- Min.Order :1 Kilogram
- Purity: 98% HPLC
- Payment Terms : L/C,D/A,D/P,T/T,
Keywords
Dutasteride Dutasteride powder Dutasteride usp
Quick Details
- Appearance:WHITE POWDER
- Application:active pharmaceutical ingredient
- PackAge:as request
- ProductionCapacity:|Metric Ton|Day
- Storage:in cool
- Transportation:as request
Superiority:
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
Micro powder / Crude powder can be made to order
EP/USP both ok
Details:
|
ITEMS |
SPECIFICATION |
RESULTS |
|
Description |
White or pale yellow powder |
White powder |
|
Identification |
A:IR B: The retention time of the major peak of the Sample solution corresponds to that the Standard solution, as obtained in the Assay. |
Complies |
|
Optical Rotation |
+15.0°to +25.0° |
+22.1° |
|
Water Determination |
NMT0.50% |
0.28% |
|
Organic Impurities, Procedure 1
|
Dutasteride acida(RRT0.10)≤0.2% |
N.D |
|
Dutasteride dimethylamideb(RRT0.11)≤0.2% |
0.01% |
|
|
Dutasteride methylesterC (RRT0.28)≤0.15% |
0.01% |
|
|
Dutasteride ethyl esterD (RRT0.39) ≤0.2% |
N.D |
|
|
Dutasteride 17a-5-enee(RRT0.90)≤0.2% |
0.02% |
|
|
Dutasteride 17a-epimer(RRT0.93)≤0.3% |
0.03% |
|
|
Chlorodutasteridef(RRT1.15)≤0.4% |
0.03% |
|
|
Dutasteride 5-eneg (RRT1.20) ≤0.3% |
N.D |
|
|
Any other individual impurity ≤0.1% |
0.07% |
|
|
Organic Impurities Procedure 2
|
Dihydrodutasteridea(RRT1.19)≤0.15% |
0.01% |
|
Dutasteride a-dimer(RRT3.7)≤0.3% |
N.D |
|
|
Dutasteride β-dimer(RRT4.3)≤0.5% |
N.D |
|
|
Any other individual impurity≤0.1% |
0.01% |
|
|
Total impuritiesb ≤2.0% |
0.22% |
|
|
Assay(based on drying) |
NLT 97.0% and NMT 102.0% of dutasteride |
99.9% |
|
Residue on ignition |
Max.0.1% |
Complies |
|
Residual Solvents (GC):
|
Acetonitrile N.m.t.3000ppm |
N.D |
|
Ethyl acetate N.m.t.2000ppm |
603PPM |
|
|
Dioxane N.m.t.1000ppm |
N.D |
|
|
n-Heptane N.m.t.5000ppm |
N.D |
|
|
Pyridine N.m.t.2000ppm |
N.D |
|
|
Toluene N.m.t.2000ppm |
N.D |
|
|
Conclusion: The product complies with USP40 Storage condition: Room temperature ,in a closed container. |
||
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