PRODUCT INFORMATION
| 1 |
Name of the product | Ambroxol
Hydrochloride | |
2 |
Drug master file | Available |
| 3 | Specifications | As
per British Pharmacoepia /
European Pharmacoepia | |
4 | Capacity
of the product | 3.0
m.t. per month | |
5 |
Batch size/batch cycle | Batch
size : 200/ 500 kgs
Batch cycle : 160 hours
|
| 6 | Lead
time for supply of product
| Within
a week upon receipt
of order confirmation. | 7 | Certificate
of Suitability issued
by EDQM bearing registration No.
| RO-CEP
2004-240-Rev 00 |
TECHNICAL
DATA OF AMBROXOL HYDROCHLORIDE B. P. / Eu. Ph.
MOLECULAR FORMULAE : C13 H18 Br2
N2O HCL, MOL. WT.
: 414.6
CAS NO.: 23828-92-4 MERCK
INDEX NO.: 401 EINECS NO. : 248-111-5
CHEMICAL NAME : trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride.
C 37.66%, H 4.62% Br 38.55%, N 6.76% O 3.86% Cl 8.55%.
It
contains not less than 99.0 percent and not more than 101.0 percent of C13 H18
Br2 N2 O. HCL, calculated with reference to the dried substance
CHARACTERISTICS
: A white or almost white, crystalline powder, odourless or almost odourless. SOLUBILITY
: Soluble in N,N-dimethylformamide, soluble in methanol , slightly soluble
in ethanol and water, practically insoluble in chloroform and benzene. STORAGE
: Ambroxol Hydrochloride should be protected from light. THERAPEUTIC
CATEGORY : Expectorant; enhanced mucolytic. crystalline powder, characteristic
odour
| 
