Supply Atropine Sulfate Monohydrate with GMP

Details:

CERTIFICATE OF ANALYSIS

Product: Atropine Sulphate                     Batch No: 20130502

Manufacturing Date: 2013-05-13                Expiry Date: 2015-05-12  

Items                     Specifications                 Results

Appearance:     White or almost white crystalline powder     Complies     

                        or colourless crystals   

Solubility:               Very soluble in water,               Complies  

                  freely soluble in ethaol(96 per cent)

Identification:

  Optical rotation & Infrared absorption & Chemical reaction             Complies  

  Chemical reaction &The reaction of sulfates & The reaction of alkaloids  Positive

PH:                          4.5~6.2                      5.7

Optical Rotation:            -0.50⁰~+0.05⁰                             -0.005⁰

Impurity:

             A≤0.2% & B≤0.2% & C≤0.2% & D≤0.2%              Complies

             E≤0.3% & F≤0.2% & G≤0.2% & H≤0.3%              Complies

             Unspecified impurity≤0.1%                          Not detected

             Total≤0.5%                                        0.09%

Water:                         2.0~4.0%                  1.7%

Sulphated ash:                   ≤0.1%                   0.04%

Assay(aNhydrous substance):99.0~101.0%                  99.5%

Residue solvent(Acetone):     ≤0.25%                  Not detected

Conclusion:It Complies with EP7.0

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