Levothyroxine sodium

【Product Name】:Levothyroxine Sodium

【CAS NO.】:25416-65-3

【Molecular Weight】:798.85

【Formula】:C15H10I4NNaO4, xH2O

【Quality Standards】: USP,EP

【Package】:100g /500g/1Kg per bag


Levothyroxine sodium

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Note: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement and its liability is at buyer’s risk.

【Appearance】

Almost white or slightly brownish-yellow, fine, slightly hygroscopic, crystalline powder.

【Identification】

IR;HPLC 

【Solubility】

Very slightly soluble in water, slightly soluble in ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides.

【Appearance of solution】

Freshly prepared solution S is not more intensely coloured than reference solution BY3.

【Appearance of solution】

Solution S is clear and not more intensely coloured than reference solution B7or BY7.

【Specific optical rotation】

+16°~+ 20° 

【Related substances】

Liothyronine≤1.0% ;

β-Hydroxy-T4a≤0.15% ;

T4-Hydroxyacetic acidb≤0.15% ;

N-Formyl-T4c and T4-acetamided≤0.15% ;

N-Acetyl-T4e:≤0.2% ;

T4-Acetic acidf ≤0.30% ;

T4-Aldehydeg≤0.15% ;

T4-Benzoic acidh≤0.15%; 

Individual unspecified impurities:≤0.10% ;

Total Impurity≤2.0%  

【Water】

6.0%~12.0%  

【Assay】

97% ~103.0% 

【Usage】

It can be used for hormone replacement therapy of hypothyroidism

【Storage】

Preserve in tight containers, protected from light. Store as stated in the labeling instructions.








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