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Theophylline-7-Acetic Acid

    • Product Name Theophylline-7-Acetic Acid
    • Alias Theophylline-7-acetic acid
    • Einecs 212-489-5
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    732921

    Chemical Name Theophylline-7-Acetic Acid
    Molecular Formula C9H8N4O4
    Molecular Weight 236.19 g/mol
    Cas Number 6468-64-2
    Appearance White to off-white powder
    Melting Point >300°C (decomposes)
    Solubility In Water Slightly soluble
    Purity Typically ≥98%
    Storage Temperature 2-8°C
    Synonyms 1,3-Dimethylxanthine-7-acetic acid

    As an accredited Theophylline-7-Acetic Acid factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Theophylline-7-Acetic Acid, 5g: Sealed in a clear, labeled amber glass bottle with a white screw cap, tamper-evident seal.
    Shipping Theophylline-7-Acetic Acid is shipped in tightly sealed containers to ensure stability and prevent contamination. It is stored at controlled room temperature, away from light and moisture. Packaging complies with safety and regulatory standards, including proper hazard labeling. Shipping documentation includes handling precautions, chemical identification, and Material Safety Data Sheet (MSDS) information.
    Storage Theophylline-7-Acetic Acid should be stored in a tightly sealed container, away from moisture and direct sunlight, at room temperature (15–25°C). Keep in a well-ventilated, dry area, separate from incompatible substances such as strong oxidizing agents. Properly label the storage container and ensure it is kept out of reach of unauthorized personnel to prevent accidental exposure or misuse.
    Application of Theophylline-7-Acetic Acid

    Applications of Theophylline-7-Acetic Acid in Industrial Manufacturing

    Theophylline-7-Acetic Acid serves as a critical raw material across several specialized segments in the pharmaceutical and chemical industries. As a direct manufacturer, we focus on high-purity supply and process-compatibility tailored for each distinct downstream process. Below outlines the key industrial application sectors, noting compliance controls, dosing, process flow, and representative finished goods.

    1. API Synthesis for Bronchodilator Drug Intermediates

    Pharmaceutical manufacturers use this compound as a core starting material in the synthesis pathway of selective xanthine-derived bronchodilators. In multi-stage organic synthesis, it is introduced after the initial methylation step where strict impurity profiles must be maintained to comply with current GMP and global pharmacopeia monographs. Downstream formulation chemists control molar ratios based on batch scale, targeted purity, and final metabolite structure. Finished intermediates get further processed into tablet or injectable forms under validated pharmaceutical procedures.

    Industry compliance standards

    • ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients
    • European Pharmacopoeia 11th Edition—Monographs on Xanthine Derivatives
    • US FDA 21 CFR Parts 210/211 for Finished Pharmaceuticals
    • EDQM Certificate of Suitability (CEP) Protocols

    Typical usage ratio

    • 0.6–1.2 mol equivalent standardized to batch target
    • Adjusted by stoichiometry of downstream alkylation and hydrolysis steps

    Downstream process integration

    • Added post-initial methylated xanthine ring closure
    • Enters direct amidation or esterification pathway
    • Purity verified by HPLC and NMR prior to isolation of active intermediates

    Final product types

    • Theophylline anhydrous API for respiratory therapies
    • Modified-release bronchodilator tablets
    • Therapeutic injectable drug substances
    • Pharmaceutical granule premixes

    2. Diagnostic Reagent Raw Material for Clinical Test Kits

    In the production of enzyme immunoassay (EIA) and high-performance liquid chromatography (HPLC) reference materials, Theophylline-7-Acetic Acid is utilized as a calibrator or component in test kit formulation. Manufacturers require strict batch-to-batch consistency to meet analytical validation protocols. Chemical analysts formulate it into lyophilization mixtures where precise concentration and solvent compatibility determine diagnostic reliability.

    Industry compliance standards

    • ISO 13485:2016 for Medical Device Quality Management
    • CLSI EP25-A for Stability Evaluation of In Vitro Diagnostic Reagents
    • US Pharmacopeia General Chapter <1225> Validation of Compendial Procedures
    • FDA 21 CFR Part 820 for IVD Manufacturing

    Typical usage ratio

    • 0.005%–0.05% w/w in reference standard solutions
    • Optimized based on sensitivity requirements of immunoassay platforms

    Downstream process integration

    • Dosed into standard curve calibration mixtures
    • Lyophilized together with matrices for diagnostic reagent lots
    • Quality checked for trace-level degradation and contaminant exclusion

    Final product types

    • Serum/theophylline monitoring kits for clinical labs
    • Reference standards for therapeutic drug monitoring
    • HPLC calibrator blends for clinical chemistry analyzers
    • Enzyme immunoassay diagnostic test kits

    3. Precursor for Veterinary Pharmaceutical Formulations

    Animal health product manufacturers use this material as an active building block in the production of veterinary xanthine derivatives. It enters the formulation stage under documented SOPs to ensure species-specific pharmacokinetic and residue compliance. Veterinary pharmacists determine usage ratios by animal class and adjust based on dose-form conversion losses. Rigorous QC ensures no non-compliant residues for livestock medicines.

