| HS Code | 921651 |
| Chemical Name | L-valine |
| Chemical Formula | C5H11NO2 |
| Molar Mass | 117.15 g/mol |
| Iupac Name | (2S)-2-amino-3-methylbutanoic acid |
| Cas Number | 72-18-4 |
| Melting Point | 315 °C (decomposes) |
| Solubility In Water | Soluble (85 g/L at 20 °C) |
| Density | 1.23 g/cm³ |
| Pka | 2.32 (carboxyl), 9.62 (amino) |
| Isoelectric Point | 5.96 |
As an accredited Valine factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Valine, 500 g, packaged in a sealed amber glass bottle with tamper-evident cap, labeled with purity and hazard information. |
| Container Loading (20′ FCL) | Valine loaded in 20′ FCL: 20-foot full container load, secured pallets, moisture-proof packaging, labeled, stable, safe transport. |
| Shipping | Valine is shipped as a white crystalline powder in sealed, moisture-proof drums or bags to prevent contamination. It is generally non-hazardous under normal transport conditions, but should be kept cool and dry. Proper labeling, handling documentation, and avoiding dust inhalation are required during shipping. |
| Storage | Store valine in a tightly sealed container in a cool, dry, well-ventilated area, away from direct sunlight, moisture, and incompatible substances such as strong oxidizers. Keep at room temperature, protected from humidity and extreme heat. Ensure the container is clearly labeled and inaccessible to children or pets. |
| Shelf Life | Valine’s shelf life is typically 2–3 years when stored sealed, cool, dry, and protected from light. |
In broiler and swine feed mills, L-valine is not a direct replacement for soybean meal-bound valine because crystalline amino acid absorption outpaces intact-protein digestion, shifting postprandial plasma amino acid peaks and altering the first-limiting amino acid sequence at the ileum. In low-crude-protein phase-feeding programs, formulators adjust standardized ileal digestible valine-to-lysine ratios to 77–82% for broiler grower diets and approximately 68–72% for nursery piglets based on published dose-response trials; crystalline feed-grade valine is added at 0.3–1.5 kg/t of finished feed, depending on basal grain matrix and synthetic amino acid loading. The EU authorization for L-valine produced by fermentation falls under Regulation (EU) No 348/2012, within the wider feed additive framework of Regulation (EC) No 1831/2003; feed hygiene on-site is governed by Regulation (EC) No 183/2005. Production integration typically uses a stainless-steel micro-dosing system with 5–25 kg capacity discharging into a twin-ribbon mixer at 15–25 rpm; a low-dusting grade is preferred because crystalline valine dust below 100 µm can escape through baghouse filters and increase cleaning frequency on rotary airlock seals. Terminal finished product types include complete feed, concentrate compound feed, and mineral-vitamin premixes for broiler, turkey, piglet, and aquafeed; no numerical maximum is fixed in the EU authorization, but overdosing beyond 1.5 kg/t in low-protein broiler rations creates branched-chain amino acid antagonism, particularly feed intake depression and lysine dilution, which is an operational boundary rather than a regulatory threshold.
| Compliance point | Standard or code | Process observation |
|---|---|---|
| Feed additive register | Regulation (EU) No 348/2012 | L-valine produced by fermentation; nutritional additive functional group for all animal species |
| Feed hygiene | Regulation (EC) No 183/2005 | HACCP-based dust containment during micro-dosing |
| Amino acid assay | ISO 13903:2005 | Ion-exchange chromatography with ninhydrin post-column derivatization |
| Legal framework | Regulation (EC) No 1831/2003 | Zootechnical and nutritional additive placement; no maximum residue limit for valine itself |
Aqueous L-valine solubility at 25°C is approximately 58 g/L, which is not the primary constraint in ready-to-use parenteral nutrition; instead, valine participates in amino acid–phosphate interactions and pH drift during terminal sterilization at 121°C for 15 min. In crystalline amino acid injection manufacturing, the L-valine monograph of USP-NF and the corresponding European Pharmacopoeia monograph apply; drug product manufacture is governed by 21 CFR 210 and 21 CFR 211, while admixture compounding follows USP <797>, and elemental impurity screening follows ICH Q3D. Formulation addition ratio in concentrated crystalline amino acid solutions places valine at 4.5–7.0 g per 100 g of total amino acids; final concentration in a compounded admixture depends on the dilution volume of dextrose and lipid emulsion but is not fixed by a single pharmacopoeial value. The production process moves through a water-for-injection loop maintained at total organic carbon below 500 ppb and conductivity below 1.3 µS/cm at 25°C, then blends crystalline L-valine with other amino acids, salts, and trace elements in a closed stainless-steel reactor, followed by sterile filtration through a 0.22 µm polyethersulfone membrane and filling into non-polyvinyl chloride multilayer bags. Terminal finished product types include 8%, 10%, and 15% crystalline amino acid solutions, central parenteral admixtures, and peripheral parenteral nutrition; glucose-free amino acid stock solutions are stored separately from dextrose until final admixture to avoid Maillard reaction, and final admixtures should be used within 24 h at controlled room temperature to avoid pH drift caused by lipid hydrolysis.
