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Selegiline Hydrochloride

    • Product Name Selegiline Hydrochloride
    • Alias Deprenyl
    • Einecs 244-897-4
    • 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

    829631

    Generic Name Selegiline Hydrochloride
    Brand Names Eldepryl, Zelapar, Emsam
    Chemical Formula C13H17N·HCl
    Drug Class Monoamine oxidase B (MAO-B) inhibitor
    Route Of Administration Oral, transdermal
    Indications Parkinson's disease, major depressive disorder
    Mechanism Of Action Inhibits MAO-B enzyme, increasing dopamine levels
    Appearance White crystalline powder
    Storage Conditions Store at 20°C to 25°C (68°F to 77°F), protect from moisture
    Cas Number 14611-51-9

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

    Packing & Storage
    Packing Selegiline Hydrochloride, 25g, packaged in a sealed amber glass bottle with a tamper-evident cap and detailed labeling for safety.
    Shipping Selegiline Hydrochloride is shipped in tightly sealed containers, protected from light and moisture. It is classified as a pharmaceutical ingredient and may be subject to regulatory restrictions. Typically transported at room temperature, shipping documentation includes handling instructions and safety data. Compliance with all local and international chemical transport regulations is ensured.
    Storage Selegiline Hydrochloride should be stored in a tightly closed container at room temperature, typically between 20°C and 25°C (68°F and 77°F). Keep it away from light, moisture, and incompatible substances. Store in a well-ventilated area, and protect from excessive heat. Ensure that it is kept out of reach of children and unauthorized personnel.
    Application of Selegiline Hydrochloride

    Applications of Selegiline Hydrochloride in Industrial Manufacturing

    As an experienced chemical raw material manufacturer, we supply Selegiline Hydrochloride for advanced pharmaceutical and fine chemical production. Below are the most established downstream industrial application scenarios, highlighting sector-specific compliance, typical formulation ratios, integration into production, and resultant end-products.

    1. Active Pharmaceutical Ingredient (API) for Anti-Parkinson Formulations

    Global producers use Selegiline Hydrochloride as a primary active ingredient in anti-Parkinson medications, especially in monoamine oxidase B (MAO-B) inhibitor therapies. Manufacturers adhere to region-specific GMP requirements and fine-tune batch formulations to yield predictable pharmacological activity and purity. The API typically enters wet granulation or direct compression stages in solid oral dosage forms, where tight assay controls guarantee therapeutic consistency. Downstream, pharmaceutical companies formulate tablets and capsules designed for precise patient dosing, following regulatory pharmacopoeias for assay and impurities.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice for APIs
    • European Pharmacopoeia (EP) 11.0 Monograph 01/2014:0271
    • United States Pharmacopeia (USP) Monograph
    • WHO GMP for Pharmaceutical Production

    Typical usage ratio

    • 0.5–11.25 mg API per tablet/capsule, finalized based on labeled dosage strength
    • Content uniformity targets set at 95–105% of stated dose
    • Excipient ratios adjusted to API load; Selegiline HCl represents 0.05–2.5% total tablet mass

    Downstream process integration

    • Added at initial blending stage for oral solid dosage forms
    • Subjected to blending, wet/dry granulation or direct compression
    • Inclusion in dissolution profile and batch yield QC
    • Integrated with tablet film-coating operations

    Final product types

    • Anti-Parkinson film-coated tablets
    • Oral capsules
    • Dispersible tablets
    • Buccal or sublingual tablets

    2. Reference Substance Supply for Pharmaceutical Quality Control Laboratories

    Pharmaceutical laboratories and contract research organizations require highly pure Selegiline Hydrochloride reference standards for analytical method validation, system suitability, stability studies, and dissolution profiling. These reference materials must meet or exceed the quality set by leading pharmacopoeias. Routine quality control assays in downstream production validate identity and content of the drug substance, especially in finished dosage forms.

    Industry compliance standards

    • European Pharmacopoeia (EP) Reference Standard Policies
    • USP Reference Standard Guidelines
    • ISO/IEC 17025 Laboratory Accreditation

    Typical usage ratio

    • 1–10 mg per analytical run, dependent on method sensitivity (HPLC, GC, TLC)
    • Reference stock prepared from certified purity batches

    Downstream process integration

    • Used in method calibration and batch release testing
    • Supports cleaning validation studies for shared production lines
    • Applied in stability indicating method validation

    Final product types

    • Certified secondary standards
    • Analytical reference solutions
    • Calibration kits for HPLC/GC
    • Stability study controls for regulatory filings

    3. Fine Chemical Intermediate for CNS-Active Molecule Synthesis

    Specialty intermediates manufacturers and contract synthesis providers utilize Selegiline Hydrochloride in the production of advanced CNS-active small molecules. It enters as a chiral building block or as a protected amine intermediate for further alkylation, reduction, or salt formation. The integration point depends on the target compound and desired enantiopure output, with process engineers controlling molar input and reaction conditions to minimize by-products and maximize yield.

