|
S.No. |
TEST |
SPECIFICATION |
|
01. |
Description
|
A white to almost white crystalline powder. |
| 02. |
Solubility |
Freely soluble in water, soluble in
Methanol |
| 03. |
Identification
b) Chloride test |
a) IR: The Infra Red
absorption spectrum of the finely ground sample in KBr dispersion
compressed into a disc should exhibit maxima only at the same wavelengths
as
that of a similar preparation of Bambuterol Hydrochloride working
standard.
Should comply the requirements of the test.
|
| 04. |
Acidity or Alkalinity |
Should
comply the requirements of the test. |
| 05. |
Optical rotation |
Between -0.10o to +0.10o |
| 06. |
Related substances
By HPLC |
Single
maximum impurity NMT: 0.2%.
Total impurities NMT: 0.6%.
|
| 07. |
Water
content by KF |
should not be more than 0.5% w/w
|
