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N-Acetyl-L-Proline

    • Product Name N-Acetyl-L-Proline
    • Alias N-Ac-Pro
    • Einecs 629-202-8
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry sales7@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    795739

    Cas Number 16856-18-1
    Molecular Formula C7H11NO3
    Molecular Weight 157.17 g/mol
    Synonyms N-Acetylproline; Acetylproline
    Appearance White to off-white powder
    Solubility Soluble in water
    Melting Point 165-170 °C
    Purity Typically ≥98%
    Chemical Structure Proline ring with N-acetyl group
    Storage Temperature 2-8 °C
    Ph 1 Solution 5.0-7.0
    Iupac Name 1-Acetylpyrrolidine-2-carboxylic acid
    Ec Number 240-888-0
    Usage Research, pharmaceutical intermediate

    As an accredited N-Acetyl-L-Proline factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing The 25g N-Acetyl-L-Proline is packaged in a sealed, amber glass bottle with a tamper-evident cap and clear labeling.
    Shipping N-Acetyl-L-Proline is shipped in sealed, chemical-resistant containers to ensure stability and prevent contamination. It is typically transported under ambient conditions, protected from excessive heat, moisture, and direct sunlight. Compliance with relevant chemical shipping regulations ensures safe and secure delivery. Appropriate labeling and documentation accompany the shipment for identification and handling.
    Storage N-Acetyl-L-Proline should be stored in a tightly closed container, in a cool, dry, and well-ventilated area. Avoid exposure to moisture, heat, and direct sunlight. Keep the container away from incompatible substances such as strong oxidizing agents. For long-term storage, refrigeration (2–8°C) is recommended to maintain stability and prevent decomposition. Clearly label all storage containers.
    Application of N-Acetyl-L-Proline

    Applications of N-Acetyl-L-Proline in Industrial Manufacturing

    N-Acetyl-L-Proline serves as a specialized functional raw material across multiple tightly regulated downstream sectors. Our manufacturing expertise enables consistent quality and full traceability on industrial scale. The following sections provide a detailed overview of established use cases, including formulation parameters, compliance standards, process steps, and end product categories.

    1. Parenteral Nutrition Additives for Injectable Pharmaceuticals

    Leading parenteral nutrition manufacturers incorporate N-Acetyl-L-Proline as a conditionally essential amino acid derivative to meet specific clinical needs for patients with metabolic disorders. Its inclusion improves amino acid profile stability and enhances compatibility within large-volume IV nutrition blends, especially those tailored for neonatal and hepatic applications.

    Industry compliance standards

    • USP-NF (United States Pharmacopeia – National Formulary) injection grade specifications
    • European Pharmacopoeia (Ph. Eur.) monographs relevant to injectable amino acids
    • ICH Q7 GMP for Active Pharmaceutical Ingredients
    • 21 CFR Part 211 (US FDA cGMP for finished pharmaceuticals)

    Typical usage ratio

    • 0.1%–2.5% w/v of total amino acid content in premix solutions, adjusted based on individual amino acid profile optimization and clinical protocol requirements

    Downstream process integration

    • Dissolved at the compounding stage prior to sterile filtration and aseptic filling; follows stringent traceability and documentation through in-process and final batch release testing

    Final product types

    • IV amino acid solutions for parenteral nutrition (including pediatric and hepatic formulas)
    • Specialty nutritional injectables for metabolic and inborn error therapy

    2. Peptide and Peptidomimetic API Synthesis

    Synthetic peptide manufacturers leverage N-Acetyl-L-Proline as a protected N-terminal building block in stepwise solid-phase and solution-phase peptide synthesis. The N-acetyl protection supports precise sequence assembly and minimizes racemization, which is critical for regulatory-compliant production of peptide drugs and diagnostic reagents.

    Industry compliance standards

    • ICH Q11 for API manufacturing process control
    • USP General Chapters <1047> on peptide APIs
    • ISO 9001 certified quality management for API intermediates
    • REACH substance registration for export into the EU

    Typical usage ratio

    • Used equimolar to target proline residues within the peptide chain; typical loading on resin is 0.1–1 mmol per synthesis cycle, determined by peptide sequence length and synthesis scale

    Downstream process integration

    • Introduced during the initiation phase of peptide chain elongation on solid-phase resin or as a solution-phase fragment; followed by standard deprotection, cleavage, and downstream HPLC purification

    Final product types

    • Pharmaceutical peptide APIs (e.g., analogs, enzyme inhibitors, receptor modulators)
    • Synthetic peptide standards and laboratory reagents

    3. Food-Grade Amino Acid Fortification and Flavour Modulation

    Within the functional food and beverage sector, N-Acetyl-L-Proline is utilized as a specialty amino acid precursor to fine-tune organoleptic profiles, mask bitterness, and support protein hydrolysate nutritional enhancement. Major applications include ready-to-drink supplements, medical foods, and flavor systems for plant-based protein products.

