MAROPITANT MAROPITANT CITRATE maropitant
1. ISO
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEM |
SPECIFICATIONS |
RESULTS |
Appearance |
White to pale yellow powder |
White powder |
Identification |
Citrates Identification:Positive reaction |
Positive reaction |
IR: Correspond with the reference standard spectrum |
Conformed |
|
Water |
2.0% ~ 3.5% |
2.7% |
Residue on ignition |
≤0.1% |
0.03% |
Heavy Metals |
≤10ppm |
<10ppm |
Particle Size |
D50 < 50um D90 <100um |
D50:17um D90:29um |
Related Substances |
WI-0489 ≤0.20% |
ND |
WI-0490 ≤0.20% |
ND |
|
WI-0491 ≤0.20% |
ND |
|
WI-0571 ≤0.20% |
ND |
|
Single Impurity ≤0.20% |
<LOQ (LOQ:0.05%) (Testing result :0.02%) |
|
Total Impurity ≤0.50% |
<LOQ |
|
Enantiomer WI-0534 ≤0.20% |
ND |
|
Residual Solvents |
Ethanol ≤ 5000ppm |
ND |
THF ≤ 720ppm |
ND |
|
IPA ≤ 5000ppm |
ND |
|
Toluene ≤890ppm |
ND |
|
N-heptane ≤5000ppm |
ND |
|
Acetone ≤ 5000ppm |
307ppm |
|
MTBE ≤ 5000ppm |
317ppm |
|
Methanol ≤ 3000ppm |
168ppm |
|
Ethyl acetate ≤ 5000ppm |
ND |
|
Assay |
98.0~102.0% (on anhydrous) |
100.4% |
Microbiological Items |
TAMC ≤ 1000CFU/g |
<10CFU/g |
TYMC ≤100 CFU/g |
<10CFU/g |
|
E.Coli : Not to be detected |
ND |
|
Conclusion: Conforms to the enterprise standard. |
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