Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For good Sleep
Superiority
Zhongshan Latterson Biotechnology Co., Ltd., is a comprehensive pharmaceutical enterprise, which specialized in bio-pharmaceutical technology over 7 years. The company is located in Zhongshan City, Guangdong Province , China.
Our factory covers an area of 33500 square meters, with clean environment and nice layout. There are several large or medium workshops and QA and research center with advanced equipment. At present, our main products are Anabolic Steroid series, Peptide series, Local Anesthetic series. Our products reach the advanced standard of domestic market, many of which reach the international standard, certificates contain: KOSHER , ISO 9001:2008 , GMP , SGS.
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.
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.
Our service
1.100% reshipment policy is our business basic.100% reshipment immediately if your parcel stays Customs for 4 days and doesn’t get updated.
2.Total refund for 15 days of dissatisfaction with quality.
3.We can provide free samples.
4.We have a special packing ,It can be easily passed through the customs.It will be more safe.
5.Our company have a long term cooperate with DHL.EMS.Fedex and so on .It can be sent to your hand more quickly. Parcel photo should be offered within 12hours after receiving your steroid payment.
6.If you have a chance to come to China. I can show you our lab.
7.Our company has WU, MG, TT, and Bitcoin payment ways in advance.You can pay 95% for the peptides cost at first for order, the rest can offer us in your next order;
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