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(S)-(-)-Propranolol Hydrochloride

    • Product Name (S)-(-)-Propranolol Hydrochloride
    • Alias (S)-(-)-Propranolol HCl
    • Einecs 259-957-3
    • 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

    689088

    Chemical Name (S)-(-)-Propranolol Hydrochloride
    Cas Number 13071-98-0
    Molecular Formula C16H21NO2·HCl
    Molecular Weight 295.80 g/mol
    Appearance White to off-white crystalline powder
    Purity Typically ≥98%
    Optical Rotation [α]20/D = -32° to -36° (c=1, H2O)
    Solubility Soluble in water and methanol
    Melting Point 163-166°C
    Storage Temperature 2-8°C (Refrigerated)

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

    Packing & Storage
    Packing White, tamper-evident bottle labeled "(S)-(-)-Propranolol Hydrochloride, 5 grams," with hazard symbols, batch number, and safety information.
    Shipping (S)-(-)-Propranolol Hydrochloride is shipped in tightly sealed containers, protected from light and moisture, with appropriate labeling. The chemical is handled according to safety regulations, typically via express or standard courier, and may require temperature control and hazardous material documentation depending on regional and international shipping guidelines.
    Storage (S)-(-)-Propranolol Hydrochloride should be stored in a tightly closed container, protected from light and moisture. Keep it at a cool temperature, ideally between 2–8°C (refrigerated) or as specified by the supplier. Ensure the storage area is well-ventilated and designated for chemicals. Avoid exposure to heat, incompatible substances, or direct sunlight to maintain stability and potency.
    Application of (S)-(-)-Propranolol Hydrochloride

    Applications of (S)-(-)-Propranolol Hydrochloride in Industrial Manufacturing

    (S)-(-)-Propranolol Hydrochloride serves as a critical chiral intermediate and active ingredient across several regulated downstream sectors. As an original manufacturer, we supply this material with full traceability for advanced chemical synthesis, specialty pharmaceutical development, and precision analytical applications. Below, we detail major industrial manufacturing uses based on strict compliance and technical workflow needs.

    1. Active Pharmaceutical Ingredient Synthesis for Beta-Blocker Tablets

    Leading pharma companies employ (S)-(-)-Propranolol Hydrochloride as the exclusively active beta-blocker enantiomer in oral solid dosage formulations for cardiovascular therapeutics. Manufacturers require reliable enantiopurity, with this intermediate undergoing controlled conversion to final API via validated crystallization and downstream granulation steps before compression into tablets. Internal and batch-to-batch purity assessment remains critical to ensure consistent release characteristics, especially as major brands target paediatric and adult hypertension management and arrhythmia prevention protocols in regulated global markets.

    Industry compliance standards

    • ICH Q7 GMP guidelines for active pharmaceutical ingredient production
    • US FDA 21 CFR Part 211 cGMP for finished pharmaceuticals
    • European Pharmacopoeia Monograph 01/2017:0853 for Propranolol Hydrochloride
    • Chinese Pharmacopoeia (ChP) 2020 standards for cardiovascular agents

    Typical usage ratio

    • Used at 50–160 mg per tablet blend; adjustment based on finished dosage strength and desired release profile
    • Enantiomeric purity maintained ≥99.5%

    Downstream process integration

    • Integrated after granulation as a direct API input prior to tableting or encapsulation
    • Quality tested for residual solvents and assay prior to blending

    Final product types

    • Hypertension control tablets and capsules
    • Antiarrhythmic oral medications for pediatric and adult sectors
    • Prophylactic migraine management tablets

    2. Chiral Intermediate for Custom Synthesis and Contract Manufacturing

    Contract development and manufacturing organizations (CDMOs) use (S)-(-)-Propranolol Hydrochloride as a source of single enantiomer building blocks in scalable synthesis of bespoke beta-blocker derivatives and analogs. These specialized projects require high-throughput chiral input for esterification, amidation, or salt-formation protocols, supporting innovation in research-scale to commercial-scale supplychains. Inline chiral HPLC and impurity profiling remain critical throughout scale-up and release for advanced intermediate delivery.

