Urinary System

Oxybutynin Hydrochloride

C22H32ClNO3 Molecular weight: 393,95 Code : 15800 Description : White crystalline powder. Melting point : 124,0 – 129,0 °C Colour of solution : Max. BY5 Sulphated ashes : Max. 0,1 % Assay : 99,0 - 102,0 % Impurities (HPLC) : Impurity A : Max. 1,5 % Sum of other impurities : Max. 0,5 % References :

Oxybutynin Base

C22H31NO3 Molecular weight: 357,49 Code : 10015 Description : White crystalline powder. Melting point : 56,0 – 58,0 °C Sulphated ashes : Max. 0,1 % Assay : 99,0 - 101,0 % Impurities (HPLC) : Phenylcyclohexylglycolic acid (PCGA) : Max. 0,1 % Each other impurity : Max. 0,1 % Sum of all impurities : Max. 0,5 % Registration : USDMF, EDMF

Metolazone

C16H16ClN3O3S Molecular weight: 365,84 Code : 14905 Description : White to off-white crystalline powder. Sulphated ashes : Max. 0,1 % Assay : 97,0 - 102,0 % Impurities (HPLC) : A. Impurity “unreduced” : Max. 0,5 % B. Impurity “Benzamide” : Max. 0,5 % C. Impurity “Phenyl” : Max. 0,5 % D. Impurity “Meta” : Max. 0,5 % E. Impurity “Para” : Max. 0,5 % Sum impurities A, B and C : Max. 1,0 %

Methenamine Hippurate

C15H21N5O3 Molecular weight: 319,36 Code : 14880 Description : White crystalline powder. pH : 4,0 – 4,5 Sulphated ashes : Max. 0,10 % Assay : 95,5 –102,0 % Hippuric acid : 54,0 – 58,0 % References : USP Packaging :

Bethanechol Chloride

C7H17ClN2O2 Molecular weight: 196,68 Code : 10207 pH : 5,5 – 6,5 Assay : 98,0 – 101,5 % 17,7 – 18,3 % Cl Impurities (HPLC) : 2-Hydroxypropyltrimethylammonium chloride : Max. 0,3 % Ammonium chloride : Max. 0.3 % Trimethylammonium chloride : Max. 0.3 % Any other impurity : Max. 0.1 % Total of impurities : Max. 0.5 % References : USP Packaging :