    Industry compliance standards

    • VICH GL3 (GMP) for Veterinary Medicinal Products
    • Ph. Eur. Monographs for Veterinary APIs
    • US Pharmacopeia—Monograph for Animal Drug Substances
    • China Veterinary Pharmacopoeia (CVP) API Entries

    Typical usage ratio

    • 0.8–1.0 mole equivalent per batch of veterinary precursor API
    • Adjusted for targeted animal species (canine, bovine, equine)

    Downstream process integration

    • Enters as a substrate in coupling reactions with amino alkyl reagents
    • Monitored by LC-MS to control impurity profiles before formulation
    • Mixed into premixes for veterinary tablets, powders, or injectables

    Final product types

    • Veterinary bronchodilator API premixes
    • Oral and injectable formulations for livestock treatment
    • Animal health feed additives (medicated)
    • Compounded equine medicine APIs

    4. Synthesis of Research Chemical Standards for Pharmaceutical R&D

    Analytical and medicinal chemistry labs utilize this material for constructing reference standards and in metabolite identification studies during preclinical drug discovery. R&D scientists value it for controlled purity and accurate structure elucidation. Usage ratios depend on trial scale and experimental endpoints. Quality control teams rely on traceability logs and full impurity profiling to meet regulatory dossier submission.

    Industry compliance standards

    • OECD GLP Principles for Non-Clinical Laboratory Studies
    • ISO/IEC 17025:2017 for Testing and Calibration Laboratories
    • FDA Guidance for Industry—Q2(R1) Analytical Procedures
    • EMA ICH M3(R2) Nonclinical Safety Studies Requirements

    Typical usage ratio

    • 1–100 mg per research batch (preclinical scale)
    • Scaling based on number of target analytes and study design

    Downstream process integration

    • Incorporated into reference panel synthesis or metabolite libraries
    • Prepared in analytical-grade solvents for LC-MS or NMR
    • NMR and HPLC validated for structure confirmation before study start

    Final product types

    • Metabolite standard reference samples
    • Calibration solutions for mass spectrometry
    • Internal standards for pharmacokinetic assays
    • Analytical R&D test kits
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    Certification & Compliance
    More Introduction

    Theophylline-7-Acetic Acid: Bridging Experience and Precision in Chemical Manufacturing

    Introducing Theophylline-7-Acetic Acid

    The manufacturing of Theophylline-7-Acetic Acid stands on the backbone of carefully refined processes and decades of first-hand industry experience. We have witnessed firsthand the shift in expectations from the pharmaceutical and chemical research sectors for consistent, high-purity intermediates such as this compound. Those who work with specialty xanthine derivatives understand the level of detail and commitment necessary for reproducible outcomes, and this knowledge has shaped every stage of our production of Theophylline-7-Acetic Acid.

    Our Production Approach and Commitment to Consistency

    Consistency doesn’t begin in the quality control lab; it takes root right at the first reaction. Every lot of Theophylline-7-Acetic Acid leaving our reactor arises from a habit of never cutting corners and an ethos of constant process review. Our staff handles all raw materials under protocols developed over years of trial and improvement. Purity profiles and traceability aren’t buzzwords here—each batch reflects thorough logged process steps and hands-on technical checks, carried out by operators and chemists who know both where impurities come from and how to head them off. Through these measures, we produce material that matches the strict analytical standards demanded by leading R&D groups and API manufacturers.

    Specifications Born from Industry Feedback

    The practical requirements for Theophylline-7-Acetic Acid have been shaped by repeated feedback from our customers. The product typically features assay values above 99% by HPLC, with controlled residue on ignition, moisture level below 0.5%, and minimal trace metals. These parameters reflect real-world research needs rather than arbitrary targets. Material appearance—from flow to color—has been adjusted based on conversations with process chemists who need ease of handling, filtration, and transfer. By investing effort in listening to user frustrations, we’ve arrived at a product where compliance with major pharmacopoeia reference standards is the natural outcome of process vigilance, not last-minute intervention.

    Understanding the Unique Role of Theophylline-7-Acetic Acid

    This compound bridges the gap between basic xanthine derivatives and more elaborate adenosine antagonists and bronchodilator scaffolds. We’ve shipped lots both to generic drug makers and discovery teams aiming to modify the core for improved selectivity or novel IP. In direct conversation with our technical support, researchers want to know about residual solvents, polymorph content, and storage guidance. Our experience comes through by providing not just routine COA paperwork, but context about which analytical tests are most relevant for different applications—whether that’s solid-state formulation, salt formation, or more fundamental structure-activity exploration.