    Industry compliance standards

    • FCC (Food Chemicals Codex) for food additive identity and purity
    • Regulation (EC) No. 1333/2008 on food additives in the EU
    • ISO 22000 Food Safety Management System
    • China GB 2760-2014 National Food Safety Standard on Food Additives

    Typical usage ratio

    • 0.02%–0.15% w/w in protein-blend beverages or powder premixes, customized based on protein source type and target taste/aroma attributes

    Downstream process integration

    • Incorporated during wet blending of beverage bases, or directly into dry mix supplements pre-packaging; participates in Maillard and Strecker reactions during controlled thermal processing for flavor adjustment

    Final product types

    • Complete nutrition beverages and medical food drink bases
    • Plant-based protein snacks and instant mixes
    • Customized savory flavorings for specialty food manufacturing

    4. Cell Culture Media Supplementation in Bioprocessing

    Biotechnology and pharmaceutical industries add N-Acetyl-L-Proline as a cell culture medium supplement to support mammalian cell viability and recombinant protein expression. The acetylated form moderates osmotic impact while providing stable proline moieties during upstream process development and clinical biologics manufacturing.

    Industry compliance standards

    • USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
    • ISO 13408 Aseptic Processing of Healthcare Products
    • European Medicines Agency (EMA) GMP for biologicals
    • ISPE Good Practice Guide: Biotechnology Manufacturing Facilities

    Typical usage ratio

    • 0.01–0.2 g/L in basal or feed media, adjusted based on specific cell line nutritive needs and experimental optimization of production titers

    Downstream process integration

    • Dosed into culture media preparation tank prior to sterilization (filtration or autoclave); present throughout batch, fed-batch, or perfusion cultivation cycles

    Final product types

    • Monoclonal antibodies and recombinant proteins
    • Viral vector stocks for gene therapy manufacturing
    • Mammalian cell-based research reagents

    5. Diagnostic and Analytical Reagent Manufacturing

    Producers of clinical diagnostics and chemical analytical kits use N-Acetyl-L-Proline as a reference standard, calibration agent, or as a buffer additive to enhance stability and reproducibility of amino acid analysis. Its defined purity supports batch-to-batch consistency in critical life science analytical workflows.

    Industry compliance standards

    • ISO 13485 Medical Devices – Quality Management for IVD manufacturers
    • CLSI Guidelines for Analytical Reagent Quality (Clinical and Laboratory Standards Institute)
    • EU Directive 98/79/EC on In Vitro Diagnostic Medical Devices
    • 21 CFR Part 820 (Quality System Regulation for Medical Devices)

    Typical usage ratio

    • Used as an internal standard or control at 0.1–5 mM depending on analytical platform (HPLC, LC-MS, enzyme assay kits)

    Downstream process integration

    • Dissolved during reagent buffer formulation, calibration set blending, or lyophilization steps for assay kit lot production; included within QC reference pools for analytical validation

    Final product types

    • In vitro diagnostic reagent kits (amino acid quantification, metabolic analyte analysis)
    • Analytical standards for LC/MS or HPLC-based laboratories
    • Certified reference materials distributed to clinical testing laboratories
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    Certification & Compliance
    More Introduction

    N-Acetyl-L-Proline: Harnessing a Reliable Building Block in Modern Chemistry

    Why Focus on N-Acetyl-L-Proline?

    We have spent decades working hands-on with amino acids and their derivatives, watching industries change, regulations tighten, and scientific standards climb. In this landscape, N-Acetyl-L-Proline stands out as a resource with genuine value for those who care about purity, dependability, and functional performance. Those designing peptide-based pharmaceuticals, advanced synthetic intermediates, and specialty nutrition formulations need a material that goes beyond baseline purity standards while supporting critical reactions with as few complications as possible.

    N-Acetyl-L-Proline, delivered under our trusted model number NApro-1121, carries a chemical representation of C7H11NO3, with a molecular weight of 157.17 g/mol. We never approach this compound solely as another specialty chemical. Its popularity in recent years comes from the sharp rise in custom peptide synthesis and new classes of anti-aging, neuroprotective, and regenerative treatments. Laboratory chemists and project managers commonly cite the stable, well-defined properties of N-Acetyl-L-Proline as key factors in consistent yields and simplified downstream purification.

    Specifications and Batch Quality Consistency

    Every industry has seen what goes wrong when a starting material doesn't meet spec from shipment to shipment. So, we anchor our processes around reproducibility and transparency. Our N-Acetyl-L-Proline typically holds a purity specification not less than 99% by HPLC, with water content under 0.5% by Karl Fischer analysis. Specific rotation reads [α]D20 = -84° to -89° (c=1, H2O), in full agreement with well-documented literature values. Appearance-wise, technicians note the fine, off-white crystalline powder, easy to wet and dissolve, ensuring minimal batch lag and no headaches during pre-mixing.

