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Certificate of Analysis
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Product name: |
Sulfasalazine |
Batch No.: |
20210120 |
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Mfg. Date: |
Jan.20,2021 |
Exp. Date: |
Jan.19,2025 |
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Report Date: |
Jan.21,2021 |
Quantity: |
1000kgs |
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Execute standard：USP40 |
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NO. |
Item |
Specification |
Result |
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1． |
Appearance |
Bright yellow or brownish-yellow, Odorless,fine powder |
Confirm |
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2． |
Identification |
Conform With monograph A.B |
Confirm |
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3． |
Solubility |
Soluble in aqueous solutions of alkali hydroxides;very slightly soluble in alcohol;practically insoluble in water,in ether,in chloform,and in benzene |
Confirm |
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4． |
Chromatographic purity |
Single impurity NMT2.0% |
Confirm |
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Total impurity NMT4.0% |
Confirm |
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5． |
Residual solvents |
Pyridine NMT200ppm |
No detected
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Toluene NMT890ppm |
No detected
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DMF NMT880ppm |
No detected
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6． |
Mesh number |
All through 80 |
Confirm |
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7． |
Bulk density |
--- |
0.38g/cc |
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8． |
Tapped density |
--- |
0.63g/cc |
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9． |
Melting point |
248-253℃ |
250.0-252.5℃ |
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10． |
Chloride |
NMT 0.014% |
Confirm |
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11. |
Sulphate |
NMT 0.04% |
Confirm |
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12. |
Heavy metals |
NMT 0.002% |
Confirm |
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13. |
Loss on drying |
NMT 1.0% |
0.51% |
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14. |
Residue on ignition |
NMT 0.5% |
0.12% |
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15. |
Assay |
97.0—101.5% |
99.12% |
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Conclusion: |
Comply with specification |
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