    Industry compliance standards

    • REACH registration for intermediate chemicals (EU)
    • 21 CFR Part 210/211 Process Controls (for pharmaceutical intermediates)
    • Responsible Care Management System

    Typical usage ratio

    • As limiting reagent: 0.8–1.2 molar equivalents, proportioned to downstream synthetic route
    • Chemical consumption adjusted per batch size and impurity profile targets

    Downstream process integration

    • Introduced during reductive amination or alkylation
    • Subjected to phase transfer catalysis or salt metathesis, as required
    • Isolated and purified for further derivatization or coupling

    Final product types

    • Precursor intermediates for CNS pharmaceuticals
    • Modified propargylamines and derivatives
    • Process-optimized small molecule libraries
    • Advanced research compounds for neurological studies

    4. API for Veterinary Neurology Pharmaceutical Production

    Specialist veterinary pharmaceutical producers formulate Selegiline-containing medications targeting cognitive dysfunction and pituitary-dependent hyperadrenocorticism in companion animals, primarily elderly dogs. Production must use API-sourcing that meets veterinary pharmacopoeial standards and dovetail into oral liquid or solid formulation lines. Production teams maintain strict identity and potency controls, formulating end-dosage forms for veterinary clinical use according to established safety and stability parameters.

    Industry compliance standards

    • VICH GL9 Good Manufacturing Practice for APIs used in Veterinary Drugs
    • United States Pharmacopeia–Veterinary (USP–Vet) Monograph
    • European Pharmacopoeia 10th Ed. Veterinary Appendix

    Typical usage ratio

    • Dose: 0.5–2 mg/kg per animal, per dosage unit formulation
    • API constitutes approximately 0.1–1% of liquid or solid formulation mass
    • Formulation adjusted for animal body weight and intake route

    Downstream process integration

    • Incorporated during initial blend of active and excipients (powder, suspension, or solution forms)
    • Integrated with flavorants and stabilizers to ensure palatability and shelf stability
    • Batch-to-batch quality checked for veterinary compliance

    Final product types

    • Veterinary oral tablets
    • Oral suspension solutions for animals
    • Compounded veterinary medication sachets
    • Multidose oral formulations
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    Certification & Compliance
    More Introduction

    Selegiline Hydrochloride: Practical Insights from Our Factory Floor

    Daily Production Experience Shapes Our Selegiline Hydrochloride

    In chemical manufacturing, the path from raw material to finished Selegiline Hydrochloride is neither short nor simple. Years back, few in my team had even heard of this API. Today, our production line handles it as a staple, not only because it serves an essential purpose in pharmaceutical science, but because customers have come to count on our precise handling every week. The heart of our production rests in accuracy — not just in reaction temperatures or pH, but in knowing what happens if your solvents are out by a fraction, or temperatures aren’t matched batch to batch. Retailers and traders do not see how easy it is to end up with minute impurities if the line doesn’t stay clean, or if dehydration lags at a critical hour. Our approach doesn’t focus on fancy gadgets or gimmicks. We value practical process discipline, and decades of real failures and corrections have taught us where the problems settle.

    Specs Our Clients Actually Ask For

    Nobody calls us asking about ambiguous “high-purity API.” They ask straight, “What’s the assay on this lot?” or “How do your levels compare to what clinical buyers need?” Standard batches of our Selegiline Hydrochloride reach assay levels that meet or exceed pharmaceutical requirements — that’s a result of starting with high-quality raw amines and processing under strict controls. What matters most down the line: careful elimination of solvents, stabilized pH before crystallization, and always verifying that each batch holds up under both HPLC and UV analysis. The model shipped from our facility is typically Selegiline Hydrochloride with purity greater than 99%. Each gram comes as a white to off-white crystalline powder, with a melting point between 143°C and 146°C. Moisture content, a real bugbear in the rainy season, always stays under 0.5%, thanks to our post-filtration vacuum treatment. Pack sizes vary according to need, but for most commercial and research partners, we supply in heat-sealed aluminum foil pouches protected inside rigid containers, away from light and water.