In Chinese hamster ovary CHO DG44 and CHO-K1 monoclonal antibody platforms, L-valine is a conditional-stable amino acid that limits cell-specific productivity when the branched-chain amino acid ratio drifts outside clone-specific feeding windows; the material is delivered as a dry-powder basal medium component or as an acidified feed concentrate. Regulatory compliance for this use is anchored to USP <1043> ancillary materials, ICH Q5A viral safety, and ICH Q5D cell substrate characterization; the raw material is typically released with a bacterial endotoxin limit below 2.5 EU/g and a bioburden count below 10 CFU/g. Formulation addition ratios are expressed in millimolar working concentrations rather than weight-per-weight because final alkalinity and osmolality control dominate the process: basal media generally maintain valine in the range of 0.1–0.9 mmol/L, while enriched feed supplements can bring peak working concentrations to 0.5–1.5 mmol/L after bioreactor dilution. Production-scale powder processing uses a pin mill for deagglomeration, followed by a tumble blender with 70–80% fill capacity and controlled humidity below 40% RH; dissolution is completed in water for injection under low-shear mixing at 4–8°C, pH-adjusted to 2.5–3.5 for concentrated feeds, and sterilized through a 0.1 µm tangential-flow filtration membrane. Terminal product forms include CHO basal media, fed-batch feeding supplements, and perfusion media for upstream bioprocessing; the operational limitation is that concentrated L-valine stock solutions should not be co-mixed with bicarbonate-containing buffers before dilution because carbon dioxide degassing can alter pH and precipitate divalent cations.
A 2:1:1 L-leucine:L-isoleucine:L-valine dry blend imposes a valine mass share of 1.0 part per 4.0 parts total branched-chain amino acids; in a 5 g BCAA serving this corresponds to 1.25 g L-valine, while alternative positions such as 1:1:1 or 4:1:1 shift the valine contribution according to clinical or endurance claims. The raw material is released against the USP-NF L-Valine monograph and, where specified, finished lots are screened under NSF Certified for Sport or LGC Informed Sport protocols; sports nutrition labeling in the United States follows 21 CFR 101.36 and dietary supplement current good manufacturing practice under 21 CFR 111. Manufacturing of instantized powders proceeds through a high-shear mixer with 1.0–2.5 wt% sunflower lecithin or medium-chain triglyceride to control dust and improve wetting, followed by fluidized-bed agglomeration with inlet air at 55–65°C and dew point 4–8°C, then sieving to retain particles between 80 µm and 600 µm. Terminal finished product types include ready-to-mix BCAA powders, effervescent tablets, clear protein waters, and pre-workout shots; process boundaries are defined by the Maillard reaction between free valine and reducing sugars under thermal sterilization above 110°C, making retort-sterilized clear beverages unsuitable unless the matrix is protein-free and non-reducing. Dissolution of the agglomerated powder in 350 mL water at 20°C should exceed 90% within 120 s under paddle agitation at 100 rpm; published data for valine-only dissolution in finished ready-to-drink beverages is limited, so specification transfer from dry powder to liquid lines requires stability-specific validation.