    Industry compliance standards

    • ICH Q11 for development and manufacture of drug substances
    • ISO 9001:2015 certified QMS for custom synthesis projects
    • Regulatory compliance with customer-specific DMF (Drug Master File) requirements

    Typical usage ratio

    • Usually 0.1–0.9 molar equivalents per batch dependent on target molecule structure
    • Stereochemical purity held at ≥99% enantiomer excess (ee)

    Downstream process integration

    • Enters reactor vessels after pre-stage purification in multi-step organic synthesis
    • Used for downstream chiral derivatization, reduction, or salt formation

    Final product types

    • Novel beta-adrenergic receptor antagonist candidates
    • Multi-stage key intermediates for global ANDA / NDA submissions
    • API analogues for exclusive pre-clinical or patent expansion projects

    3. Control Standard and Reference Material in Pharmaceutical Quality Control

    Regulatory laboratories and pharmaceutical quality units rely on (S)-(-)-Propranolol Hydrochloride as an ISO/IEC 17025 traceable control standard. These reference materials allow precise calibration of analytical instruments for chirality determination, identity tests, and dissolution studies of drug products. The reference input supports system suitability, validation, and ongoing batch release in line with global pharmacopoeia requirements, with manufacturers guaranteeing certified purity, moisture content, and stability documentation with every supply lot.

    Industry compliance standards

    • USP and EP reference material guidelines
    • ISO/IEC 17025 for calibration laboratory processes
    • FDA and EMA Data Integrity Guidance for chromatographic analysis

    Typical usage ratio

    • Standard input weighs 10–200 mg per calibration depending on assay technique
    • Stored under controlled humidity (≤0.5% moisture) for ongoing stability

    Downstream process integration

    • Directly dissolved for HPLC or GC analysis in QC release labs
    • Used as a single-use or routine system suitability control in finished product validation

    Final product types

    • Certified calibrants and reference vials for QC labs
    • Calibration kits for regulatory audits
    • Analytical documentation packages for regulatory submissions

    4. Enantiopure Building Block for Research Chemical Markets

    Specialty research organizations, university laboratories, and R&D divisions of life science firms procure (S)-(-)-Propranolol Hydrochloride as a key chiral scaffold. It enables mechanistic studies on beta-adrenergic pathways, racemization kinetics, and receptor binding models. Material supports academic funding projects and advanced pharmacological research, often subject to precise small-scale dissolution, re-crystallization and NMR/LC-MS analysis under laboratory GLP standards. Accurate supply documentation and MSDS certification accompany deliveries for safe, compliant use.

    Industry compliance standards

    • OECD Good Laboratory Practice (GLP) for research use
    • Institutional chemical safety and hazardous substance registration protocols
    • Local customs and import certification for research chemicals

    Typical usage ratio

    • 10–500 mg per experiment set, variable with assay conditions
    • Concentration prepared from analytical standard to solution-based routines (0.1–10 mmol/L)

    Downstream process integration

    • Dispensed in fumehood environments for direct dissolution in buffer or DMSO
    • Applied for chiral separation, derivatization, or receptor binding assays

    Final product types

    • Research grade chiral standards for academic laboratories
    • Assay-specific test kits for receptor and transport studies
    • Mechanistic chemical series for publication and pre-clinical investigation

    5. Calibration Agent for Analytical Instrument Manufacturing

    Producers of analytical equipment—HPLC, capillary electrophoresis, and mass spectrometry systems—employ (S)-(-)-Propranolol Hydrochloride in instrument calibration, test kit compilation, and post-sale system verification. It provides a known chiral reference point for detector sensitivity checks, column performance evaluation, and calibration certificate generation. Manufacturers source this raw material with a focus on stability, long-term storage capability, and detailed characterization data sheets for B2B instrument packages.

