|
Items of Test |
Limits of Test |
Results of Test |
|
1.Appearance |
Orange yellow crystalline powder |
Meets |
|
2.Identification |
Positive |
Meets |
|
3.Acidity or Alkalinity |
check the color of the test solution after adding the respective solutions |
Meets |
|
4.Lumiflavin |
Absorbance of the filtrate at 440nm does not exceed 0.025 (USP);not more intense than BY6(EP/BP) |
0.008 Meets |
|
5.Absorbance |
0.31-0.33 A373nm/A267nm 0.36-0.39 A444nm/A267nm |
0.32 0.38 |
|
6.Particla Size |
100% passes through 60 mesh sieve |
Meets |
|
7.Specific Rotation |
between-115º and -135º (EP/BP/USP) |
-121º(USP) -1300(BP/EP) |
|
8.Loss on Drying |
≤1.5% |
0.4% |
|
9.Heavy Metals |
<10ppm |
Meets |
|
10.Residue on Ignition |
≤0.3% (USP) ≤0.1%(EP/BP) |
0.1% |
|
11.Residual Solvents |
Method IV <467> (USP) |
Meets |
|
12.Assay(ondried basis) |
98.0%-102.0% (USP) 97.0%-103.0% (EP/BP) |
98.8%(USP) 99.7%(EP/BP) |
|
CONCLUSION: The product with this batch number meets all requirements of the following valid compendia when tested accordingly: EP5+BP2008+ USP33. |
||
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Min.Order / FOB Price:Get Latest Price
| 1 Metric Ton |
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Keywords
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Quick Details
- Appearance:crystal, powder
- Application:Pharmaceutical intermediates
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Details:
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