Product Name : TERBUTALINE SULFATE
Molecular Formula : (C12H19NO3 )2H2SO4
Molecular Weight : 548.65
Synonyms : (1, 3- Benzendiol, 5-[2-[(1, 1- dimethylethyl amino]-1- hydroxyethyl]-, sulfate (2:1) (salt)
CAS No :23031-32-5
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | White to grey- white, crystalline powder. Odorless or has a faint odor of acetic acid. |
| 2 | Solubility | Soluble in water and in 0.1N hydrochloric acid; slightly soluble in methanol; insoluble in chloroform. |
| 3 | Identification – By IR – By HPLC |
The IR absorption spectrum of the test preparation
should exhibits maxima at the same wavelength as that
of a similar preparation of Terbutaline sulfate working
standard. The principal peak in the chromatogram obtained with test solution should correspond to the peak in the chromatogram obtained with the working standard. |
| 4 | Acidity (2%w/v solution in water) | Not more than 0.50 ml of 0.02N sodium hydroxide is required (0.3% as acetic acid) |
| 5 | Loss in drying (%w/w) (at 105°C for 3 hrs) | Not more than 0.5 |
| 6 | Residue on ignition (%w/w) | Not more than 0.2 |
| 7 | Heavy Metal | 0.0025% |
| 8 | Chromatographic Purity (By HPLC) Total impurities |
Not more than 1.0 |
| 9 | Assay (By HPLC) (%w/w ODB) | Between 98 and 101.0 |