    Industry compliance standards

    • ISO 17034 General Requirements for Reference Material Producers
    • Relevant IEC standards for analytical instrumentation testing
    • REACH registration for supply within the European Union

    Typical usage ratio

    • 10–100 mg per calibration cycle; adjusted for instrument volume and test frequency
    • Chiral concentration typically 5–100 μg/mL in calibration mixtures

    Downstream process integration

    • Pre-packaged or dispensed into vials for customer use in on-site calibration
    • Integrated into multi-parameter test kits or system start-up protocols

    Final product types

    • Pre-calibrated instrument kits
    • Reference test solutions for laboratory equipment
    • OEM-certified calibration vials for global instrument markets
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    Certification & Compliance
    More Introduction

    (S)-(-)-Propranolol Hydrochloride: Built on Experience and Precision Chemistry

    Making Medication Reliable, Every Batch

    In every reactor and filtration column, (S)-(-)-Propranolol Hydrochloride carries a story of attention to detail. From years of measurement and strict process control, our team learned the right temperature profiles, solvent choices, and crystallization times to turn a theoretical molecule into a tangible and consistent ingredient for critical medicines. This is not a product assembled by chance—it is the result of problem-solving, repeated analysis, and an ongoing relationship with people who formulate finished drugs. Understanding the pressure our customers face to deliver reliable generics and branded formulations, we set standards in both chiral purity and particle size so downstream blending and tableting remain trouble-free.

    Pursuing Purity: Aiming Beyond Regulatory Lines

    Anyone can cite compliance with pharmacopoeia or a certificate of analysis, but the real challenge lies in consistency across years and lots. It never pays to get comfortable with “just meeting” the specs. With (S)-(-)-Propranolol Hydrochloride, our method validation involves redundant checks for residual solvents, optical rotation, and assay by HPLC with chiral columns calibrated weekly. Because we manufacture at scale, even minor process drifts can echo through every drum and foil bag. Our technicians check purity and enantiomeric excess repeatedly under real-world production conditions, not just during pilot runs. This discipline cuts down on customer complaints, failed batches, and wasted time at the downstream formulation site.

    What Sets This Enantiomer Apart

    (S)-(-)-Propranolol Hydrochloride is not a generic catch-all. Its single optically active configuration behaves differently than the racemic mix or the R-enantiomer. The S-form binds the beta receptors in the cardiovascular system with higher potency, which brings a sharper therapeutic benefit and dosing precision. For projects focused on minimizing active ingredient loads without loss of effect, this characteristic matters. Over the years, we refined our route to limit PTC (phase transfer catalyst) contamination, excess sodium, and color body impurities, because these play havoc in chiral separations and create headaches during scale-up. Our control over the optical purity (often exceeding 99%) comes from both raw materials and strict control at every step, not an afterthought in the lab.

    Quality Backed by Practical Know-How

    Laboratory precision and real-world reliability live side by side in a manufacturing environment. Many may not realize every lot we release must match not only our internal certifications but also the feedback and audit findings from customers’ own QC teams. We spend time reviewing the feedback—how a lot handled under their mixers, whether tablets pressed evenly, whether the flowability created any challenges. This feedback loops back into our adjustments for moisture content, dehydration protocols, or micronization settings during milling. (S)-(-)-Propranolol Hydrochloride leaves our floor only after meeting batch records built from these decades of accumulated experience.

    Knowing the Difference: Our Route vs. Commodity Outputs

    The market holds both opportunity and risk. Some producers race for volume, cranking product through with less focus on resolving impurities unique to (S)-(-)-Propranolol Hydrochloride—especially those coming from incomplete resolution or side-products in the key chiral step. We stick to a route established in technical consultation with experienced chemists and process engineers, which limits formation of troublesome byproducts like dichloropropanol or substituted naphthalene derivatives. This reduces downstream challenges for formulators and slims the odds of cGMP deviations. Our investment in isolation by fractional crystallization rather than “quick fix” solvent washes means customers experience less lot-to-lot variation in tablet performance or dissolution times.

    Meeting Industry Needs, Not Just Regulatory Footnotes

    We watched demand for single-enantiomer APIs expand as doctors and regulatory groups aim at better patient outcomes and safer therapies. Chiral specificity matters more than ever, even as production costs rise and timelines tighten. Our production team members have seen how a careless cleaning sequence or a shortfall in vacuum pulls can seed future quality issues. By prioritizing staff training and equipment maintenance over cut-rate expansion, we deliver consistency in (S)-(-)-Propranolol Hydrochloride, batch after batch. Buyers dealing with unpredictable global supply chains deserve suppliers who maintain these production values even under pressure.

