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Phenelzine

    • Product Name Phenelzine
    • Alias Nardil
    • Einecs 200-331-8
    • 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
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    Specifications

    HS Code

    505100

    Generic Name Phenelzine
    Brand Name Nardil
    Drug Class Monoamine oxidase inhibitor (MAOI)
    Route Of Administration Oral
    Indication Major depressive disorder
    Mechanism Of Action Inhibits monoamine oxidase, increasing serotonin, norepinephrine, and dopamine
    Dosage Form Tablet
    Prescription Status Prescription only
    Common Side Effects Dizziness, dry mouth, weight gain, insomnia
    Contraindications Pheochromocytoma, severe liver disease, use with certain medications
    Half Life 11.6 hours
    Metabolism Hepatic

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

    Packing & Storage
    Packing Phenelzine is packaged in amber glass bottles containing 100 tablets, with a secure child-resistant cap and clear dosage labeling.
    Shipping Phenelzine is shipped as a hazardous chemical, typically under regulated conditions to ensure safety. It must be securely packaged, labeled with appropriate hazard warnings, and accompanied by shipping documentation. Temperature and moisture controls may be required, and only authorized carriers and handlers familiar with chemical transport regulations should manage its shipment.
    Storage Phenelzine should be stored in a tightly closed container at controlled room temperature, ideally between 20°C to 25°C (68°F to 77°F). Keep it away from moisture, heat, and direct light. Store in a secure area away from incompatible substances and out of reach of children and unauthorized persons. Ensure proper ventilation and follow all regulatory guidelines for storing hazardous chemicals.
    Application of Phenelzine

    Applications of Phenelzine in Industrial Manufacturing

    Phenelzine serves critical roles in specific industrial manufacturing sectors, where its chemical reactivity and pharmacological attributes support essential downstream production processes. The following sections detail practical applications, focusing on sectors with stringent regulatory oversight, defined formulation parameters, traceable use in industrial workflows, and clear finished product destinations.

    1. Active Pharmaceutical Ingredient Synthesis (Psychiatric Medications)

    Manufacturers of central nervous system pharmaceuticals incorporate phenelzine as a primary active substance in the synthesis of monoamine oxidase inhibitor (MAOI) drugs prescribed for complex depressive disorders. The compound’s sensitive handling profile aligns with cGMP protocol during formulation, and its traceability is key for regulatory submissions. Processing includes multi-stage solvent extractions, recrystallization, and stringent purification, culminating in APIs that downstream formulators convert to oral dosage forms. In this scenario, maintaining full material traceability and compositional accuracy enables compliance throughout global market supply chains.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients
    • United States Pharmacopeia (USP) Monograph requirements
    • European Pharmacopoeia (Ph. Eur.) standards
    • China Pharmacopoeia (ChP) API test parameters

    Typical usage ratio

    • API synthesis utilizes phenelzine as the principal constituent, representing 90–99% of final purified API mass per batch; formulation ratios are tightly controlled, and adjustments are based on targeted impurity profiles and batch yield optimization.

    Downstream process integration

    • The material enters during initial condensation and reaction steps as the amine reactant; integration includes subsequent pH adjustment, multi-solvent purification, and chromatographic separation for API isolation.

    Final product types

    • Pharmaceutical-grade phenelzine sulfate tablets
    • Bulk API powders supplied for formulation
    • Capsule and controlled-release psychiatric dosage forms

    2. Reference Standard Manufacturing for Analytical Laboratories

    Producers of certified analytical reference materials incorporate phenelzine to meet the demand for calibration standards used in pharmacokinetic, forensic, and clinical testing laboratories. Material qualification requires ultra-high purity and identity testing according to global regulatory frameworks. Downstream production emphasizes high-purity recrystallization, batch-specific impurity profiling, and standardized packaging, ensuring accurate and reproducible results for customers engaged in quantitative method validation, stability studies, and cross-lab calibration.

    Industry compliance standards

    • ISO 17034 General Requirements for the Competence of Reference Material Producers
    • ISO/IEC 17025 Testing and Calibration Laboratories Standards
    • FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

    Typical usage ratio

    • Producer isolates phenelzine to >99.9% purity; each certified reference material sample typically contains 1–5 mg aliquots in sealed vials calibrated against certified mass values, with no matrix dilution.

    Downstream process integration

    • Material enters post-synthesis as crude phenelzine; subsequent use involves final fine purification, homogeneity assessment, batch certification, precise aliquoting, and contamination risk management prior to packaging.