    Contrast with Conventional Theophylline Derivatives

    Many users arrive familiar with Theophylline or related methylxanthines, and want to know how Theophylline-7-Acetic Acid differs. The core contrast arises from the appended acetic acid moiety on the seventh position, which fundamentally changes the physical and reactivity profile. Our scientists tracked how this affects solubility, salt formation, and the suitability as a handle for side-chain modification or conjugate synthesis. Standard theophylline gives predictable bronchodilation and CNS stimulation as an API, whereas Theophylline-7-Acetic Acid is valued for its dual chemical reactivity: maintaining the pharmacological backbone while allowing for attachment chemistry not available on parent theophylline.

    Process chemists have commented on the manageable melting point and non-hygroscopic nature compared to other acylated xanthines on the market. In our pilot campaigns we saw that crystallization from water or lower alcohols gives consistently robust batch yield, with minimal batch-to-batch scatter. That may look like a small detail, but for synthetic teams it means more predictable productivity and fewer troubleshooting headaches down the line.

    Performance in Application: First-Hand Observations

    Time in the manufacturing trenches teaches lessons not captured by spec sheets. For example, we’ve noticed how cold storage can arrest hydrolysis far more effectively than just relying on dryness. Our deliveries package the product in laminated, light-impermeable containers—an approach suggested by pharmaceutical partners who struggled with yellowing or decomposition when using single-layer plastics. There’s a certain peace of mind in knowing that the end-user receives material as pristine as it left our line, not altered by rough transit or a few days’ delay due to customs.

    Clients running scale-up reactions using Theophylline-7-Acetic Acid often ask about minimal pre-treatment. Drawing on bench testing and hundreds of scaled runs, our team is able to advise on solvent choice, pH window, and even agitation styles that work best with this compound. These insights grew from years of working side-by-side with development chemists who need answers that work on their timeline, not hypothetical best-case scenarios.

    Case Studies: Challenges Met with Real-World Solutions

    A respiratory drug manufacturer once shared with us how a competing supplier’s lot exhibited off-color and on-processing variabilities, risking entire downstream campaigns. After a root-cause review, we identified that overlooked process water history could cause subtle but significant changes in color and impurity profiles. We worked directly with the customer’s analytical group, running parallel analyses and process modifications, to nail down the optimum synthesis conditions. By implementing a series of additional in-process checks, shifting to high-purity input solvents, and modifying purification timelines to minimize side reactions, yields improved and off-color incidents vanished in subsequent lots.

    Another research group wanted to adapt Theophylline-7-Acetic Acid for a flow chemistry set-up using continuous dosing. Output was only as steady as the raw material’s flowability and dispersibility. Our process team provided technical sheets detailing particle size distribution and recommended pneumatic transfer rates. Through on-site troubleshooting, we fine-tuned our drying and sieving steps, delivering a lot that ran smoothly in the client’s automated system for several consecutive weeks—proof that collaboration between user and supplier leads to practical gains in scale-up.

    Supporting Innovation and Regulatory Confidence

    Long-term commitment to making specialized intermediates such as Theophylline-7-Acetic Acid has forced us to invest in both people and instrumentation. Our on-site QA team consists of analysts with years spent in regulated environments, leading to batch files and batch records comprehensible to those with their own regulatory burdens in mind. Each shipment includes full test reports, but more importantly, we retain back-lot samples and process data for restrospective review. Such steps mean that, during regulatory submissions or audits, our users can request documentation that closes any compliance gaps before they grow into batch rejections or costly recalls.

    The feedback loop between our analytical team and process chemists has kept our specification sheets focused on what customers actually need to see—be that trace-level residual solvent data, detailed impurity mapping by LC-MS, or evidence of low-endotoxin content for preclinical applications. This two-way communication minimizes wasted effort and builds a transparent chain of documentation from source to end-user.

    Challenges in Sourcing and Reliable Access

    We’ve all heard stories in the industry—projects delayed, development timelines ruptured—because a critical intermediate didn’t arrive in time, or showed unexpected analytical outliers. Many clients approach us after facing such troubles elsewhere. The reality is, raw material purity and documentation must stay on track through every logistics disruption, from customs holdups to regional shortages. By keeping primary processing and packaging under one roof and holding strategic safety stocks, we can buffer against supply shocks. This is particularly relevant for rare xanthine intermediates, which don’t benefit from the diversification enjoyed by legacy products and must be protected with added logistical attention.

    Don’t underestimate the value of raw, open communication with users reeling from unexpected delays elsewhere. On several occasions, a frank discussion about production status or shipping realities helped our customers make informed adjustments before problems snowballed. This cycle of transparency is worth more than any promise of guaranteed lead times, because flexibility grows from realism, not wishful thinking.

