyllysine measured after acid hydrolysis by HPLC will rise, indicating blocked lysine and arginine. The anhydrous salt has a calculated arginine fraction of 0.542 and glutamic acid fraction of 0.458; this conversion factor is used to calculate supplemental digestible amino acid contribution on a dry matter basis. Storage conditions should be held at ≤ 25 °C and ≤ 60 % RH; clumping occurs if the inner bag is left open. Regulatory acceptance in each market must be verified separately; in the European Union, feed amino acids fall under Regulation (EC) No 1831/2003, and an authorisation dossier for the salt itself, not only the constituent amino acids, is required unless national law explicitly permits the salt. Ileal digestibility data for the salt is limited in broilers; published coefficients for crystalline L-arginine and L-glutamic acid should not be applied to the salt without a validated digestibility study. The product must not be mixed with alkaline silage additives or urea-based mineral premixes because the ammonium equilibrium shifts and releases detectable free ammonia in closed silos.
Low-pH enteral and oral nutritional supplements intended for adult disease-related malnutrition or perioperative support can use L-Arginine L-Glutamate as an arginine source, but the free glutamic acid generated after acidification has a well-defined solubility minimum. The isoelectric point of glutamic acid is 3.22, and its aqueous solubility at 20 °C is approximately 8.6 g/L; the salt is freely soluble in water at neutral pH, but when the finished formula is adjusted to pH 3.5–4.5 for microbiological stability, glutamic acid may crystallise if the target addition exceeds the saturation limit in the continuous phase. Formula developers therefore add the salt to the neutral protein-carbohydrate base before final acidification, not to the acidified buffer tank. The product can be sterilised by UHT at 135–150 °C for 5–15 seconds only after establishing that glutamic acid residual content does not fall below assay specification, because low pH combined with high temperature promotes lactam formation. Enteral formulations carrying medical food claims in the United States must comply with the medical food definition in 21 U.S.C. 360ee(b)(3) and applicable clinical nutrition labelling rules; in the European Union, foods for special medical purposes are covered by Regulation (EU) No 2016/128. Viscosity build after UHT should be monitored with a Brookfield rotational viscometer at 50 rpm; significant viscosity drift indicates protein aggregation involving the amino acid salt, requiring a reduction in mineral fortification or a change in homogenisation pressure. Batch records must document osmolality per USP <785> and pH after cooling to 25 °C; hypertonic formulas above 500 mOsm/kg water may require careful sip feeding or tube dilution. Published comparative data for this exact salt in low-pH enteral matrices are limited; benchtop factorial studies are recommended before production scale-up.
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L-Arginine L-glutamate is a 1:1 stoichiometric salt of L-arginine and L-glutamic acid. The standard production model is an anhydrous crystalline powder; a separate lyophilized low-endotoxin grade is available for cell-culture applications where bioburden control is required. The anhydrous form is described by the molecular formula C11H23N5O6 and a molar mass of 321.33 g/mol; the assigned CAS registry number is 4320-30-3. Since no harmonized monograph for the salt appears in Ph. Eur. or USP-NF, the release specification is constructed from the separate monographs for L-arginine and L-glutamic acid, supplemented by a counterion stoichiometry test and a chloride limit. The material is designated as a composite amino acid salt rather than a simple arginine source.
Bulk packaging is typically a 25 kg fiber drum with a double polyethylene liner. Recommended storage is 15–25 °C in a dry environment; after opening, the material is transferred to a desiccated cabinet under nitrogen purge if consumption extends beyond 72 hours. Exposure above 60% relative humidity leads to visible caking and changes in powder flow.
The specification framework for the anhydrous model includes release limits that are representative of a cell-culture-grade product and are not a pharmacopoeial monograph. Because the salt contains two ionisable amino acids, single-component titration with perchloric acid is not sufficient to quantify both species. The release protocol therefore combines assay, chloride testing, infrared identity, and specific optical rotation or enantiomeric purity. Batch-to-batch variance in counterion ratio is monitored by ion chromatography because small deviations alter the delivered molar ratio in final media.
| Test | Release limit | Analytical procedure |
|---|---|---|
| Appearance | White or almost white crystalline powder | Visual inspection |
| Identification | Infrared spectrum concordant with reference | Ph. Eur. 2.2.24 |
| Assay, anhydrous basis | 98.5–101.0% | Perchloric acid titration |
| Loss on drying | ≤0.5% | USP <731> |
| Residue on ignition | ≤0.1% | USP <281> |
| Chloride | ≤0.02% | Ion chromatography |
| Sulfate | ≤0.02% | Ion chromatography |
| Iron | ≤10 ppm | ICP-OES |
| Endotoxin, cell-culture grade | <0.5 EU/mg | USP <85> |
Enantiomeric purity is controlled by chiral ligand-exchange HPLC with UV detection at 195 nm; the sum of D-arginine and D-glutamic acid is limited to ≤0.5% area. Residual solvents are controlled under Ph. Eur. general chapter 5.4. Elemental impurities are managed under ICH Q3D for parenteral and cell-culture grades; the oral powder grade follows applicable regional food additive requirements.
