Novabay ove rep TECHNICAL DATASHEET 4 Sodium Bicarbonate PHARMACEUTICAL GRADE - FINE “a — CHEMICAL INFORMATION SOLUBILITY m NaHCO3 = Freely soluble in water, practically = Molecular weight : 84 g/mol insoluble in ethanol 96 Natrii hydrogenocarbonas 95% aqueous solution: pH < 8.4 (Sodium bicar @ Limpid and colorless solution MN’ CAS : 144-55-8 MN EINECS : 20 IDENTIFICATION m In compliance with European, ASPECT Japanese and British pharmacopoelas (latest editions in force) = In compliance with USP, but Na2CO3 content for Hemodialysis. = White fine crystalline powder CHEMICAL CHARACTERISTICS Specification ‘Sodium bicarbonate (NaHCO3) ‘Sodium carbonate (Na,CO,) in % Carbonate (CO,) in 6 Loss on drying (HO) in % Sulfates (SO,"") in mg/kg Iron (Fe) in me/kg. Calcium (Ca) in mg/kg ‘Ammonium (NH,) in mg/kg. ‘Magnesium (Mg) in mg/kg ‘Alurninumn (Al) in ma/kg Arsenic (As) in mg/kg Heavy metals in mg/kg. Insoluble substances ‘Copper (Cu) in ma/kg. Limit of organics in 9% There isno residual solvent as Novabay’s manufacturing proces is free from solvent. Microbiological characteristics can be provided on demand. “Specification” value is the most restrictive between USP, European, Japanese and British pharmacopoeia. Values in “USP” column apply for hemodialysis grade only *Na2C03 = C08 x (106/60) /CO3< 0.23 % > Na2CO3 0.40% tnovabay ove group TECHNICAL DATASHEET Sodium Bicarbonate PHARMACEUTICAL GRADE - FINE PARTICLE SIZE DISTRIBUTION Cumulative fraction retained > 250 um in % Cumulative fraction retained > 50 um in % PACKAGING = Big Bags 1000kg (bulk bags in PE, with an inner liner in PE) 1m 25kg bags / pallet of 1050kg or 1200kg (plastics bags) CP9 pallets= 114x114 om (heat treatment) PE interlayer on the floor of the pallet CERTIFICATE OF ANALYSIS On request STORAGE CONDITIONS m The stacking of pallets is not recommended = Storage in dry and cool place (protected from the weather) 1m Re-test date: 24 months MAIN USES m Excipients = Cosmetics = Hemodialysis 20 Tembusu Avenue Singapore 627536 Phone: #65 69110331 wwwnovacap.asia