(S)-2-((S)-(2-ethoxyphenoxy)(phenyl)methyl)-4-nitrosomorpholine
(S)-2-((S)-(2-ethoxyphenoxy)(phenyl)methyl)-4-nitrosomorpholine is useful for analysis of a pharmaceutical composition. Also disclosed herein are methods of determining the quality of pharmaceutical compositions, and dosage forms comprising a reduced level of (S)-2-((S)-(2-ethoxyphenoxy)(phenyl)methyl)-4-nitrosomorpholine. Therapeutic uses of the pharmaceutical compositions and dosage forms are also described herein.
1 . A dosage form comprising esreboxetine, or a pharmaceutically acceptable salt thereof, and less than 13 ppm of a compound represented by a formula.
2 . The dosage form of claim 1 , further comprising hydroxypropyl methylcellulose.
3 . The dosage form of claim 1 , further comprising directly compressible starch.
4 . The dosage form of claim 1 , further comprising microcrystalline cellulose.
5 . The dosage form of claim 1 , further comprising silicon dioxide.
6 . The dosage form of claim 1 , further comprising magnesium stearate.
7 . The dosage form of claim 1 , further comprising a film coating.
8 . The dosage form of claim 1 , further comprising hydroxypropyl methylcellulose and directly compressible starch.
9 . The dosage form of claim 1 , further comprising hydroxypropyl methylcellulose and microcrystalline cellulose.
10 . The dosage form of claim 1 , further comprising directly compressible starch and microcrystalline cellulose.
11 . The dosage form of claim 1 , further comprising hydroxypropyl methylcellulose, directly compressible starch and microcrystalline cellulose.
12 . The dosage form of claim 1 , comprising about 3% to about 6% esreboxetine, or a pharmaceutically acceptable salt thereof, by weight.
13 . The dosage form of claim 1 , further comprising about 35% to about 45% hydroxypropyl methylcellulose by weight.
14 . The dosage form of claim 1 , further comprising about 30% to about 35% directly compressible starch by weight.
15 . The dosage form of claim 1 , further comprising about 15% to about 25% microcrystalline cellulose by weight.
16 . The dosage form of claim 1 , further comprising about 0.1% to about 0.2% silicon dioxide by weight.
17 . The dosage form of claim 1 , further comprising about 0.7% to about 0.8% magnesium stearate by weight.
18 . The dosage form of claim 1 , further comprising about 5% of the film coating by weight.
19 . A dosage form comprising esreboxetine succinate and less than 13 ppm of a compound represented by a formula:
20 . The dosage form of claim 19 , further comprising starch.
21 . The dosage form of claim 19 , further comprising silicon dioxide.
22 . The dosage form of claim 19 , further comprising magnesium stearate.