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Strategic B2B Intelligence for Pharmaceutical Procurement Officers & Bioprocessing Formulation Scientists
L-Alanyl-L-Glutamine (CAS Number: 39537-23-0; Molecular Formula: C8H15N3O4), commonly referred to as Alanyl-Glutamine or Sustamine, represents a critical stable dipeptide designed to overcome the biochemical limitations of free L-glutamine. As an essential chemical constituent in modern parenteral nutrition formulations, serum-free cell culture media, and specialized clinical rehydration solutions, global demand for enterprise-grade bulk Alanyl-Glutamine has accelerated at an estimated CAGR of 7.4% across pharmaceutical, biomanufacturing, and clinical health industries.
In traditional liquid clinical formulations and industrial bioreactors, free L-glutamine undergoes rapid spontaneous degradation into toxic ammonia and pyroglutamic acid (5-oxoproline). This instability presents significant manufacturing and therapeutic challenges, including elevated cytotoxicity in cell cultures, shortened product shelf-life, and strict thermal sterilization limitations. By chemically coupling L-alanine with L-glutamine through a stable peptide bond, Alanyl-Glutamine delivers exceptional thermal stability, high aqueous solubility (up to 568 g/L at 20°C, compared to merely 35 g/L for free glutamine), and resistance to heat-degradation during steam autoclaving and prolonged storage.
Commercial-scale adoption of L-Alanyl-L-Glutamine dramatically lowers total cost of ownership (TCO) in CHO (Chinese Hamster Ovary) and BHK cell line upstream processing. By replacing free glutamine, biopharmaceutical enterprises eliminate mid-run toxic ammonium accumulation, increasing monoclonal antibody (mAb) titer yields by up to 22% while extending production batch viability by 72 to 96 hours.
Validated Specifications Compliant with EP, USP, and JP Pharmacopoeial Standards
As a premier wholesale Alanyl-Glutamine supplier and synthetic peptide manufacturer, Gentolex Group enforces stringent quality assurance protocols across batch-scale synthesis. Every production lot is delivered with comprehensive analytical documentation, including 1H-NMR, MS, Chiral HPLC purity reports, and verified trace heavy metal analyses.
| Specification Parameter | Pharmacopoeial Testing Standard | Enterprise Quality Target (Gentolex Grade) |
|---|---|---|
| Chemical Name | IUPAC Standard | (2S)-2-[[(2S)-2-aminopropanoyl]amino]-5-amino-5-oxopentanoic acid |
| CAS Number | Chemical Abstracts Index | 39537-23-0 |
| Assay Purity (HPLC) | EP / USP Monograph | 99.0% to 101.0% (Dry Basis) |
| Specific Optical Rotation [α]D20 | Polarimetry (c=5, H2O) | +9.0° to +11.0° |
| Aqueous Solubility | Dissolution Standard | ≥ 500 g/L in H2O at 20°C (Crystal Clear Solution) |
| Bacterial Endotoxins | LAL Kinetic Chromogenic Test | < 0.05 EU/mg (Injectable Grade Available) |
| Related Substances (HPLC) | Impurity Profiling | Free L-Ala ≤ 0.2%, Free L-Gln ≤ 0.2%, Total Impurities ≤ 0.5% |
| Loss on Drying | Thermogravimetric Analysis | ≤ 0.3% |
| Residue on Ignition / Sulfated Ash | Gravimetric Standard | ≤ 0.1% |
| Heavy Metals (as Pb) | ICP-MS Method | ≤ 5 ppm |
Enabling Superior Results Across Clinical Parenteral Therapeutics, Bioprocessing, and Human Performance
Alanyl-Glutamine serves as an indispensable active pharmaceutical ingredient (API) in ICU clinical care. Hydrolyzed endogenously by tissue peptidases into free L-alanine and L-glutamine, it maintains gut mucosal integrity, reduces systemic inflammatory responses, preserves muscle nitrogen balance, and mitigates hospital stay duration in surgical and post-trauma patients.
In upstream biopharmaceutical operations, dipeptide stability prevents ammonia-mediated toxicity during high-density mammalian cell perfusion runs. Utilizing bulk-supplied Alanyl-Glutamine optimizes nutrient uptake profiles, increases specific cellular productivity, stabilizes protein glycosylation patterns, and ensures consistent quality in recombinant protein biomanufacturing.
Due to its ultra-high electrolyte uptake activation via the Na+-dependent SLC6A19 transporter, Alanyl-Glutamine promotes rapid intestinal fluid absorption. Formulated into premium intra-workout beverages and clinical oral rehydration salts (ORS), it enhances cellular hydration, reduces exercise-induced muscle fatigue, and protects intestinal barrier breakdown under heat stress.
Beyond standard dipeptides, Gentolex Group provides contract development and manufacturing services (CDMO) for specialized N-acetylated and protective group peptide derivatives. Our synthesis lines easily transition from pilot-scale R&D batches to multi-ton industrial outputs with complete supply integrity.
Green Enzymatic Coupling vs. High-Yield Chemical Synthesis Pathways
Historically, the industrial chemical synthesis of L-Alanyl-L-Glutamine relies on coupling N-protected L-alanine (such as Boc-Ala-OH or Z-Ala-OH) with protected L-glutamic acid derivatives or directly with L-glutamine esters in the presence of coupling reagents (EDC/HOBt or DCC). After peptide bond formation, selective global deprotection yields raw Alanyl-Glutamine. While effective, traditional chemical synthesis requires rigorous downstream purification steps (crystallization and preparative chromatography) to eliminate trace racemized diastereomers (D-Ala-L-Gln or L-Ala-D-Gln) and residual organic solvents.
Gentolex Group has invested heavily in next-generation green chemo-enzymatic synthesis platforms. Utilizing engineered aminopeptidases and peptide ligases, L-alanine methyl ester is coupled directly with L-glutamine under mild aqueous conditions (pH 8.0, 25°C). This enzymatic roadmap eliminates harsh organic coupling agents, delivers 100% optical selectivity with zero racemization, significantly reduces carbon footprint, and achieves ultra-low endotoxin specifications suited directly for sterile parenteral manufacturing.
Every commercial lot produced at our 250,000 m² international production base undergoes testing via automated high-performance liquid chromatography (HPLC) equipped with refractive index or evaporative light scattering detectors (ELSD). We guarantee chiral purity exceeding 99.5%, ensuring zero cross-contamination with free amino acids.
Connecting Global Life Science Industries with Dependable cGMP APIs
Gentolex’s fundamental goal is to build structural bridges connecting global life science partners with uncompromised API quality, guaranteed product integrity, and agile supply chain logistics. To date, Gentolex Group serves enterprise procurement accounts in more than 10 countries. Dedicated regional operational centers and strategic representative hubs are established in key markets including Mexico and South Africa, allowing localized handling of regulatory dossiers, customs clearance, and stock buffer management.
An overall factory construction area of 250,000 square meters under international cGMP standard to offer flexible, scalable, and cost-effective raw chemical solutions.
Gentolex offers an extensive range of APIs and intermediates for development studies and commercial applications with cGMP standards from long-term collaborations. Full CTD/DMF documentation supported worldwide.
Complete product line configuration, analytical method validation (ICH Q2(R1)), lab setup consultation, and Finished Dosage Form (FDF) licensing out solutions.
For enterprise clients who prefer avoiding the complexity of dealing with multiple points of contact, we provide tailored procurement services leveraging high-tier chemical supply chains.
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View DetailsKey Procurement, Technical, and Compliance Inquiries Regarding Bulk Alanyl-Glutamine
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