    Supporting Formulators—It’s Not Just About the API

    Experience in real-world projects taught us that a shipment of (S)-(-)-Propranolol Hydrochloride isn’t just a chemical delivery—it is the start of a process chain where things will go right or wrong based on the work we do. Some of our customers handle high-throughput tablet presses; others prepare sustained-release capsules that react sensitively to particle size distribution. Before finalizing specifications, we work with development teams to examine blending behavior, compatibility with typical excipients, and the effect on moisture-sensitive granulation steps. Batch reports track trends in flowability and compressibility so formulators don’t face sudden surprises.

    Understanding User Needs and Industry Trends

    The health landscape shifts; generic competition grows, regulatory expectations mount, and every link in the supply chain is expected to deliver more reliability than ever before. Our awareness of industry pain points comes from listening: supply lags, changing pharmacovigilance criteria, pressure on inventory costs. We adjust our production runs not just by market demand but by anticipating the specific dosing forms our customers prepare, whether low-dose pediatric pills or long-acting extended-release products. This responsiveness guides decisions on particle size, packaging stability, and even drum weight.

    Environment, Health, and Process Safety in Every Batch

    Manufacturing complex molecules calls for practical hurdles to be anticipated and solved one at a time. Working hands-on with hazardous solvents or high-energy intermediates means a focus on both operator safety and final API cleanliness. We phase out legacy reagents as cleaner alternatives appear on the market, even when this means reworking process validations. Waste streams are monitored continuously for potential off-gassing or problem pH levels, because a plant’s performance is only as good as how it treats its operators, its neighborhood, and the product going out the door. Production records carry signatures from process and EHS teams who understand (S)-(-)-Propranolol Hydrochloride not just as a commodity but as a potential risk if handled carelessly.

    Building Through Thorough Documentation

    Years of audits from regulatory authorities and multinational clients shape the way we document and track our entire manufacturing process. Out-of-spec findings do not get swept under the rug, but get logged and traced back to root causes. Every batch of (S)-(-)-Propranolol Hydrochloride comes with a cross-referenced trail from starting materials, reagent lots, filtration times, and chiral column runs, checked against industry benchmarks and regulatory updates. This diligence protects our partners downstream—if questions arise on a release test or an impurity spike, we provide the historical data to solve issues before they reach the pharmacy shelf.

    The Value of Direct Manufacturer Relationships

    Years dealing with new trends in medicine taught us that stability in supply beats even the most attractively-priced one-off shipments. Direct connections between API makers and pharmaceutical clients mean troubleshooting gets addressed quickly. Instead of losing weeks to speculation, formulators and QA teams reach our chemists and production engineers directly to address batch-specific questions. These relationships inform us on unique project constraints, seasonal swings in demand, and regulatory challenges in different jurisdictions. Feedback loops speed up process upgrades and minimize repeat incidents.

    Consistent Specifications, Informed by Field Use

    We don’t chase radical changes to specifications without good cause. Every modification to our standard (S)-(-)-Propranolol Hydrochloride—altered particle size, spike in assay, revised moisture—comes only after consultation with users who apply it daily. Lessons from scale-up failures, tablet capping, or solubility challenges on the formulation floor translate into data we use to dial in specifications between lots. We run parallel test samples to track stability under different conditions, learning which variables translate to shelf-life or performance risk. This hands-on feedback guides every process optimization before wider adoption.

    Supporting Innovation Without Losing Sight of Safety

    Sometimes formulators aim to push the envelope by integrating (S)-(-)-Propranolol Hydrochloride in new dosage forms or novel drug delivery systems. From experience, we know every new idea invites unforeseen pitfalls. Blends may segregate, dissolution rates dip, or side reactions become amplified at scale. Our technical support team works alongside client R&D chemists—testing compatibility with different excipients, checking for trace-level contaminants, and monitoring for any deviation in chiral purity. These real-world trials anchor every release batch in evidence and knowledge, rather than assumptions.