    How It’s Actually Used—And Why Handling Matters

    We struggled, in our earlier years, to understand what actually happens to Selegiline Hydrochloride after it leaves us. Some think of it only as a Parkinson’s or depression medication ingredient. In practice, much of our material heads toward global markets for formulation into oral and transdermal drug products. Research teams in academic labs have come back to us more than once, flagging trace impurities that complicate their studies. A molecule like this doesn’t just need to be “pure.” It needs consistent particle size for compounding, and a stable crystalline form that resists ambient moisture — because pharmaceutical blending can get tricky if any chunking or caking slips through. A customer in humid Mumbai faced clumping in their blending tanks until we tweaked our final desiccation step. These are simple, everyday manufacturing headaches, but addressing them at the source solves expensive clean-up later.

    What Distinguishes Our Grade from Other Suppliers

    Comparing Selegiline Hydrochloride isn’t only about who advertises “US or EP” compliance. Our factory keeps track of feedback from repeat pharma partners. Often, clients switching over from generic bulk products notice clearer batch reproducibility— every bottle, drum, or sack matches up within a tight margin for both assay and impurities. Some mass-producers focus mainly on output; we choose to narrow our lines, maintaining smaller batch sizes and tighter controls. A colleague once joked about working in a “control freak” environment, but careful documentation keeps mistakes out of the pipeline. It also means our regular partner labs can skip lengthy additional re-purifications. Physical consistency stands out too — our Selegiline Hydrochloride flows well, saves headaches during blending, and shows no sign of chalking even after weeks on the warehouse shelf. This kind of feedback doesn’t show up on glossy product flyers, but it does build relationships over time.

    Results from Regular Testing: What Actually Goes Wrong in the Plant

    Quality assurance has become a cliche in chemical manufacturing, but on our side of the fence, QC is less about slogans and more about finding problems before they get out the door. We used to run HPLC purity checks only as a final sign-off, but a decade ago, we learned to pull random spots from in-process streams. If intermediate product looks suspicious — a hint less brightness, trace layer separation — we halt early. Simple color checking under the right lighting can catch mistakes in filtration, signal metal traces, or highlight a contamination that could cost a customer weeks in stability failures. Colleagues in QC spend real shifts checking for more than expected: microbial count, residual solvents per ICH guidelines, and identity verifications by FTIR and NMR. We keep reference spectra on file so any deviation—not just the numbers, but pattern recognition from years of handling the spectrum—brings us back in for corrections. Reporting these results is more than compliance — it’s survival in a field where one wrong batch can ruin a client’s confidence for good.

    Pitfalls from Large-Scale and Small-Scale Production

    Labs working with gram-scale production rarely run into the same pitfalls affecting kilo-lots. Running a 10 kg batch through our reactors means monitoring temperature profiles at every section, rechecking atmospheric exposure, and never assuming a “one size fits all” for filtration rates. If you scale up without adjusting for heat transfer or solvent evaporation rates, you end up with hot spots or crystallization that runs too quickly—leaving sub-par yield or off-spec color. Our scale-up process values slow, methodical changes, so the product on the back-end matches the pilot batches developed during research. On small scales, Selegiline Hydrochloride often takes the form of analytical reference material or clinical research active, where the batch size barely covers a petri dish’s worth. Mechanical losses and static cling sometimes eat up half a gram before you even run your test. We’ve learned not to downplay simple tools — antistatic wands, tight-sealing micro containers, and cautious handwork. It’s the detail work, honed through repetition, that keeps quality up no matter the lot size.

    Supplier Reliability from a Manufacturer’s Perspective

    Years of shipping Selegiline Hydrochloride to partners across Asia, Europe, and North America have shown us the real meaning of reliability. It doesn’t come from paperwork or impressive site-maps, but from proven records: orders landing on time through summer monsoons, packaging intact, clarity and simplicity in batch records, and complete regulatory documentation that checks out under review. Competitors sometimes sell on price. We often hear from returning buyers frustrated by crystallization in transit, or labeling errors that throw regulatory reviews off by a month. By sticking to heat-sealed packaging and batch-matched documents, we’ve reduced customer complaints close to zero. It’s less glamorous work: checking seals at 9pm in the shipping hall, reprinting certificates if even a date typo creeps in. The aim is transparency—clear GMP documentation and traceable chain of custody—so no regulator is ever left puzzled if a bottle’s cap color looks odd or a label smudges in transit.

    Learning From Customer Feedback and On-Site Audits

    Once, a critical client requested an in-depth process audit. Their team showed up with clipboards, but wanted to know more than our SOPs. They asked about crude filtrate disposal, humidity in the air at our drying room, and how we handled a slow-moving batch after an equipment breakdown. Their visit reshaped how we present our process. We introduced data loggers tracking temp and humidity 24/7. We now photograph random finished lots during packing for reference. Real stories from clients—those who need reassurance about what’s truly in each bottle—help us correct assumptions and make changes grounded in use, not just theory. Feedback comes from unexpected places too. A buyer in Germany dropped a line about finding tiny particulate matter in one lot during compounding. We sent our QC team back to the filtration station, traced the issue, and upgraded mesh screens to finer grades. Since then, particle contamination complaints have dropped off. Our repeat business proves that listening, not lecturing, gives better results.

