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10 Gram |
Negotiable |
Fexofenadine hcl Fexofenadine hydrochloride cas 153439-40-8
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Product Name:Fexofenadine Hydrochloride
CAS No:83799-24-0
Assay:98.0%~102.0%
PARAMETERS |
LIMITS |
RESULTS |
|
Description |
whiter crystalline powder |
whiter crystalline powder |
|
Solubility |
soluble in methanol and in dilute alkali solutions |
Complies |
|
Identification |
IR |
To Comply |
Complies |
HPLC |
To Comply |
Complies |
|
Melting range |
191 to 198 Degree |
192 to 196 Degree |
|
Loss on drying |
Not more than 1.0% w/w |
0.07% w/w |
|
Chlorides |
6.46 to 6.66% w/w |
6.57% w/w |
|
Residue on ignition |
Not more than 0.1% |
0.04% |
|
Heavy metals |
Not more than 20ppm |
Complies |
|
Related substances(HPLC) |
Not more than 0.50% |
0.21% |
|
Total impurity Assay(HPLC) |
Not more than 1.00% |
0.54% |
|
Residual solvents (GC) |
98.0 to 102.0% w/w |
98.71% w/w |
|
Isopropyl Alcohol |
Not more than 5000ppm |
3727.50ppm |
|
Ethyl Acetate |
Not more than 5000ppm |
764.79ppm |
|
Particle Size (Malvern) |
90% less than 100 |
Complies |
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