    Why Process Matters in Chiral Drug Synthesis

    Years ago, chiral synthesis was seen as an arcane art, with high loss rates and limited scale. The leap to commercial (S)-(-)-Propranolol Hydrochloride production came as analytical tools improved and production teams learned how to stabilize the process against real-world variability. We learned that minor temperature swings, solvent grades, or the wrong stirring speeds could nudge the process off target, diluting chiral purity and opening up the risk of unwanted side-products. By building feedback into every stage—inline monitoring, batchwise chiral HPLC, and regular instrument calibration—our process guards against these shifts. This kind of control grows from both digital instruments and the eyes and ears of experienced chemists.

    Focus on Scalability and Realistic Business Continuity

    Large batch manufacturing only works when every step can be audited and repeated under varied market and weather conditions. Power fluctuations, delivery delays for key solvents, or sudden regulatory notifications disrupt the best-laid plans. Our investment in backup utilities, dual-sourcing of critical raw materials, and expanded storage facilities translates to fewer missed shipments for our partners. Scalability means more than just ‘making it bigger;’ it means flexible, resilient production that adapts to customer needs without compromising safety or regulatory standards.

    Data-Driven Improvements Rooted in Operator Experience

    No process stays locked forever. Our supervisors listen to suggestions from operators who notice slight changes in powder flow, filtration rates, or color during crystallization. Regular maintenance schedules, cleaning validations, and statistical process control all flow from this grassroots feedback. Our plant automation—integrating real-time process analytics—arose not from wishful thinking, but from years observing where human error or equipment drift introduced recurring headaches. By investing in these systems, (S)-(-)-Propranolol Hydrochloride production runs smoother, with less risk of deviations sneaking past unnoticed.

    Technical Collaboration with Downstream Users

    Our involvement rarely ends with shipping a drum. As partners experiment with new formulation techniques or address regulatory shifts, our chemists step in to test sample transfers and screen for possible impurities. We conduct side-by-side trials in actual formulation lines, offering support in handling, flow, or compaction issues specific to our product’s behavior. This practical support underpins successful product launches and process scale-up, reducing wasted resources and last-minute changes.

    Bridging the Regulatory Divide

    From audit to batch release, regulatory due diligence shapes every business relationship. Our documentation teams stay ahead of evolving guidelines, making sure all certificates, analytical reports, and batch records meet global expectations. Experience tells us that regulatory burdens pile up when details get missed: overlooked solvents, ambiguous batch traces, or inconsistent impurity profiling. Bringing clarity and thoroughness to (S)-(-)-Propranolol Hydrochloride paperwork reduces downstream hassle for regulatory filings and site inspections.

    Packaging That Reflects Real Distribution Needs

    Bulk packaging for APIs often seems like an afterthought until temperature or humidity swings hit storage and transport. Having dealt with recalls from moisture uptake or particle clumping, we developed packaging and shipment standards for (S)-(-)-Propranolol Hydrochloride that hold up from production line to warehouse floor. We use triple-layer barriers and desiccant-laden drums, checking each batch for water activity and oxygen exposure risks. These practices might add modest cost, but over the product’s journey, this stable protection prevents much greater loss.

    Long-Term Investment in People and Process

    Our company only works because of the experts who run the chemical reactors, operate the HPLC columns, and sign off on batch logs. Neglecting skills training, equipment upgrades, or support for safety managers would spell long-term trouble. Investment in ongoing certification, process seminars, and hands-on troubleshooting builds not just technical skill but a workplace where everyone notices small details. From simple weighing errors to complex filtration bottlenecks, the team’s vigilance keeps the manufacture of (S)-(-)-Propranolol Hydrochloride smooth and mistake-free.

    Meeting Challenges and Maintaining Trust

    Global shortages, shifting market prices, and new competitor entries shift the API business every year. Our approach keeps quality at the center—basing improvements on feedback from regular users and investing in systems that keep mistakes from snowballing across batches. Health professionals and production chemists alike require product consistency, technical transparency, and a willingness from the manufacturer to back up their product both scientifically and practically. Each shipment of (S)-(-)-Propranolol Hydrochloride represents a tribute to that expectation—one earned over years of close work and a steady focus on practical innovation.