Meclizine Hydrochloride Meclozine Hcl USP Meclizine dihydrochloride Customer requested
Specification: USP or Customer Request Packing: 25kg/drum
Items |
Specification |
Results |
Characters |
A white or slightly yellowish crystalline powder |
Slightly yellowish |
Identification |
A: The infrared absorption spectrum of sample corresponds to that of Meclizine Hydrochloride RS. |
Meets |
B: Responds to the test for chloride. |
Meets |
|
Water |
≤5.0% |
4.4% |
Residue on ignition |
≤0.1% |
0.06% |
Organic impurities (Procedure 2) |
Impurity -1 ≤0.10% |
Not detected |
Impurity -2 ≤0.10% |
Not detected |
|
Impurity -3 ≤0.15% |
<0.03% |
|
Impurity -4 ≤0.10% |
<0.03% |
|
Impurity -5 ≤0.15% |
0.04% |
|
Impurity -6 ≤0.10% |
Not detected |
|
Max. Single unknown impurity ≤0.10% |
<0.03% |
|
Total impurities ≤1.0% |
0.15% |
|
Residual solvents |
Toluene ≤ 890 ppm |
10ppm |
Chloroform ≤50 ppm |
<16ppm (Detection limit) |
|
Ethanol ≤5000ppm |
1488 ppm |
|
Assay |
97.0%~102.0% (on the anhydrous basis) |
99.5% |
Conclusion: The above product meets USP and Customer’s Standard |
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