    Final product types

    • Certified reference standards for HPLC/GC-MS analysis
    • Proficiency testing samples used in regulatory and research laboratories
    • Commercial analytical kits for laboratory quality control

    3. Clinical Toxicology and Forensic Reagent Formulations

    Manufacturers specializing in diagnostic reagents and forensic test solutions incorporate phenelzine in standard panels required for qualitative and quantitative toxicology screening. The substance’s specific detection enables forensic laboratories to identify MAOI exposure in biological matrices, necessitating strict sourcing, validated formulation techniques, and traceable blending processes. Production takes place under laboratory-grade QC, with the material added after prefiltration and prior to reagent stabilization in single-use or multi-use kits.

    Industry compliance standards

    • ISO 13485 Quality Management System for Medical Devices
    • CLSI C62-A Laboratory Quality Standards
    • FDA 21 CFR Part 820: Quality System Regulation

    Typical usage ratio

    • Reagent kit formulations use phenelzine at analytical detection range—typically 0.1–10 µg/mL depending on the method and concentration required for calibration standards and control vials.

    Downstream process integration

    • After initial solubilization and filtration, phenelzine is dosed directly into test kit reagents and calibrators; lyophilization or stabilizer addition follows, securing batch consistency and shelf stability.

    Final product types

    • Forensic urine/plasma analysis kits
    • Certified diagnostic reagent panels
    • Clinical laboratory standards for substance identification

    4. Pharmacological Research Chemical Supply

    Producers of research-grade chemicals supply phenelzine to universities, CROs, and preclinical research facilities for experimental pharmacology, neurological studies, and mechanism-of-action investigation. Supply chains require accurate batch documentation, low-residual solvent levels, and packaging designed to prevent cross-contamination or degradation during storage. Downstream users incorporate phenelzine in cell-based assays and in vivo models, and manufacturers ensure standardized form and sampling protocols.

    Industry compliance standards

    • OECD Principles of Good Laboratory Practice (GLP)
    • REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) for laboratory chemicals
    • US National Institutes of Health (NIH) Guidelines for Research Chemicals

    Typical usage ratio

    • Material is supplied in concentrations from 1 mg/mL to 100 mg/mL solution or as solid for researcher-prepared dilutions; exact working concentration per end-user experimental protocol.

    Downstream process integration

    • Packaged after validated batch quality control and purity assessment; integration occurs when research staff weigh, dissolve, or aliquot phenelzine for dosing in experimental setups.

    Final product types

    • Research-use-only chemical inventory bottles
    • Pre-weighed reference tubes for experimentation
    • Pharmacological screening libraries
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    Certification & Compliance
    More Introduction

    Understanding Phenelzine: A Manufacturer’s Perspective

    What Sets Our Phenelzine Apart

    Every chemical facility sees trends come and go, but a compound like phenelzine stands apart for its precise impact and the skill required to manufacture it. As the ones who build phenelzine from the ground up, we keep control over every part of its journey—right from sourcing raw hydrazine to the final sealed drum. In a market where synthetic precision matters, hands-on quality checks and batch traceability define the product, not slogans or numbers on a spec sheet.

    Many people know phenelzine from pharmaceutical texts. The reality on our production floor is much more rigorous. Phenelzine’s chemical structure—N2H5C6H5—may look straightforward, but turning it out at scale, batch after batch, calls for expertise with hydrazines and careful temperature management. This work is not like mixing dyes or simple catalysts. Careful attention keeps impurities at bay and ensures purity that meets regulatory expectations, especially because trace contaminants change how the compound behaves in real-world use.

    Key Features and Specifications

    Most industries work with phenelzine in its hydrochloride salt form, presenting as white to off-white crystalline powder. Purity matters a great deal; we typically deliver phenelzine hydrochloride at no less than 99.5% assay, confirmed by HPLC and NMR as part of our standard batch release protocol. In practice, the melting point comes tightly pinned within 149–153°C—a detail our QC team checks for every lot. Residual solvents fall below regulatory limits, as set by pharmacopeial monographs, because technicians pull chromatograms from raw solution, not only the finished drum.

    Putting Phenelzine to Work

    Most of the phenelzine leaving our facility steps into the pharmaceutical world. It acts as an active pharmaceutical ingredient, especially as an antidepressant in the monoamine oxidase inhibitor (MAOI) category. Safety and reliability here rely on consistency between each shipment. Each kilogram must match both internal in-process controls and formal compendial standards; we have staff dedicate significant time to protocol reviews before greenlighting an order for release. It’s easy to talk purity numbers; what counts is actually keeping those impurities—particularly hydrazine and heavy metals—out of the final blend. This demands handling raw materials that have themselves passed strict incoming analysis.