In pharmaceutical intermediate synthesis, L-valine is not only a peptide building block but also the esterifying moiety in the antiviral prodrug valacyclovir, where the L-valine ester of acyclovir raises oral bioavailability over the parent nucleoside. The raw material and its derivatives are governed by ICH Q7 for active pharmaceutical ingredients, ICH Q3C for residual solvents, and the specific pharmacopoeial monograph for L-valine; N-protected Fmoc-L-valine used in solid-phase peptide synthesis is supplied with residual solvent and dipeptide impurity profiles because incomplete coupling leaves des-valine deletion sequences that are difficult to separate. In solid-phase peptide synthesis, Fmoc-L-valine is charged at 3–4 molar equivalents relative to resin substitution, typically 0.3–0.5 mmol/g, with activation by HBTU and DIPEA in DMF; coupling efficiency is monitored by Kaiser or chloranil test, and a recoupling step with 2 equivalents is required for sterically hindered valine residues because β-branching slows acylation kinetics. Downstream production uses a jacketed solid-phase synthesis reactor with 0.5–50 L working volume, argon or nitrogen inerting, and 20% piperidine in DMF for Fmoc removal; cleavage from the resin with a trifluoroacetic acid/triisopropylsilane/water cocktail proceeds at 20–25°C for 2–4 h, followed by cold ether precipitation. Terminal product types include custom therapeutic peptides, peptide conjugates, and valine ester prodrug intermediates for antiviral APIs; for L-valine methyl ester hydrochloride, methanol is controlled as an ICH Q3C Class 2 residual solvent at 3000 ppm. The operational boundary is its hygroscopicity above 60% RH, requiring sealed storage and nitrogen-blanketed dispensing, and the material should not be milled in contact with iron-based equipment because acid chloride residues can generate metal contamination.
In leave-on scalp serum and heat-protective conditioner manufacture, L-valine functions primarily as a skin and hair conditioning agent; it is not a film-forming polymer and does not provide thermal protection on its own, so formulators pair it with cationic polymers and hydrolyzed proteins to improve combing force under hot air exposure. The ingredient is listed in the European Commission CosIng database and finished products are placed on the market under Regulation (EC) No 1223/2009; raw material purity follows the USP-NF L-Valine monograph or the European Pharmacopoeia alternative, with microbial limits aligned to ISO 17516:2014. Addition ratio in leave-on emulsions is generally 0.1–1.0 wt%; levels beyond 2.0 wt% are not justified by hair-conditioning efficacy and can depress emulsion viscosity by competing with polymeric thickeners for water hydration. Production is typically a cold process: L-valine is dissolved in the water phase at 20–25°C before pH adjustment to 4.5–5.5, then added to the oil phase under propeller stirring at 300–800 rpm; avoidance of temperatures above 45°C is recommended when the formula contains reducing sugars or fragrance aldehydes because Schiff base or Maillard discoloration can occur over shelf life. Terminal finished product types include rinse-off and leave-on conditioners, scalp tonics, and hair masks; published data for valine-specific hair fiber penetration in cosmetic vehicles is limited, and the claim set should remain conditioning and antistatic rather than structural repair.
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Valine, as the commercial L-isomer, is a nonpolar aliphatic branched-chain amino acid with CAS registry number 72-18-4, molecular formula C5H11NO2, and molecular mass 117.15 g/mol. The product is supplied as a white crystalline powder obtained by direct fermentation of dextrose or sucrose using metabolically engineered strains of Corynebacterium glutamicum, followed by ultrafiltration, cation-exchange chromatography, activated carbon treatment, evaporative crystallization, and fluidized-bed drying. Compendial models include USP-NF, Ph.Eur., JP, FCC, and AJI grades for parenteral, cell-culture, and food use, while feed-grade material is released under national feed-additive registrations. L-Valine is distinguished from L-leucine and L-isoleucine by a higher aqueous solubility of 88.5 g/L at 25 °C and by its isopropyl side chain; this difference alters carrier-mediated transport affinity, crystalline powder handling, and metabolic fate. Product selection is therefore governed by purity, residue-on-ignition, chloride, sulfate, iron, heavy-metal, and endotoxin burden rather than by a difference in primary amino acid structure.
Only the L-enantiomer is effective in mammalian amino acid metabolism; D-valine is not quantitatively acylated by human aminoacyl-tRNA synthetases and is not a substitute in parenteral nutrition. Optical rotation in 6 N hydrochloric acid at 20 °C is therefore the referee identity marker, typically between +26.5° and +29.0° for L-valine. In industrial handling, this is not a single product model but a family of grades that differ by the limits imposed on sulfate, chloride, iron, heavy metals, endotoxin, water content, and residue on ignition.
