|
PHARMA INTERMEDIATES SPECIFICATION
| ALENDRONIC ACID |
| Specification |
For : Alendronic Acid
 |
| CAS No. |
66376-36-1 |
| CAS NAME |
(4-Amino-1-hydroxybutylidene)bisphosphonic acid |
| ADDITIONAL NAME |
ð-hydroxy-ð-aminobutylidenediphosphonic
acid |
| MOLECULAR WT. |
249.10 |
| CHEMICAL COMPOSITION |
C4H13NO7P2 |
| Test |
Specification |
| DESCRIPTION |
White Crystalline Powder |
| IDENTIFICATION |
A. I. R. TEST |
| HEAVY METALS |
LIMIT : Max .20PPM |
| LOSS OF DRYING (By Kf) |
1% W/W |
| 4-AMINOBUTANOIC ACID (by
TLC) |
LIMIT MAX.0.5% |
| PHOSPHITE |
LIMIT MAX.0.5% |
| ASSAY (TITRATION) |
LIMIT: 98% to 102%
|
| AMINO BUTYRIC ACID OR 4 - AMINOBUTANOIC ACID |
| Specification |
For : 4 - Amino butyric Acid OR 4 -
Aminobutanoic Acid |
| CAS. NO. |
[56-12-2] |
| Molecular Formula |
C4H9NO2 |
| Molecular Weight |
103.12 |
| Test |
Specification |
| Description |
White Crystalline Powder |
| Identification |
Chemical Test |
| Clarity of Solution |
It should be Clear |
| pH |
Limit : 6.5 - 7.5 |
| Heavy Metals |
Limit: Max. 10 PPM |
| Chloride |
Limit : Max.40 PPM |
| Sulphate |
Limit : Max.50 PPM |
| Arsenic |
Limit : Max. 1PPM |
| Ca2+ |
No Opalescence |
| Melting Point |
Limit : 197° C - 204° C |
| Loss of Drying |
Limit : Max. 0.5% |
| Residue on Ignition |
Limit : Max.0.1% |
| Assay |
Limit : Min.99% |
|
