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L-(-)-Ephedrine

    • Product Name L-(-)-Ephedrine
    • Alias l_ephedrine
    • Einecs 200-012-6
    • 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

    112601

    Cas Number 299-42-3
    Molecular Formula C10H15NO
    Molecular Weight 165.23 g/mol
    Iupac Name (1R,2S)-2-(methylamino)-1-phenylpropan-1-ol
    Synonyms (-)-Ephedrine, L-Ephedrine, (-)-β-Methylamino-1-phenylpropan-1-ol
    Appearance White crystalline powder
    Melting Point 34-40°C
    Boiling Point 255°C at 760 mmHg
    Solubility Soluble in water, ethanol, and chloroform
    Specific Rotation [α]D20 −37° (c=1, H2O)

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

    Packing & Storage
    Packing The packaging for L-(-)-Ephedrine (25g) consists of a sealed amber glass bottle with tamper-proof cap and clear product labeling.
    Shipping Shipping of **L-(-)-Ephedrine** requires adherence to strict regulatory and safety protocols due to its classification as a controlled substance. It must be securely packaged, clearly labeled, and accompanied by relevant documentation. Only authorized, licensed entities may ship or receive it, with tracking and regulatory compliance ensured throughout transit.
    Storage L-(-)-Ephedrine should be stored in a tightly closed container, in a cool, dry, and well-ventilated area, away from incompatible substances such as oxidizing agents. It should be kept away from direct sunlight, moisture, and sources of ignition. Store at room temperature, typically between 15-25°C (59-77°F), and ensure proper labeling and access control to authorized personnel only.
    Application of L-(-)-Ephedrine

    Applications of L-(-)-Ephedrine in Industrial Manufacturing

    As an established manufacturer specializing in high-purity L-(-)-Ephedrine, we supply this active pharmaceutical ingredient for critical downstream manufacturing sectors. Our experience in controlled production, regulatory compliance, and traceable quality management enables precise supply for advanced formulation needs across regulated verticals. Below, we detail the principal industrial sectors where our material is effectively integrated, specifying application standards, incorporation ratios, processing stages, and finished product lines as implemented by major downstream manufacturers worldwide.

    1. Pharmaceutical Bronchodilator Formulations

    In pharmaceutical manufacturing, L-(-)-Ephedrine serves as a key component for the production of oral and parenteral bronchodilators addressing acute and chronic respiratory disorders. Formulators incorporate our material in strict accordance with pharmacopeial guidelines, optimizing concentrations to balance active delivery and safety profiles during granulation, blending, and tableting or solution preparation. Manufacturers utilize batch-to-batch analytical verification to ensure precise dosage and compliance at every stage.

    Industry compliance standards

    • United States Pharmacopeia (USP)
    • European Pharmacopoeia (Ph. Eur.)
    • Chinese Pharmacopoeia (ChP)
    • Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals (21 CFR 210/211)

    Typical usage ratio

    • 0.5%–1.2% by weight in solid dosage forms (adjusted by tablet size and target dose)
    • 10–25 mg per tablet or per injectable ampoule, formula dependent

    Downstream process integration

    • L-(-)-Ephedrine is directly charged into API blending vessels or solution reactors after dry milling and sieving. It is mixed with other actives, excipients, and processing aids prior to compression (tablets) or sterile filtration (injections).

    Final product types

    • Prescription bronchodilator tablets
    • Syrups for asthma relief
    • Injectable ephedrine solutions for acute treatment

    2. Nasal Decongestant OTC Drug Manufacturing

    OTC drug makers rely on our high-purity grade for incorporation in nasal decongestant solid and liquid formulations, maintaining conformity with consumer safety guidelines. L-(-)-Ephedrine is essential in the manufacture of combination cold tablets and nasal drops, requiring careful control in microdosing and homogenous distribution throughout batch production. Regulatory audits emphasize traceability and identity testing at both incoming and finished goods stages.