Fermentation is conducted under aerobic fed-batch conditions with dissolved oxygen maintained above 20% saturation; ammonia is used for pH control and supplies part of the nitrogen source. Because valine is a neutral amino acid, downstream purification exploits its retention on strong acid cation-exchange resins, followed by ammonia elution, neutralization, evaporation crystallization, and vacuum drying. This route separates L-valine from charged fermentation residues and from other neutral species by pH-step elution and crystallizer seed-bed control. In production-scale purification, residual sulfates from broth neutralization are a common batch-to-batch variable. Activated carbon decolorization and nanofiltration reduce protein and endotoxin loads before crystallization. Vacuum fluidized-bed drying lowers final moisture to below 0.3% but can cause crystal attrition and increase fines below 100 µm, which affects flow into tablet press dies or volumetric screw feeders. Crystallizer design and seed-bed control are adjusted to keep fine-particle carryover below internal limits; exact acceptance limits are equipment-specific.
Pharmacopoeial L-valine is controlled by the USP monograph; assay on the dried basis is 98.5–101.5%, loss on drying is ≤0.5% by USP 731, residue on ignition ≤0.1% by USP 281, chloride ≤0.05%, sulfate ≤0.03%, iron ≤0.003%, and heavy metals ≤15 µg/g by USP 231. The specific rotation test uses c=8 in 6 N HCl at 20 °C; the acceptance band is +26.5° to +29.0°. These limits are tighter than typical feed-grade material, for which moisture may be controlled at ≤1.5% and assay at ≥98.0% on dry matter, with fermentation-derived sulfate and biomass residual limits set in the registration dossier. In parenteral and cell-culture applications, batch release is additionally constrained by bioburden, endotoxin, and particulate matter; filtration of the final bulk solution through a 0.2 µm sterilizing-grade filter is common before aseptic filling. Published side-by-side particle-size limits across pharmacopoeial and feed-grade L-valine are limited; most manufacturers define sieve fraction limits in quality agreements tied to specific filling or dosing equipment.
| Parameter | USP L-Valine Limit | Test Method |
| Assay, dried basis | 98.5–101.5% | USP monograph |
| Specific rotation [α]D20 | +26.5° to +29.0° | USP 781 |
| Loss on drying | ≤0.5% | USP 731 |
| Residue on ignition | ≤0.1% | USP 281 |
| Chloride | ≤0.05% | USP 221 |
| Sulfate | ≤0.03% | USP 221 |
| Iron | ≤0.003% | USP 241 |
| Heavy metals | ≤15 µg/g | USP 231 |
For cell-culture and parenteral use, the relevant product category is often designated as endotoxin-controlled or cell-culture grade. Endotoxin acceptance criteria are not harmonized across all monographs; end users commonly set a limit of <0.25 EU/mg or lower for chemically defined media and perfusion buffers. Batch release also includes differential scanning calorimetry or melting behavior to confirm the absence of substantial isomer contamination, since L-valine decomposes near 295–315 °C depending on heating rate without a clean melting point. Assay is commonly performed by titration in anhydrous formic acid or by chromatographic methods; polarimetry remains the referee technique for enantiomeric identity. In feed milling, identity is frequently confirmed by ion-exchange chromatography with ninhydrin detection, with high-performance liquid chromatography after pre-column derivatization used to resolve valine from leucine and isoleucine in reconstructed premixes.
Because the carboxyl pKa is 2.32 and the ammonium pKa is 9.62, the isoelectric point of L-valine is 5.96. At pH 7.4 the molecule is predominantly zwitterionic, with limited lipid solubility and low passive membrane permeability. Aqueous solubility at 25 °C is 88.5 g/L. Published low-temperature solubility data are less consistent; cooling crystallization in production therefore relies on seeded beds rather than a linear solubility curve. Compared with L-leucine (24 g/L) and L-isoleucine (34.2 g/L) under identical conditions, L-valine dissolves more readily in aqueous premixes, but its crystals are less compressible than common excipients. Direct compression on rotary tablet presses produces capping and lamination because the crystalline material undergoes brittle fracture rather than plastic deformation; wet granulation in a high-shear granulator or roller compaction is preferred before tableting. In aqueous compounding, dissolution rate is controlled by particle size: crystalline material retained on a 100-mesh sieve dissolves more slowly than micronized material in cold compounding tanks. In feed premises, fine crystals below 100 µm can segregate during pneumatic conveying, while coarse crystals above 500 µm may require pre-dissolution or longer mixing cycles.
