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Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep

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Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep

Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep
Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep

Large Image :  Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep

Product Details:
Place of Origin: CHINA
Brand Name: TINGYI
Certification: GMP , ISO 9001:2008
Model Number: 609799-22-6
Payment & Shipping Terms:
Minimum Order Quantity: Negotiation
Price: Contact Us
Packaging Details: Stealth And Discreet Packaging
Delivery Time: Within 7 Working Days
Payment Terms: Bank Transfer - Bitcoin - Western Union - MoneyGram
Supply Ability: 100 KG/Month
Detailed Product Description
Product Name: Tasimelteon Analysis Standard: Enterprise Standard
Appearance: White To Off-white Crystalline Powder Alias: Hetlioz
CAS: 609799-22-6 Shipping Method: EMS, HKEMS, FEDEX, DHL, UPS, Aramex, ETC
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Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For good Sleep

 

 

Abstract

 

Tasimelteon was developed for the treatment of insomnia and other sleep disorders. A phase II trial on circadian rhythm sleep disorders was concluded in March 2005. A phase III insomnia trial was conducted in 2006. A second phase III trial on insomnia, this time concerning primary insomnia, was completed in June 2008. In 2010, the FDA granted orphan drug status to tasimelteon, then regarded as an investigational medication, for use in totally blind adults with N24HSWD.

On completion of Phase III trials, interpretations of the clinical trials by the research team concluded that the drug may have therapeutic potential for transient insomnia in circadian rhythm sleep disorders. A year-long (2011-2012) study at Harvard tested the use of tasimelteon in blind subjects with non-24-hour sleep-wake disorder. The drug has not been tested in children nor in any non-blind people.

 

 

Specification

 
Product Tasimelteon CAS NO. 609799-22-6
Analysis Standard Enterprise Standard Batch No. 20170102
Testing Items Specifications Result  
Appearance White to off-white crystalline powder Complies  
Identification HPLC: Positive
IR: Positive
Complies
Complies
 
Loss on drying ≤0.5% 0.01%  
Residue on Ignition ≤0.1% 0.01%  
Related Substances (HPLC) Impurity A≤0.1%
Impurity B≤0.1%
Impurity C≤0.1%
Any other single impurity≤0.1%
Total impurities≤0.5%
N/D
N/D
0.04%
N/D
0.04%
 
Chiral Purity (HPLC) ≥99.9% 100%  
Heavy Metals ≤10ppm Complies  
Residual solvents Ethanol≤5000ppm
Tetrahydrofuran≤720ppm
Ethyl acetate≤5000ppm
Toluene≤890ppm
300 ppm
N/D
600 ppm
31 ppm
 
Assay 98.0 - 102.0% ( on anhydrous basis) 100.2%  
Conclusion Complies with the Enterprise Standard.    

 

 

Tasimelteon is a drug approved by the U.S. Food and Drug Administration (FDA)in January 2014 for the treatment of non-24-hour sleep-wake disorder (also called Non-24, N24 and N24HSWD).In June 2014, the European Medicines Agency accepted an EU filing application for tasimelteon and in July 2015, the drug was approved in Europe for the treatment of non-24-hour sleep-wake rhythm disorder in totally blind adults,but not in the rarer case of non-24 in sighted people.

Tasimelteon is a selective agonist for the melatonin receptors MT1 and MT2, similar to other members of the melatonin receptor agonist class of which ramelteon (2005) and agomelatine (2009) were the first approved.As a treatment for N24HSWD, as with melatonin or other melatonin derivatives, the patient may experience improved sleep timing while taking the drug. Reversion to baseline sleep performance occurs within a month of discontinuation.

 

 

Important safety information

 

Tasimelteon may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use tasimelteon with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking tasimelteon; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


Tasimelteon may take several weeks or months to work. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


Use tasimelteon with caution in the ELDERLY; they may be more sensitive to its effects.


Tasimelteon should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

 

Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep 0


PREGNANCY and BREAST-FEEDING

 

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking tasimelteon while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you take tasimelteon, check with your doctor. Discuss any possible risks to your baby.

 

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Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For Good Sleep 1
 

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