    Industry compliance standards

    • Food and Drug Administration (FDA) OTC Monograph M018: Nasal Decongestant Drug Products
    • British Pharmacopoeia (BP)
    • GMP for OTC Drug Manufacturing (ICH Q7)

    Typical usage ratio

    • Up to 0.125% by weight in nasal sprays and drops (0.5 mg–1 mg per dose)
    • Limited at a regulatory maximum per daily dose as per monograph control

    Downstream process integration

    • L-(-)-Ephedrine is dissolved in solvent and integrated during solution blending for liquid products, or triturated with dry excipients prior to tableting for oral forms. Downstream, the formulation undergoes microdosing filling and packaging with automated inspection.

    Final product types

    • Non-prescription nasal sprays
    • Oral cold/allergy combination tablets
    • Decongestant nasal drops

    3. Veterinary Pharmaceuticals for Respiratory Therapies

    Veterinary drug specialists include our L-(-)-Ephedrine in range of respiratory medications formulated for livestock and companion animals. These healthcare products demand consistent API quality and batch uniformity, aligning with veterinary pharmacopeia standards and regional animal health regulations. Formulation teams select incorporation ratios based on species-specific metabolism, and production plants utilize controlled mixing protocols to ensure safe, compliant finished goods.

    Industry compliance standards

    • Veterinary International Cooperation on Harmonisation (VICH GL9 GMP)
    • European Pharmacopoeia Veterinary Monographs
    • US FDA Center for Veterinary Medicine (CVM) Guidelines

    Typical usage ratio

    • 0.2–0.8% by weight, formulated per bodyweight-based dosing requirements for target animal species (for example, 1–5 mg/kg body weight in solution)

    Downstream process integration

    • L-(-)-Ephedrine is added post-sterilization in aqueous solutions or blended into premixes for oral powder feed additives, followed by strict homogeneity testing and final sterile packaging.

    Final product types

    • Respiratory aid oral solutions for veterinary use
    • Pulmonary health feed additives
    • Veterinary injectable formulations

    4. Manufacture of Active Pharmaceutical Ingredient (API) Intermediates

    API manufacturers downstream utilize our L-(-)-Ephedrine as a chiral precursor in multi-step synthesis of secondary pharmaceutical actives. Integration involves tightly controlled process conditions to maintain stereochemical integrity throughout derivatization and salt conversion. In these applications, traceability and impurity profiling remain critical for process release and regulatory filing according to target molecule requirements.

    Industry compliance standards

    • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
    • Relevant pharmacopoeia registration (USP, JP, Ph. Eur.) for each specific API
    • DMF (Drug Master File) filing for precursor traceability

    Typical usage ratio

    • Stoichiometric equivalent to desired product yield—typically 1.1–1.3 molar equivalents, tuned for conversion efficiency in chiral step

    Downstream process integration

    • L-(-)-Ephedrine is introduced during the initial synthetic reaction or resolution step for chiral amine intermediates, followed by stepwise chemical transformations, solvent switching, and purification via chromatography or crystallization.

    Final product types

    • Chiral API intermediates for further active synthesis
    • Enantiomerically pure pharmaceutical building blocks
    • Bulk intermediates supplied for custom synthesis contracts

    5. Diagnostic Laboratory Reagent Production

    Clinical reagent manufacturers leverage our high-purity L-(-)-Ephedrine batch lots as an analytical calibrant or component in assay buffer blends for in-vitro diagnostic kits. These applications demand ultra-low impurity profiles and full material traceability, with strict adherence to in-vitro diagnostic device (IVDD) regulatory protocols. Process engineers manage solution preparation, quality verification, batch coding, and sterile dispensing for controlled lot performance.

    Industry compliance standards

    • ISO 13485 (Medical Device Quality Management)
    • IVDD regulation (EU 98/79/EC for in vitro diagnostics)
    • US FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices)

    Typical usage ratio

    • 10–100 μg/mL in buffer systems or 5–20 μg per test reagent cartridge, adjusted according to analytical method sensitivity

    Downstream process integration

    • L-(-)-Ephedrine is weighed, dissolved, and introduced into diagnostic solution reservoirs, then dispensed into kit vials or test cartridges using automated filling systems under HEPA-filtered conditions.