    Residual solvents get special scrutiny in our processes. We use only pharmaceutical-grade reagents and triple-rinse reactor lines, challenging every batch for acetone, methanol, and acetonitrile. Typical heavy metal levels fall below accepted pharmacopoeia thresholds, confirmed not just once but each quarter with full elemental scans. Quite a few companies overlook these details, but end-users working on clinical trial materials or dietary supplement APIs cannot compromise on such factors.

    Particle size and flowability, often afterthoughts at some plants, receive close monitoring. Tight sieve controls keep >98% of our material under 180 μm, supporting rapid dissolution in most buffered and non-buffered aqueous systems. This smoothens preparative HPLC runs and reduces downstream filtration time—a practical difference felt in daily lab work and industrial reactors alike.

    Comparing N-Acetyl-L-Proline with Other Amino Acid Derivatives

    Not every proline derivative behaves the same, and we have responded to dozens of inquiries about “any proline will do”—only for end procedures to falter due to subtle molecular quirks. Free L-proline, basic and more hydrophilic, sometimes fits rapid cyclization protocols but invites unwanted side reactions when acetyl protection of the amine is necessary. Other N-acylated prolines, such as N-benzoyl or tert-butoxycarbonyl protected versions, layer on bulk and hydrophobicity, making purification longer and more solvent-intensive. Acetylation offers the right balance by capping the reactive site, stabilizing the molecule, and allowing selective hydrolysis without excess chemical baggage.

    Customers sometimes experiment with racemic or ambiguous derivatives—yet, projects demanding moderate to high stereochemical fidelity quickly run up against synthesis roadblocks. We only supply the optically pure L-form. Chiral purity, assessed by enantioselective HPLC, regularly exceeds 99.5%. We have learned this becomes crucial not only for peptide integrity but also for subsequent biological studies, where even minor D-isomer contamination carries regulatory and scientific penalties.

    The difference also shows up in storage and handling. Other proline derivatives, especially those left with reactive amine or carboxyl groups, degrade faster or form sticky aggregates when exposed to normal humidity. N-Acetyl-L-Proline offers a noticeably extended shelf life under dry conditions in sealed containers. In our own storage, we have documented stable, non-clumping product after 18 months at room temperature, outperforming several competing alternatives.

    Applications in Peptide Synthesis and Beyond

    N-Acetyl-L-Proline plays a workhorse role in both solid-phase and solution-phase peptide synthesis. The acetyl protection moderates nucleophilicity, preventing unintended side reactions at the N-terminus during coupling, cleavage, and deprotection cycles. Experienced peptide chemists have come to rely on this derivative during multi-step coupling, especially where proline’s cyclic structure lends rigidity and defined secondary structure to the target peptide. Evidence from published literature and our customers’ routine procedures shows a meaningful drop in byproduct formation compared to unprotected or overprotected proline analogs.

    Recently, the use of this compound has expanded into the design of next-generation peptide drugs that target neurological and fibroproliferative pathways. N-Acetyl-L-Proline’s presence at defined points along the peptide chain contributes to the formation of β-turns and pPII helical conformations, impacting both solubility and binding characteristics. In our direct collaborations with pharmaceutical partners, the use of NApro-1121 frequently correlates with faster process validation and higher patient safety margins due to minimized impurities in the final active ingredient.

    The utility is not confined to pharma. Specialist nutrition manufacturers use N-Acetyl-L-Proline as a substrate in creating stable, palatable functional foods. Its relatively neutral taste and absence of residual organic contaminants make it suitable for medical nutrition supplements and sports rehabilitation blends, where tight control over every dietary constituent matters. Cosmetic manufacturers, in search of skin-repair peptides, leverage the same purity and stereo-selectivity to deliver consistent, regulatory-compliant results.

    Purity and Documentation: Meeting the Gold Standard

    No one can afford surprises or hidden inconsistencies, especially for end-users in pharmaceuticals, clinical diagnostics, and regulated food sectors. Our approach to N-Acetyl-L-Proline reflects this reality on multiple levels. Each lot ships with exhaustive certificates of analysis, including trace-level impurity profiles and batch chromatograms. We maintain full traceability, logging every synthesis step in electronic batch records with secure, time-stamped data.

    Joint audits conducted by our partners routinely review everything from incoming raw material acceptance to in-process controls and environmental monitoring. This hands-on approach addresses questions over residual toxicology, storage stability, and GMP conformity—concerns that grow more intense as agencies scrutinize supply chains. Our own quality management includes routine revalidation of test methods, ongoing stability evaluations, and rapid recall protocols, all intended to pre-empt surprises on our clients’ end.

