PRODUCT INFORMATION
| 1 |
Name of the product |
Timolol
Maleate | |
| | 2 |
Drug master file |
Available | |
3 | Specifications |
As
per british pharmacoepia / U. S. Pharmacoepia / European Pharmacoepia |
| 4 | Capacity
of the product |
100
kgs per month | |
5 |
Batch size/batch cycle |
Batch
size : 10 / 25 kgs
Batch cycle : 18 days
| |
6
| Lead
time for supply of product
Certificate of Suitability issued
by EDQM bearing registration No. |
| Prompt
|
TECHNICAL
DATA OF TIMOLOL MALEATE B. P./Eu. pH./U. S. P.
MOLECULAR FORMULAE : C13H24N4O3S.C4H4O4
MOL. WT. : 432.5
CAS NO.: 26921-17-5
MERCK INDEX NO.: 9585 EINECS
NO. : 248-111-5 CHEMICAL
NAME : (S)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3- yl)
oxy]-2-propanol maleate (1:1)
It contains not less than 98.0 percent
and not more than 101.0 percent of C13 H24 N4O3S,C4H4O4, calculated with reference
to the dried substance.
CHARACTERISTICS
: A white or almost white powder, odour or almost odourless. SOLUBILITY
: Soluble in water, ethanol (96%) and in chloroform; practically insoluble
in ether. Stable in solution upto pH 12 STORAGE
: Timolol Maleate should be stored in a tightly sealed container. THERAPEUTIC
CATEGORY : Beta-adrenoceptor antagonist; anti-glaucoma agent | 