    Differences from Other Theophylline Derivatives

    Compared to plain Theophylline or its more common alkylated analogs, Theophylline-7-Acetic Acid carves out a niche as both a stable API intermediate and a versatile synthetic building block. The 7-acetic position provides a functional handle for further derivatization—whether for introducing amides, esters, or tailored conjugates. During in-house profiling, we noted improved handling versus N1/N3-acylated compounds, especially under neutral to slightly basic pH. This aspect translates into lower formation of unwanted byproducts and easier process clean-up, as charted across a wide array of pilot and full-scale runs.

    Its stability during storage—evidenced by accelerated shelf-life testing—gives it an advantage for users who need to build inventories for campaign work or staggered trials. Our HPLC and NMR surveillance, spanning real-time and accelerated conditions, confirms that it resists dimerization and decomposition to a far greater extent than various other xanthine acetates most users start out with during development. For teams planning late-stage modifications, such reliability avoids the last-minute panic of rerunning stability studies or negotiating extra stability data for regulatory filings.

    Real Value: Knowledge Passed Down in Manufacturing

    Chemical manufacturing isn’t a plug-and-play world. Often, the person running the reactor knows more about the quirks of a synthesis than can be captured in any formal SOP. Over years making Theophylline-7-Acetic Acid, tacit knowledge settles in: techniques for smooth filtration, tricks to coax the cleanest crystal crop, reading the subtle cues in color or smell that foreshadow a hiccup in process. These details add up to more than the sum of their parts—batch after batch, improvements compound. The result is not just an output that fits an assay spec, but a supply chain that end users trust with their time and their reputation.

    Customers often cite our willingness to share “the little things” that make a difference—right down to best practices in reconstitution or long-term sample handling. Offering this kind of targeted, experience-based advice remains a critical part of our approach, because no two end users operate at the same scale or with the same equipment. Suggestions like pre-warming solvents or gentle agitation aren’t found in textbooks, but those who synthesize or formulate daily know their impact.

    Safety, Handling, and Compliance: Putting Experience to Work

    Our safety recommendations reflect more than regulatory compliance—they reflect hundreds of combined years at the bench. Theophylline-7-Acetic Acid doesn’t pose the same exposure concerns as certain other xanthines, but over time we’ve worked out handling protocols that prevent material stress and maximize robustness for repeated use. Physical forms are chosen based on minimizing dust and maximizing operator comfort, and our packaging lines account for the full realities of warehouse and lab environments, not theoretical storage spaces. We craft our safety data—and container labeling—based on where the actual risks lie, simplifying life for quality officers who must pass audits and reduce the possibility of workplace incidents.

    Supply chains now face more scrutiny than ever from regulators and customers alike. Every lot we produce includes a traceable record from receipt of raw input to final packaging. This end-to-end documentation lets clients facing due diligence or regulatory review come to us for data, secure in the knowledge that we prioritize transparency and accountability over mere box-checking.

    Continuous Improvement Driven by User Experience

    As a manufacturer, sticking to what works is tempting, but customers push us to challenge our own assumptions. Each feedback session pushes us to fine-tune analytical methods, revisit timelines, or explore greener process alternatives. For instance, teams developing green chemistry routes have queried solvent and reagent choices, leading us to pilot alternative recrystallization and isolation techniques that minimize process waste. In these trials, sharing real-time observations with users often surfaces new watch-points or improvement opportunities we hadn’t anticipated.

    Over the years, our process for Theophylline-7-Acetic Acid has grown more robust and sustainable. We now routinely capture and recycle process solvents, optimize for minimal energy input on drying, and use precision analytical instruments to reduce sample waste. These small incremental changes translate into a product that supports both performance and sustainability goals—practical gains that arise from technical exchange and a shared commitment to better chemistry.

    Closing Reflections: The Meaning of Reliability in Chemical Manufacturing

    Every day, the true test of a specialty chemical like Theophylline-7-Acetic Acid comes from the users who call or write when timelines are tight and outcomes are critical. As a manufacturer, we have watched how real progress—whether a successful process transfer, a smooth regulatory audit, or a breakthrough in research—comes down to more than just an accurate spec sheet. It arises from a culture of shared experience, accumulated knowledge, and unflagging communication. Each lot we supply contains not only our expertise, but the input and real stories of those who work with us.

    Through years of partnership with R&D groups, API teams, and formulation innovators, we’ve learned that success in chemical manufacturing is built upon foundations of trust, experience, and relentless improvement. That is what defines Theophylline-7-Acetic Acid as more than just another product on a list. It’s the outcome of care, of technical rigor, and of a constant conversation with the people who shape tomorrow’s breakthroughs.