    Beyond the paper trail, every new batch triggers in-house confirmation of optical rotation, chromatographic purity, and heavy metal content before any product leaves our synthesis suites. This ensures documentation matches reality—something our long-term customers have come to value after bad experiences elsewhere.

    Environmental and Safety Commitments in Manufacturing

    Production of N-Acetyl-L-Proline, like all advanced amino acid derivatives, raises questions about environmental responsibility and worker safety. Here, small oversights add up over time, impacting community trust and regulatory standing. We make it a priority to minimize solvent usage and emissions at the source. Our solvent recovery system, deployed since 2018, captures over 75% of volatile organic content, reducing both cost and landfill burden.

    We adapted integrated closed transfer systems to limit any operator exposure during critical acetylation and crystallization steps. Regular air and wastewater monitoring ensures that our plant runs under emission values much stricter than typical national standards, and we publish summary reports to both our peers and the local community. Worker training focuses on real best practices—like staged acetylation to avoid exothermic surges and cold-room material handling during packaging—to keep everyone safer across every production shift.

    Evaluating the Value of Manufacturer Experience

    Having managed every step from lab-scale synthesis to metric ton production lots, we understand each point at which short-term savings can lead to long-term headaches for the user. Some manufacturers pursue aggressive price targets by loosening controls or reducing analytical scrutiny. We know, from working with critical path projects, that shortcuts in amino acid manufacture show up far down the line—in missed specifications, regulatory headaches, and product recalls. Users typically see initial savings turn into higher costs through troubleshooting and rejected batches.

    Our direct involvement and willingness to validate process improvements, invest in robust purification steps, and audit our supply chain pay off in the customer’s laboratory or production suite. Many of our partners entered collaboration after failed runs or contamination scares with less regulated sources. Once they experience tight lot-to-lot reproducibility, full documentation, and rapid technical support, their loyalty follows. This cycle of reliability, technical transparency, and open dialogue has shaped our philosophy toward every product, N-Acetyl-L-Proline among them.

    Supporting Process Intensification and New Methodologies

    Trends in fine chemical manufacture and peptide synthesis demand ever-faster, more efficient methods. N-Acetyl-L-Proline responds well to emerging technologies like flow chemistry, high-throughput screening, and enzyme-assisted synthesis. Its aqueous solubility supports compatibility with both organic and hybrid solvent systems, facilitating seamless transfer between unit operations. We routinely see customers push batch sizes from grams to multi-kilograms using our material, without needing major re-optimization— a detail that echoes the importance of robust starting material.

    Recent advances in automated peptide synthesizers and robotic formulation lines place fresh demands on raw material consistency. We coordinate closely with OEMs and equipment engineers, confirming that NApro-1121 meets both physical and chemical requirements for automated dosing and dissolution. Any drift in particle size or trace impurity levels triggers rapid corrective action. The end result: chemistry teams focus on process innovation rather than compensating for off-spec raw materials.

    Regulatory Readiness and Global Distribution Considerations

    Increased demand for N-Acetyl-L-Proline within pharmaceutical, nutraceutical, and biomedical device sectors comes with heightened scrutiny from regulators worldwide. We keep up with evolving standards, supporting material compliance with US, European, and Asian guidelines. Our documentation packages, including TSE/BSE statements and allergen declarations, reflect the growing complexity faced by global R&D and production teams.

    Supply chain disruptions—seen during pandemic bottlenecks and recent shipping delays—have pushed us to strengthen buffer stocks and dual-source our most critical precursors. We have used our own warehousing and distribution channels for over fifteen years, reducing reliance on generic third-party logistics. Quality and shelf life of N-Acetyl-L-Proline remain intact from our loading docks to the customer’s storage facility, confirmed by periodic joint audits and external laboratory tests.

    Technical Support and Continuous Feedback

    Our commitment does not stop at the shipment of N-Acetyl-L-Proline. Customers benefit from direct lines of communication with our technical team, who bring real production and synthesis experience into every answer. New research, regulatory notifications, or process updates trigger prompt information sharing. We track batch performance and field feedback, closing the loop between raw material science and applied production.

    Chemists working with custom peptides or advanced APIs sometimes face unique challenges—unexpected chromatographic profiles, solubility glitches, or downstream color changes. Our support staff provides troubleshooting based on first-hand knowledge—not just textbook answers—so that each problem becomes a chance to improve our processes and documentation. This responsive, real-time exchange of technical insight sets our manufacturing operation apart, translating into higher success rates and reduced experimental downtime for users.

    Conclusion: A Building Block for Innovation

    N-Acetyl-L-Proline has emerged as a core component in projects where precision, quality, and reliability put results within reach. Years of manufacturing experience, constant technical validation, and a commitment to rigorous standards shape both the compound itself and the experience of those who rely on it. As scientific fields race ahead, this single detail—a consistently high-quality amino acid derivative—provides stability and opportunity in R&D, production, and beyond.