    Final product types

    • Clinical chemistry assay kits containing ephedrine calibrators
    • Reference reagent sets for toxicology panels
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    Certification & Compliance
    More Introduction

    L-(-)-Ephedrine: Factory Insights Into a Tried-and-True Compound

    Understanding L-(-)-Ephedrine as a Chemical Manufacturer

    In the crowded landscape of pharmaceutical intermediates and fine chemicals, L-(-)-Ephedrine occupies a unique space. Every kilogram moved through our production line carries decades of insights in crystallization techniques, stable storage conditions, and purification. We see it not just as a substance, but as the culmination of careful process choice and years of improvements. The product, known in some circles by its chemical profile C10H15NO with CAS number 299-42-3, consistently draws attention because of its clean stereochemistry and proven application in pharmaceutical and specialty chemical sectors.

    L-(-)-Ephedrine does not behave like an off-the-shelf chemical. It stems from strict optical purity requirements. In our plant, chiral separation and isomer monitoring never leave the floor. For manufacturers who need reliable input for critical syntheses, these features matter more than any marketing phrase. It’s not a fancy story; it’s about results batch after batch. Our team never cuts corners on recrystallization or impurity tracing, because even the smallest deviation undermines end-use confidence.

    Specifications: From Bulk Quantities to Precision Batches

    We produce L-(-)-Ephedrine hydrochloride as pure white crystalline powder, with attention to melting point and moisture content every single run—not just through occasional QA checks. Chemical purity runs above 99%, with optical rotation measured directly at the plant before any packaging. In real practical terms, we not only provide documented proof for these metrics but welcome visitors who run QC tests directly on our production floor.

    Moisture analysis, residual solvent checks, and absolute enantiomer identity become recurring daily routines. The team scrutinizes every drum for color, particle flow, and odorous notes so no batch creates issues down the line for customers sensitive to contamination. High-purity materials reduce process downtime and avoid the need for redundant purification, which saves time and budget in high-throughput environments. Quantities start at several kilograms, but we maintain flexibility for customers who need both small research-scale bottles and full-scale production shipments.

    Real-World Use Cases and Industry Experiences

    Pharmaceutical companies seek out our L-(-)-Ephedrine for both API synthesis and as a chiral auxiliary. Bronchodilators and decongestant formulations make up the main end-product streams. Over the years, we’ve witnessed a steady shift toward high-specificity synthetic methods relying on enantiomerically pure compounds rather than racemic blends.

    Our L-(-)-Ephedrine frequently enables targeted beta-adrenergic receptor activity when formulated as part of larger drug molecules. This single stereoisomer delivers the physiological action required for prompt, reliable results—substantially different from mixed ephedrine, where inconsistent responses and regulatory concerns complicate downstream use. Several customers have shared how switching away from racemic or lower-purity material freed up their QA teams and allowed easier regulatory submissions.

    Comparing to Alternatives: Why Stereo-Purity Tells the Story

    Any manufacturer familiar with this category faces a choice: source racemic forms, opt for synthetic analogues, or select pure L-(-)-Ephedrine. Racemates may cost less up front but produce wider variation in therapeutic effects, alongside tighter regulatory scrutiny. Our experience shows that by investing in chiral purity, manufacturers remove much of the guesswork. Chiral HPLC, polarimetry, and impurity profile documentation all emerge as regular features in our QC lab—not just for auditors, but for day-to-day efficiency.

    DL-ephedrine and D-(+)-ephedrine carry different physiological effects and can trigger varying responses once incorporated into drug formulations. Our technical staff regularly receives requests for analytic comparisons and side-by-side documentation to satisfy both R&D and regulatory officers, especially in multinational operations. By showing real-time purity and identity testing, we give formulation scientists and compliance teams the confidence to build protocols around absolute L-(-)-Ephedrine, reducing out-of-spec incidents and smoothing the path for product registrations.

