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Molecular Formula

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Molecular Weight

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Description: White to Light cream-colored, crystalline powder. Is affected by light.
Solubility: Freely soluble in water; soluble in alcohol; sparingly soluble or soluble in ethanol (96%), practically insoluble in ether & methylene chloride
Identification (By IR): IR spectra of the sample should be concomitant with IR spectra of the corresponding standard
Identification (By chemical test): A pale yellow precipitate should be form
Identification (by Assay): The retention time of the major peak of the sample solution should correspond to that of the standard solution as obtain in the assay
Identification(By Melting point): 103°C - 115°C
Identification (Mercury): The spot should disappear
Identification (Sulfate): A white precipitate should form
Identification (Sodium): A dense white precipitate should form.
Appearance of solution: Solution should not be more opalescent than reference suspension II and not more intensely coloured than reference solution B6
pH: 6.0 - 8.0
Assay (By HPLC, on dried basis): 97.0% - 102.0%
Assay(By titration, dried substance): 97.0% - 101.0%
Mercury/ Inorganic mercury compounds: NMT 0.70%
Organic impurities : Thiosalicylic acid: NMT 0.10%
Organic impurities : Thimerosal related compound A: NMT 0.10%
Organic impurities : Any other individual impurity (Unspecified impurity): NMT 0.10%
Organic impurities : Total impurities: NMT 1.0%
Loss on drying: NMT 0.5 %
Total aerobic microbial count: NMT 100 CFU/gm
Total Yeast and mold count: NMT 100 CFU/gm
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