| Property | L-Valine | L-Leucine | L-Isoleucine |
| CAS registry number | 72-18-4 | 61-90-5 | 73-32-5 |
| Molecular formula | C5H11NO2 | C6H13NO2 | C6H13NO2 |
| Molecular mass | 117.15 g/mol | 131.17 g/mol | 131.17 g/mol |
| Side chain | isopropyl | isobutyl | sec-butyl |
| Water solubility at 25 °C | 88.5 g/L | 24 g/L | 34.2 g/L |
| pKa1 | 2.32 | 2.36 | 2.36 |
| pKa2 | 9.62 | 9.60 | 9.68 |
| Isoelectric point | 5.96 | 5.98 | 6.02 |
| Specific rotation [α]D20 | +26.5° to +29.0° | +14.9° to +16.0° | +39.5° to +41.0° |
L-valine is incompatible with strong oxidizing agents. In enteral and parenteral compounding, prolonged heating with dextrose causes reducing-sugar conjugation and Maillard browning; sterilization of combined amino-acid/dextrose admixtures is therefore separated from valine-containing amino-acid solutions. The material does not require special pre-drying below 60% relative humidity because the crystalline form is only mildly hygroscopic, but bulk packaging in moisture-barrier sacks is standard for feed-grade products stored in unheated warehouses. Valine is essentially insoluble in nonpolar organic solvents; this property prevents loss during solvent-based extraction processes and is a reason that production isolation uses ion exchange rather than liquid-liquid extraction.
Because L-valine, L-leucine, and L-isoleucine compete for the L-type amino acid transporter 1 (LAT1), substitution of one branched-chain amino acid for another is not stoichiometrically neutral. In standard cell culture media, Dulbecco’s Modified Eagle Medium contains 94 mg/L L-valine, Eagle’s Minimal Essential Medium contains 46 mg/L, and RPMI 1640 contains 20 mg/L. These concentrations are balanced against leucine and isoleucine to prevent transporter saturation and growth inhibition. In fed-batch CHO processes, concentrated feed solutions may raise bioreactor L-valine to 150–300 mg/L, but the leucine/isoleucine/valine ratio must be retained; published data for valine-specific inhibition thresholds in perfusion hollow-fiber reactors are limited. In parenteral nutrition, L-valine is formulated with L-leucine and L-isoleucine in defined ratios because valine is glucogenic, leucine is ketogenic, and isoleucine is both; this metabolic distinction prevents direct interchange in intravenous amino-acid solutions.
In poultry and swine feed, L-valine is used after lysine, threonine, and methionine constraints are met because it is often the next limiting amino acid in low-crude-protein diets. For broiler starter feeds, breeder digestible valine:lysine recommendations are generally in the range 0.76–0.80, while lactating sow diets often require a standardized ileal digestible valine:lysine ratio near 0.85. The product is added as crystalline L-valine or fermentation-soluble valine; post-pelleting addition is common when pellet mill die temperatures exceed 85 °C, not because valine is thermally fragile but to avoid variable recovery in the conditioner. In these applications, flowability and dusting are operational constraints on pneumatic conveying and volumetric screw feeders. Feed-grade product is commonly assayed by ion-exchange chromatography with ninhydrin detection, with verification by high-performance liquid chromatography after pre-column derivatization; polarimetry is used for identity in compendial release.
DL-valine, produced by chemical synthesis, is a lower-cost alternative for chiral building blocks and certain non-mammalian uses but does not meet USP or Ph.Eur. identity requirements because the D-enantiomer is not utilized by mammalian aminoacyl-tRNA synthetases and can depress polarimetric assay. Valine ethyl ester hydrochloride is a peptide-synthesis derivative and is not interchangeable with free L-valine in cell culture, parenteral nutrition, or animal feed. Residual solvent limits follow USP 467 when alcohol-based crystallization is used; standard storage is in tight containers at controlled room temperature.
