High Quality Chemical API Sunitinib Malate
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Model NO.: 341031-54-7
Trademark: MESOCHEM
Transport Package: 25kg
Specification: GMP
Origin: China
HS Code: 2934999090
Model NO.: 341031-54-7
Trademark: MESOCHEM
Transport Package: 25kg
Specification: GMP
Origin: China
HS Code: 2934999090
Certificate  of  Analysis
Product Name: Sunitinib Malate
CAS No.: 341031-54-7
 
Batch No. HF170619 Quantity 7.5kgs
Mfg. Date Jun. 19, 2017 Package As required
Rep. Date Jun. 22, 2017 Exp. Date Jun. 18, 2019
Items Standards Results
Appearance An orange to yellow powder An orange powder
Identification By IR Complies
By HPLC Complies
Solubility Soluble in 0.1mol/L HCl solution, slightly soluble in water and DMF, insoluble methanol, ethanol, acetonitrile, acetone, THF and 0.1mol/L NaOH solution Complies
Loss on Drying ≤ 1.00% 0.19%
Heavy Metals ≤ 10ppm Complies
Residue on Ignition ≤ 0.50% 0.12%
Residual Solvent Acetone: ≤ 5000ppm 600ppm
DMF: ≤ 880ppm ND
Related Substances Impurity A: £ 0.40% 0.03%
Impurity B: £ 0.40% 0.04%
Impurity C: £0.15% 0.03%
Impurity E: £0.15% ND
Any other single impurity: ≤0.10% Complies
Total Impurities: ≤1.00% 0.25%
Assay
(HPLC basis on drying) 		98.0%~102.0% 99.85%
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.
Storage Preserve in tight,light-resistant containers in a cool place
Certificate  of  Analysis
Product Name: Sunitinib Malate
CAS No.: 341031-54-7
 
Batch No. HF170619 Quantity 7.5kgs
Mfg. Date Jun. 19, 2017 Package As required
Rep. Date Jun. 22, 2017 Exp. Date Jun. 18, 2019
Items Standards Results
Appearance An orange to yellow powder An orange powder
Identification By IR Complies
By HPLC Complies
Solubility Soluble in 0.1mol/L HCl solution, slightly soluble in water and DMF, insoluble methanol, ethanol, acetonitrile, acetone, THF and 0.1mol/L NaOH solution Complies
Loss on Drying ≤ 1.00% 0.19%
Heavy Metals ≤ 10ppm Complies
Residue on Ignition ≤ 0.50% 0.12%
Residual Solvent Acetone: ≤ 5000ppm 600ppm
DMF: ≤ 880ppm ND
Related Substances Impurity A: £ 0.40% 0.03%
Impurity B: £ 0.40% 0.04%
Impurity C: £0.15% 0.03%
Impurity E: £0.15% ND
Any other single impurity: ≤0.10% Complies
Total Impurities: ≤1.00% 0.25%
Assay
(HPLC basis on drying) 		98.0%~102.0% 99.85%
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.
Storage Preserve in tight,light-resistant containers in a cool place