PRODUCT INFORMATION
| 1 |
Name of the product | Bromhexine
Hydrochloride | |
2 |
Drug master file | Available |
| 3 | Specifications | As
per British Pharmacoepia /
European Pharmacoepia | |
4 | Capacity
of the product | 5.0
m.t. per month | |
5 |
Batch size/Batch cycle | Batch
size : 300/ 500 kgs
Batch cycle : 144 hours | |
6 | Lead
time for supply of product
| Prompt
(ex-stock) | | 7 |
Certificate of Suitability
issued
by EDQM bearing registration No. |
RO-CEP 2003-021-Rev 01 |
TECHNICAL DATA OF BROMHEXINE HYDROCHLORIDE B. P. / Eu. Ph.
MOLECULAR
FORMULAE : C14 H20 Br2 N2 HCL, MOL.
WT. : 412.6
CAS NO.: 611-75-6 MERCK
INDEX NO.: 1412 EINECS NO.
: 210-280-8 CHEMICAL NAME
: 2-amino-3,5-dibromobenzyl (cyclohexyl)
methylmmonium
chloride.
C
40.76%, H 5.13% Br 38.73%, N 6.79% Cl 8.59%.
It
contains not less than 98.5 percent and not more than 101.5 percent of C14 H20
Br2 N2, HCL, calculated with reference to the dried substance. CHARACTERISTICS
: A white or almost white, crystalline powder, odourless or almost odourless. SOLUBILITY
: Practically insoluble in water; sparingly soluble in ethanol (96%) and in
methanol; slightly soluble in chloroform. STORAGE
: Bromhexine Hydrochloride should be protected from light. THERAPEUTIC
CATEGORY : Expectorant; mucolytic | 
