Doxylamine succinate 99% High Purity Pharmacy Grade White Raw Power 562-10-7

Propylparaben More Info

Doxylamine succinate (CAS 562-10-7) is an ethanolamine-class antihistamine renowned for its pronounced sedative properties. As the succinate salt of doxylamine, this compound offers enhanced stability and solubility compared to the free base, making it ideal for pharmaceutical formulations. Its molecular structure features an ethanolamine side chain connected to a pyridyl ring system, which facilitates strong binding to histamine H1 receptors. We supply high-purity doxylamine succinate that complies with major pharmacopoeial standards, serving as a reliable active ingredient for sleep aid and short-term sedative applications.

Mechanism of Action and Pharmacological Profile

Doxylamine succinate functions as a competitive inverse agonist at central histamine H1 receptors, effectively blocking the wake-promoting effects of histamine in the brain. This action results in significant depression of central nervous system activity, leading to its characteristic sedative effects. The compound demonstrates additional activity as a muscarinic antagonist, contributing to its side effect profile while enhancing its sedative potency. With a rapid onset of action typically within 30 minutes and a half-life of approximately 10 hours, it provides effective sleep maintenance throughout the night.

Primary Therapeutic Applications

The predominant application of doxylamine succinate is in over-the-counter sleep aid medications for the relief of occasional insomnia. It is also widely utilized in combination with analgesics such as acetaminophen in nighttime cold and flu formulations to alleviate symptoms and promote rest. Additionally, the compound finds application in antiemetic preparations for nausea management, though this use has declined in favor of newer agents with improved side effect profiles. Its reliable sedative effect makes it particularly valuable in formulations designed to address sleep difficulties associated with transient conditions.

Formulation Versatility and Compatibility

Our doxylamine succinate is compatible with a wide range of pharmaceutical excipients and can be incorporated into multiple dosage forms including immediate-release tablets, capsules, and oral liquid solutions. The compound demonstrates excellent compressibility for direct compression tableting and maintains stability in both aqueous and non-aqueous vehicles. We provide comprehensive compatibility data to support formulation development and can recommend optimal excipient systems to enhance stability and bioavailability in finished products.

Quality Specifications and Regulatory Compliance

We manufacture doxylamine succinate to meet or exceed USP, EP, and BP monograph requirements, with typical purity specifications of not less than 99.0%. Rigorous controls are implemented for related substances, residual solvents, and heavy metals. Our manufacturing process employs GMP standards throughout, and each batch is accompanied by a comprehensive Certificate of Analysis. The compound is approved for over-the-counter use in most major markets, and we provide full regulatory support documentation for customer submissions.

Safety Profile and Precautions

While generally safe when used as directed, doxylamine succinate carries precautions typical of sedating antihistamines. Common adverse effects include next-day drowsiness, dry mouth, dizziness, and urinary retention. Contraindications include concomitant use with alcohol or other CNS depressants, monoamine oxidase inhibitor therapy, and certain respiratory conditions. Proper labeling should include warnings about operating machinery or driving after ingestion. We provide complete safety data sheets and toxicological information to support appropriate risk-benefit assessment in product development.

Stability and Storage Recommendations

Doxylamine succinate demonstrates excellent long-term stability when stored in well-closed containers protected from light and moisture at controlled room temperature. Accelerated stability studies confirm maintenance of potency and purity under typical storage conditions for at least 36 months. The compound is stable across the pH range typical of oral solid and liquid dosage forms, though protection from excessive heat is recommended during manufacturing and storage to prevent degradation.

Market Position and Industry Trends

Doxylamine succinate maintains a strong position in the global sleep aid market, valued for its established efficacy and favorable safety profile compared to prescription alternatives. Market growth is driven by increasing consumer preference for self-care solutions for sleep management and expanding retail availability of OTC sleep products. As patent protections expire on newer prescription insomnia treatments, the cost-effectiveness of doxylamine-based products represents a significant competitive advantage in both developed and emerging markets.

Packaging and Supply Chain Capabilities

We offer doxylamine succinate in industry-standard packaging including double polyethylene bags within fiber drums, with sizes ranging from 1kg to 25kg to accommodate varying production needs. Our global distribution network ensures reliable supply with multiple manufacturing sites and contingency planning to mitigate supply chain disruptions. Custom packaging options are available for specific customer requirements, including vacuum packaging for enhanced stability in humid climates.

Technical Support and Partnership Opportunities

Our technical team provides comprehensive support for formulation development, analytical method transfer, and regulatory documentation preparation. We offer assistance in optimizing manufacturing processes, conducting stability studies, and addressing specific technical challenges in product development. We welcome collaborative partnerships for developing novel delivery systems, exploring new therapeutic applications, and creating differentiated products that leverage the established efficacy of doxylamine succinate in innovative ways.

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FAQ

Q1. Can I get a free sample?

We can send you a samll free sample, and you only need to pay for the shipping cost.

Q2. What is the HyperChem payment term?

T/T in advance
LC at sight
DP at sight

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Q3. What is HyperChem shipment policy?

Our policy is to strive for the quickest shipment time possible.

For ready stock samples, they are usually shipped within 3 working days after payment received.
For non-ready stock, please contact HyperChem sales team to negotiate.

Q4. What is HyperChem shipment term?

By Express  
FedEx  UPS  DHL  EMS                               
Fast: 3-7 days around, high cost, door to door service

By Air                                        
Suitable for more than 50kg 
Fast: 3-7 days, hight cost, port to port, professional broker needed 

By Sea
Suitable for more than 500kg      
Fast: 7-45 days, low cost, port to port, professional broker needed 

We will always attempt to utilize the quickest and most affordable way for customers to receive orders. And follow -up with customers via email for all shipment details as well as updated track information until it arrives without damage.

Q5. What HyperChem will provide after shipment?

For sample orders: 
After shipment is done, an timely email including:

1. Track details (Fedex /TNT/DHL/EMS Track number)
2. Packaging photo
3. COA, MSDS, etc
4. Dispatch date & Estimated arriving time
5. Shipping invoice

For commercial orders
A full set of shipment documents as well as package photos can be provided in scan-copy and original, to help customers complete the customs clearance process.

Company Profile

Established in 2013, Hyper Chem has exclusive tie-ups with leading manufacturers, supplying raw materials produced in GMP and ISO 9002 certified facilities, and provides high-quality ingredients and raw materials to cater to the requirements of our diverse range of clients.

Among them, our key client industrial sectors around the global are:

Pharmaceuticals
Nutrition Ingredients/ Dietary supplements
Cosmetic Ingredients
Food Ingredients
Veterinary API
Agriculture fertilizer
Custom Synthesis lab supply

HyperChem provides to its wonderful and honorable clients comprehensive purchasing and distribution services which ensure that we are delivering the right generic, raw, or customized product, make sure that we are delivering it at the right time, ensure that it is delivered in the specified amount, and in the right kind of packaging to clients and customers of all types of industries irrespective of their size of operation.