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Allopurinol Allopurinol from Sinoway USP37 Allopurinol
Sinoway's advantages:
1)ISO 9001:2008 certificated company
2)27 years in pharmaceutical industry
3)Good quality,competitive price and professional service
4)China office of Fischer Chemicals AG (Switzerland)
Product's advantages:
1.Particle size:90% pass through 250 mesh
2.Total bacteria:NMT 1000cfu/g
3.Single Impurity : NMT 0.2
Product Information
Product Name |
Allopurinol |
Pharmaceutical Standard |
USP35 |
Batch No. |
20150214 |
||
Batch Quantity |
1000KGS |
Net Weight |
25kg/drum |
Manufacture Date |
Feb,14,2015 |
Expiry Date |
Feb,13,2018 |
Analysis Date |
Feb,15,2015 |
Report Date |
Feb,16,2015 |
Test Items |
Specifications & Requirements |
Results |
|
Appearance |
White or almost white powder |
Complies |
|
Appearance of solution |
A 5%Solution in 1 M sodium hydroxide is clear & not More intensely colored than reference solution Y6 or GY6 |
Complies |
|
Identification |
A. The ratio of absorbance measured at the minimum at 231nm to that measured at the maximum at 250nm is 0.52~0.62 |
0.59 |
|
B. Conform with IR spectrum |
Complies |
||
C. Meets the requirements |
Complies |
||
D. The principal spot in the test solution is similar in position and size to that in the reference solution |
Complies |
||
Related Substances (%)
|
Impurity A NMT 0.2 |
Not detected |
|
Impurity B NMT 0.1 |
0.03 |
||
Impurity C NMT 0.1 |
0.03 |
||
Unspecified impurity* NMT 0.10 |
0.03 |
||
Total impurities other than A, B and C NMT 0.3 |
0.09 |
||
Impurity D NMT 0.1 |
Not detected |
||
Impurity E NMT 0.1 |
Not detected |
||
Impurity F** NMT 2.5 (ppm) |
Not detected |
||
Heavy metals (ppm) |
NMT 10 |
Less than 10 |
|
Loss on drying (%) |
NMT 0.5 |
0.04 |
|
Sulphated Ash (%) |
NMT 0.1 |
0.03 |
|
Residual Formamide |
NMT 220(ppm) |
Not detected |
|
Assay (HPLC)(%) |
98.0~102.0 |
99.88 |
|
Conclusion |
This inspect result complies with USP35 |
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