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.

Product

Tasimelteon

609799-22-6

Analysis Standard

Enterprise Standard

20160902

Date of Manufacture

20160902

225 g

Date of Retest

20170901

20160905

Testing Items

Specifications

Result

Appearance

White to off-white crystalline powder

Complies

Identification

HPLC: Positive

Complies

IR: Positive

Complies

Loss on drying

≤0.5%

0.01%

Residue on Ignition

≤0.1%

0.01%

Related Substances (HPLC)

Impurity A≤0.1%

N/D

Impurity B≤0.1%

N/D

Impurity C≤0.1%

0.04%

Any other single impurity≤0.1%

N/D

Total impurities≤0.5%

0.04%

Chiral Purity (HPLC)

≥99.9%

100%

Heavy Metals

≤10ppm

Complies

Residual solvents

Ethanol≤5000ppm

300 ppm

Tetrahydrofuran≤720ppm

N/D

Ethyl acetate≤5000ppm

600 ppm

Toluene≤890ppm

31 ppm

Assay

98.0 – 102.0% ( on anhydrous basis)

100.2%

Conclusion

Complies with the Enterprise Standard.