TERBUTALINE SULFATE

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
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