    Over the years, research labs and commercial producers have used phenelzine as a synthetic intermediate beyond its classic pharmaceutical applications. Academic teams request it for the preparation of structurally complex hydrazones and for studies in neurochemistry. Applying phenelzine in these varied domains has sharpened our expertise in producing material not only for GMP drug manufacture but also for R&D purposes. Many requests center around particle size distribution, solubility profiles, and storage stability. Researchers expect material that works the same way every time; small deviations in processing methods can alter reactivity, so we seldom alter temperature profiles or solvent systems between lots.

    Manufacturing Integrity and Regularity

    In this business, producing phenelzine isn’t just a checkbox to tick; it represents a convergence of engineering and chemical control. The production floor blends real-world constraints—cost, safety, regulatory pressure—into every step. Unlike traders or distributors, our staff calibrate reactors, monitor thermal profiles, and actually observe changes in reaction mixture color or composition. It’s the difference between managing a living process and simply moving goods on paper.

    Many customers compare phenelzine from various sources. What often goes unmentioned is that even minor changes in synthesis route or crystallization setup can yield batches with variable shelf life or solubility. Our approach fixes parameter windows closely and cross-verifies results using reference samples from prior years. This approach didn’t come overnight; it evolved through process tweaks rooted in numbers and firsthand observations on aging, caking, and storage.

    The Importance of Traceability and Transparency

    Every finished drum of phenelzine hydrochloride exits our warehouse with analytical records that match back to production logs. Our staff fill these records themselves, not contractors. This isn’t paper-shuffling; it gives end users proof that the compound came through a verifiable chain under watchful eyes, not a mystery origin. Our role blends traditional manufacturing discipline—careful batching, reactor control, lot documentation—with data-driven traceability, connecting each coherent step from raw chemical to the final, labeled drum.

    No importer or broker can match this level of traceability because they rely on upstream vendors and disconnected audit chains. That distance introduces the risk of dilution, substitution, and mislabeling. We’ve seen samples on the market with delayed stability failure, inconsistent color development, or odd melting behavior—usually flagging upstream adulteration or careless blending. By manufacturing phenelzine directly, we shield our customers from these issues.

    Meeting Evolving Regulatory Expectations

    Every year, expectations climb for documentation and safety. Our quality management team keeps up with changes from major agencies—FDA, EMA, and their peers in Asia. This requires adaptive internal procedures and an archive of historic data. When rules shift or impurity limits tighten, we run comparison analyses and adapt controls, not only for the latest shipments but also for warehouse inventory that’s already packed. Pharmaceutical partners require assurance that their active component remains in bounds, whether their own regulators shift policies or international harmonization projects raise the bar.

    We maintain validated cleaning, weighing, and filling protocols—audited by both onsite and external inspectors—so every run meets both internal rigor and outside expectations. Each production supervisor takes direct responsibility for compliance and long-term quality, since a problem batch stains reputations fast. We know by heart the standard for hydrazine residual content—typically below 10 ppm—and align our analytic tools to spot deviations before they leave our gates. This type of operational rigor goes beyond passive oversight.

    Differences vs. Other Products and Producers

    Phenelzine differs from more generic reagents in a few significant ways. Synthetically, its process shares roots with hydrazine-based pharmaceuticals, but the risk and purity demands push the work into a higher category. Staff cannot treat these production runs like simple solvents or excipients; instead, controls go beyond basic filtration and crystallization. Unlike broad-use chemicals that tolerate batch-to-batch variation, specialty drugs like phenelzine reveal every minor deviation in patient or research outcomes.

    Many commodities invite contract manufacturing or dilution, but phenelzine does not tolerate shortcuts. Attempts to maximize output by tweaking reaction times or cutting crystallization steps usually backfire—either in higher impurity levels or brittle crystals that spoil before the expiration date. We’ve rebuilt entire lines when even seemingly minor reprocessing steps led to instability. Unlike traders, we don’t have the luxury of offloading misfit batches into generic markets. The work and cost of discarding any questionable product far outweighs the risks to our credibility. Our process design reflects this reality.