    Manufacturing Realities: From Raw Input to Finished Powder

    Laboratories and production chemists face unique challenges translating theory to a reliable industrial outcome. On our floor, traceability begins with the raw botanical or synthetic feedstocks. Extraction or stepwise synthesis follows tightly scripted batch records overseen by operators who have skin in the game. In-process controls—chiral purity by HPLC, melting point checks, Karl-Fischer moisture titration—catch deviations before they threaten the final product. If a run trends outside expected optical rotation, the lot gets segregated before primary filtration.

    Those details become especially critical when customers use L-(-)-Ephedrine to build more complex active molecules. Even slight shifts in optical rotation can disrupt downstream synthesis, rendering entire batches of work unusable. The process does not simply stop with finishing a lot; it extends through drum storage, transfer, and logistics. Each batch receives authentication by an experienced QC team using NMR and HPLC against retained reference samples.

    Why Fine-Tuning the Process Matters

    Over years of manufacturing, incremental improvements accumulate. Tiny tweaks in temperature control or chiral catalyst choice change more than a single batch’s statistics—they reshape the way clients trust our product in high-value pharmaceutical campaigns. Most clients using L-(-)-Ephedrine cannot afford off-spec material or unresolved contamination, as reactions may take days or weeks, and a rejection at the finish wastes enormous resources. Consistency eliminates that risk, time after time.

    Old habits die hard, though. Some downstream users still try sourcing through traders or less-controlled supply chains, only to return after discovering contamination or regulatory grey zones. We have seen repeatedly how properly documented and tightly monitored material prevents importing or export issues, particularly under changing regulatory conditions.

    Storage, Longevity, and Plant Learnings

    We have learned that improper storage ruins even the best-made product. Humidity or temperature fluctuation degrades L-(-)-Ephedrine, opening the door to decomposition or crystallization changes. That is why we dedicate a controlled area for short-term and long-term storage, monitoring climate data every hour.

    Customers who ignore transportation temperature controls often experience caking, color change, or solvent loss—problems solved by simple but hard-earned preventive routines. Selling is only half the job; ensuring the product arrives with the same profile as the QC sample is the rest.

    End-User Feedback and Process Refinement

    We regularly invite pharmaceutical partners to audit our production flows. Feedback from end-users directly influences batch scale, particle size optimization, and packaging formats. Research teams have shared how a narrow particle-size distribution eases their compounding and blending steps, speeding up bench trials and process validation.

    On several occasions, clients—especially those running powder blending or tableting—request tighter particle size specification. In those cases, we reshape crystallization and drying protocols, using feedback to refine the downstream handling characteristics of finished material. This two-way conversation shortens development cycles for finished drug products and avoids expensive reformulation.

    Regulatory Navigation and Documentation

    Regulatory expectations around ephedrine and related compounds remain strict and dynamic. We follow requirements under national and international frameworks, offering product with full traceability and batch documentation. Material safety data, certificates of analysis, and audit trails accompany every shipment. Pharmaceutical partners value documented process transparency, especially when pursuing international registrations or dossiers.

    We do not simply check regulatory boxes. Internal process records, staff training logs, and in-process monitoring systems pave the way for seamless regulatory audits. Our site has withstood surprise inspections, DEA reviews, and multi-jurisdictional standard updates. Customers rely on this level of preparedness for their own compliance goals, because changing rules no longer cause panic or unexpected rework.

    Supporting the Pharmaceutical Pipeline

    Several clients involved in new drug development use L-(-)-Ephedrine as a vital enantiopure starting material for synthesis. In medicinal chemistry and pilot campaigns, they need full confidence that each ampoule or drum reflects the actual specification. Our technical staff provide direct support to R&D teams, troubleshooting unusual observations like solubility changes or off-odor batches in their test runs.

    In some therapeutic areas, the route to scale-up hinges on access to high-purity starting materials. Early dialogue with process scientists helps us understand and address pain points—whether solubility or stability—well before commercial production. We do more than ship drums; we troubleshoot, adapt, and provide data long before the first clinical trial.