    Sustainability in Selegiline Hydrochloride Manufacturing

    Production routines must keep up with both growing demand and tighter environmental controls. We’ve invested in closed-system reactors, improved our neutralization of waste, and made a point to reduce solvent emissions year by year. Not because it wins us headlines but because regulators visit unannounced, and local communities watch for odors from vent stacks, especially in village peripheries where our factory operates. Neighbors matter. We collect spent solvents for certified recycling, separating at source, and never rushing hazardous waste out the gate. Water use matters too. We circulate process water through cooling systems, capture for secondary use, and run strict checks before it leaves the facility. Only by seeing firsthand how small leaks or overflows affect the next plot of farmland do we catch problems early. That’s real “sustainability” — not a slogan, but a learned routine of responsibility, day after day.

    Problem Solving: A Real Manufacturer’s Approach

    Every year brings new challenges: supply chain crunches, weather disruptions, shifts in global regulatory requirements. Our warehouse staff tracks inventory not just by number, but by date of incoming and outgoing lots, especially with thermal-sensitive products like Selegiline Hydrochloride. Sudden spikes in humidity can throw off drying times. If a shipping lane faces delays, we redirect through alternative routes, pre-sealing materials in double wrappings. Sometimes, last-minute changes from clients—such as a switch to glass packaging for ultra-sensitive deliveries—cause headaches on the floor. We don’t shrug and walk away: we adapt our packing bench or source new containers in a hurry. Solutions aren’t always pretty, but they keep our partners rolling without missing their timelines.

    Enhancing Trust through Open Process and Regulation Compliance

    As Selegiline Hydrochloride finds its place in regulated pharmaceutical markets, our operations get regular scrutiny. We comply with GMP and local regulations not because of a checklist mind-set, but because process transparency is our security and our promise. Each step, from monitoring process parameters to recording deviations, lays open our plant to third-party audits. Regulatory inspectors, both announced and surprise, keep us diligent. Keeping full records—both digital and on paper—gives us confidence if questions arise months or years later. It builds a legacy of open proof, making each shipment more than just a product; it’s a documented promise that backs up every invoice and package.

    Looking Ahead: Manufacturing Improvements Never Stop

    Big improvements rarely come from expensive installations or top-down decrees. They emerge from small adjustments noticed by operators who spend every day at the line: switching out a filter, calibrating balances for extreme summer heat, asking the cleaning crew to double check storage jars. Next on our list: automating more batch records, digitizing critical process controls for real-time error flags, and running routine re-training for everyone on the shop floor, from new hires to old hands alike. Tackling bottlenecks is an endless job, but it’s also our main line of defense. A suggestion box in the lunchroom sometimes brings more fixes than any seminar.

    Standing Apart in an Overcrowded Market

    We’ve watched waves of new entrants chase this active ingredient, but real trust doesn’t come from banners or bulk discounts. It comes from factory crews that know what a bad batch looks like, who refuse to ship if a single QC check cocks an eyebrow, and from being honest about mistakes when they happen. Customers keep returning not for cut-rate sales, but for honesty—sharing real feedback, owning short shipments, and showing what happens behind closed production doors. As a manufacturer, these relationships outlast any marketing campaign.

    Practical Uses with Real Constraints

    Pharma-grade Selegiline Hydrochloride serves as a key intermediate for multiple drug delivery formats: tablets, capsules, transdermal patches. Hospitals and research clinics order it for experimental protocols. This means we can’t hide behind generic delivery options. Contract manufacturers need product tightly matched to their own blending and dissolution profiles, not just “meets standard.” We test variations—particle size, crystalline structure, flow measurements—before a lot reaches the market. Researchers ask for small packs for tests and stability studies. We make a point to accommodate, even when it disrupts line flows. Serving those needs means turning our process into something both scalable and flexible. It is production, but production with a memory for each new technical request.

    Summary Perspective

    Day in, day out, our team works not just for output but for repeatable success — product lots that bring no surprises, packaging that survives real-life shipping, and technical documents that withstand audit questions years down the line. We stake our reputation line-by-line, lot-by-lot. In manufacturing Selegiline Hydrochloride, lessons learned and challenges solved feed directly back into our process. We’ll keep it that way, because behind every bottle is not a slogan, but experience, pride, and a relentless drive to improve.