    Supporting Innovation with Supply Stability

    Research and development teams reward stability. With phenelzine, it’s easy to promise high assay and low metals on a certificate, but harder to guarantee that performance sticks year after year. Many research groups rely on our supply during clinical studies spanning several years. Losing batch-to-batch consistency eats time and money during regulatory submissions and stability trials. We back this consistency with batch archive samples so that if a problem arises, we can test back across the whole production history—not only paperwork but stored sub-samples of raw and finished goods.

    Over the past decade, we’ve built redundancy into our process—multiple crystallization vessels, backup filtering units, and isolated storage. Interruptions could force researchers to revalidate projects or pause clinical programs, costing far more than any nominal savings offered by a broker. Having seen firsthand the cost of supply hiccups, we make production scheduling and preventive maintenance a permanent discussion in daily operations.

    Practical Handling and Safe Use Guidance

    Phenelzine’s chemistry rewards meticulous storage and handling. Moisture and light trigger creeping degradation; casual exposure creates instability that can undo months of planned research or drug production. Our drums and packaging reflect these risks. We use moisture barriers and inert atmosphere pads, not only for customs paperwork but to ensure material integrity after shipment and during long-term storage. We insist on handling procedures that respect these sensitivities because the product’s behavior shifts rapidly outside of defined parameters.

    Every user, from pharmaceutical plant to research lab, deserves clear guidance. Our technical team provides firsthand advice, based on results from real-world use studies, not merely literature review. For example, rapid weighing in non-humid rooms, quick sealing, and avoidance of direct sunlight prevents yellowing and loss of potency. End users value these small but critical details since, in every batch complaint we’ve traced, corners were cut in those first few minutes after the drum’s seal broke.

    Commitment to Process Improvement and Customer Feedback

    Producing good phenelzine means learning from each run. Over the years, we’ve incorporated feedback—particle flow, packaging upgrades, reactivity request—from every client and in-house operator. We invest in equipment upgrades and process tweaks based on experience, not on a whim or for marketing appeal. No third party or distributor can replicate the insight gained from years on the ground watching what works and what fails.

    Customer feedback shapes the way we develop material specifications: one year might bring requests for tighter sieve fractions, another for extended real-time stability. We see these as opportunities to refine—not dilute—our core process. It’s common to test out new filters, packing resins, or antistatic linings after hearing from clients whose handling environments differ from our own. Practically, this reinforces a feedback loop: we hand insights to customers, and in return, our product adapts in meaningful, measurable increments.

    Supporting Analytical Confidence

    Every analytical result supporting our phenelzine is linked to a chain of calibrated standards, reviewed by in-house chemists with years behind the bench. Routine HPLC profiles, melting point checks, and heavy metals screens confirm every batch’s fitness before it leaves the plant. We back numbers with retained samples and dual-lab cross-validation. This chain of custody, and the knowledge embedded in our staff, gives users more than just a data sheet; it provides assurance against unseen variability or accidental cross-contamination.

    Customers who move to our phenelzine after working with third-party brokers usually remark on the difference: lower baseline impurity profiles, more stable powders, and cleaner, more predictable analytical traces. This gives them confidence as they move into regulatory filing, validation, or publication. Analytical reliability roots itself in direct control, not the hope that an upstream partner did the job right.

    Responding to Supply Chain Challenges

    Global events, changing regulations, and increased demand all play into challenges with chemical supply. Operating as an actual manufacturer gives us the ability to reshape schedules, prioritize critical batches, or respond quickly to corrections. During periods of regulatory review or importation delays, we can adjust output and delivery timelines with flexibility. This holds strong appeal for commercial and R&D customers who cannot wait through months of backordered intermediates or last-minute substitutions.

    We hold backup stocks of both starting materials and finished phenelzine, rotate inventory, and keep a close eye on expiration profiles. Our facility invests in timely requalification and protocol updates. Third-party brokers often oversell supply guarantees without owning the risk of delayed or questionable deliveries. Hands-on manufacturing absorbs this risk and moves to solve the bottleneck instead of passing blame.

    Conclusion: Delivering Value Through Experience

    Our perspective as a producer reaches well beyond matching an assay value or ticking off a regulatory box. Each step, from the initial hydrazine blend to the final release, leaves an imprint on quality and confidence. Phenelzine grew from a specialized, challenging compound into an ingredient whose reliability underpins pharmaceutical and research success. Over years in this field, controlled production, strong documentation, and a continual drive for improvement have delivered material end users trust—not simply because the label says so, but because every batch reflects a long chain of craft, care, and experience.