In aqueous solution, L-arginine L-glutamate dissociates into L-arginine cations and L-glutamate anions. The solution pH is controlled by the pKa values of the constituent amino acids: L-glutamic acid has carboxyl pKa values near 2.19 and 4.25 and an amino pKa near 9.67; L-arginine has a carboxyl pKa near 2.17, an amino pKa near 9.04, and a guanidinium pKa near 12.48. The mutual neutralization produces a solution that is close to neutral, but the exact pH depends on concentration, temperature, and dissolved carbon dioxide. Published data for this specific configuration is limited; therefore, process pH adjustments are verified by calibrated potentiometric measurement rather than predicted from pKa values alone.
Dissolution is rapid in water at room temperature. In media preparation, the salt is added before heat-labile components because it does not require acidification; this is a processing difference from L-arginine base, which can raise pH and requires stepwise addition under pH control. The glutamate moiety also contributes to buffering capacity in the weakly acidic range, which is useful in basal media that are held at 4 °C for extended periods before filtration.
In a 2-L stirred-tank bioreactor configured for CHO-K1 seed expansion, the basal medium may be prepared with L-arginine L-glutamate to supply 0.8 mM L-arginine and 0.8 mM L-glutamic acid. The osmotic contribution is approximately 1.6 mOsm/L when the salt is added at 0.8 mM. L-Glutamine is added separately at 4 mM; the salt does not contain the amide nitrogen required for rapid proliferative demand.
The replacement of L-arginine hydrochloride with L-arginine L-glutamate changes the anion load and the arginine mass fraction. Each gram of L-arginine hydrochloride delivers approximately 0.827 g L-arginine and 0.168 g chloride. In contrast, each gram of L-arginine L-glutamate delivers approximately 0.542 g L-arginine and 0.458 g L-glutamic acid, with no chloride. This distinction matters in total parenteral nutrition admixtures where chloride load is constrained to avoid hyperchloremic metabolic acidosis.
| Arginine source | Arginine mass fraction (g/g) | Co-delivered species | Chloride mass fraction (g/g) | Primary formulation difference |
|---|---|---|---|---|
| L-Arginine base | 1.000 | None | 0.000 | Strongly basic; raises pH |
| L-Arginine hydrochloride | 0.827 | Hydrochloride | 0.168 | Standard chloride salt |
| L-Arginine L-glutamate | 0.542 | L-Glutamic acid | 0.000 | Chloride-free dual amino acid salt |
Substitution of L-arginine HCl by L-arginine L-glutamate removes 0.168 g chloride per gram of former salt but also reduces the arginine content per gram by 0.285 g. The formulation therefore requires a mass correction factor of 1.53 to deliver the same arginine dose. The glutamate moiety adds anionic charge that may alter the buffer capacity of the admixture; magnesium and calcium compatibility is revalidated by visual precipitation tests and pH stability testing after substitution.
Parenteral amino acid solutions are formulated to maintain a defined anion gap and osmolality. L-arginine L-glutamate is not interchangeable with L-ornithine L-aspartate in hepatic encephalopathy protocols: the former delivers arginine and glutamate, while the latter delivers ornithine and aspartate. The urea-cycle roles differ, and published data for L-arginine L-glutamate in that specific indication is limited.
L-Glutamic acid and L-glutamine are metabolically distinct. L-arginine L-glutamate delivers the glutamate skeleton but not the amide nitrogen of glutamine. In fast-growing hybridoma and myeloma lines, glutamine demand often exceeds endogenous synthesis, and direct substitution of the salt for glutamine results in growth arrest. Standard media formulation practice maintains L-glutamine as a separate component at 2–6 mM. Published data for this specific configuration is limited; therefore, spent-medium glutamine measurement by enzymatic assay is recommended before removing free L-glutamine from a formulation.
In culture media, L-arginine L-glutamate is used as an alternative to L-arginine HCl when the chloride load from sodium chloride, potassium chloride, and calcium chloride is already high. The product offers a chloride-free arginine input and supplies L-glutamic acid that can enter the tricarboxylic acid cycle via α-ketoglutarate. This property is relevant in fed-batch processes where ammonia accumulation above 5 mM is associated with reduced specific productivity.
For direct compression and dry-blend operations, the product is milled through a 0.5 mm screen fitted with a dust extraction unit to reduce agglomerates. The milled powder is blended in a low-shear mixer at 12–15 rpm for 10–15 minutes. The material is incompatible with strong oxidizing agents and should be isolated from amine-based additives unless compatibility is confirmed by forced degradation testing.
Release testing for the lyophilized grade uses Karl Fischer titration rather than loss on drying because the matrix is hygroscopic. Water content is controlled to ≤1.0% for cell-culture applications. The final container closure is tested for seal integrity under vacuum decay, and retention samples are held at 25 °C for ongoing stability evaluation.