    Industry-Driven Advances and Future Perspectives

    L-(-)-Ephedrine’s role has evolved. Once, natural sources dominated; now, synthetic routes allow better impurity control and reduce agricultural variables. Our facility has adopted enzymatic and asymmetric synthetic methods, giving downstream users material with less batch-to-batch variation and higher environmental profile. These advances lower risks from plant-sourced contaminants and ease the approval process for international markets.

    Industry demand cycles, from seasonal medicine manufacturing to global pharmaceutical campaigns, push us to keep flexible safety stocks and quick turnaround capabilities. This experience lets us weather supply chain troubles—be they raw input disruptions or sudden regulatory shifts—while keeping clients in production. Order flows no longer stop or slow down because we ignored upstream signals or misjudged market planning.

    Addressing Challenges and Providing Solutions

    Some challenges never fully disappear. Raw material inconsistencies, changing solvent rules, shifts in compliance standards, or logistics hiccups all test the mettle of a true manufacturer. Our response centers on tight process control, daily review of plant analytics, and proactive outreach to key clients. Whenever a batch triggers unusual test results, we have the flexibility to halt, review, and resolve before any downstream work begins.

    Redundant in-process checks sound expensive, but they often prevent more wasted material and time. Simple, hands-on operator training sessions, regular recalibration of analytical instruments, and investment in modern packaging all minimize uncontrolled variables. These changes might come from expensive failures experienced years ago, but the result is a product lineup that stays reliable even as operating conditions shift.

    Customer Relationships and Knowledge Exchange

    Over the years, we learned that working as a partner, not just a supplier, produces better outcomes all around. One multinational customer struggled with delayed validation times after switching new lots for tablet manufacturing. By inviting their technical team onto our production site, and sharing process data in real time, we built a troubleshooting bridge that led to both faster release and better quality. These collaborations feed right back into our own internal training and process improvements.

    Open conversation among experienced chemists—on both sides of the order—beats back-and-forth firefighting and repetitive non-conformance reports. When customers trust that deviations will be documented, investigated, and explained without excuses, the business relationship endures high-pressure market cycles and changing regulatory flags.

    Environmental Responsibility in Manufacturing Practice

    The path from raw material to finished L-(-)-Ephedrine often generates environmental concerns. Our team runs solvent recycling systems, tracks effluent profile, and measures energy inputs with every campaign. Not because of abstract targets, but because local inspectors, employees, and neighbors expect it. Reduced solvent load and responsible process design work best when implemented gradually through regular review and commitment.

    Many of our clients now prioritize sustainability certifications and expect visible efforts around green chemistry. By progressively shifting toward closed-loop systems and minimizing hazardous byproducts, we pass that benefit on to clients who need low-impact supply chains for themselves and end users.

    Key Differentiators: More Than Just a Molecule

    L-(-)-Ephedrine is defined by more than its chemical skeleton. Its real value emerges in how it fits into clients’ actual manufacturing and R&D practices. Single-enantiomer purity brings consistency, reproducibility, and regulatory simplicity. Batch documentation, technical support, and transparent analytics push product reliability far beyond what generic or racemic forms offer.

    What sets factory-direct supply apart is not only lower risk of cross-contamination compared to traders or resellers, but genuine technical understanding of the challenges end-users face. Customers regularly remark that switching to material produced and handled under direct manufacturer oversight ends up reducing their costs and facilitating market registrations, even as upfront pricing may not always look the lowest on paper.

    Future Trends and Real-World Lessons

    The global chemical scene never stands still. Demand patterns for ephedrine derivatives shift seasonally and with market trends. Regulations around precursor controls and documentation remain strict and show signs of further tightening. Lessons learned in our plant—especially the value of preemptive quality management—continue to shape product and process direction.

    Feedback loops with customers, industry networks, and regulators mean facility and process upgrades never stop. They recalibrate through every audit, every returned drum, every late-night troubleshooting call with pharmaceutical partners. By sharing these lessons across our production and technical support teams, we keep improving product quality and reliability for the next wave of market demand.