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Lactulose Solution SPECIFICATION EP
S.C.M. Società Chimica Mugello S.r.l. a socio unico Via E. Mattei, 26 50039 Vicchio (FI) / Italia T +39 055-843901 – F +39 055-844730 Registro Imprese Firenze 01423760485 REA: FI-268661 Cap. Soc. euro 1.820.000,00 i.v. Cod. Fisc. 01423760485 P. Iva 13145910157 Lactulose Solution SPECIFICATION EP Revision date: 05.03.2015 ................................................................................................................................................................................................................................................................. Tests Limits or Requirements Characters Clear, viscous liquid, colourless or pale brownish-yellow Identification Identification tests B, C, D: positive Appearance of solution Clear, not more intensely coloured than reference solution BY5 pH 3.0 to 7.0 Lactulose assay (HPLC) ≥ 62.0 % w/v 95.0 to 105.0 % of the declared content Galactose corresponding to lactulose Not more than 15.0 % Lactose corresponding to lactulose Not more than 10.0 % Epilactose corresponding to lactulose Not more than 10.0 % Tagatose corresponding to lactulose Not more than 4.0 % Fructose corresponding to lactulose Not more than 1.0 % 3-Deoxy-glyceropentulose corresponding to lactulose Not more than 4.0 % Unknown impurity G corresponding to lactulose Not more than 1.5 % Unknown impurity H corresponding to lactulose Not more than 1.5 % Single unspecified impurity corresponding to lactulose Sum of impurities eluting after impurity H corresponding to lactulose Not more than 0.5 % Not more than 1.3 % Total impurities excluding galactose and lactose corresponding to lactulose Not more than 12.0 % Sulphites Not more than 30 ppm Lead Not more than 0.5 ppm Sulphated ash Not more than 0.2 % referred to Lactulose Microbial contamination Total aerobic microbial count not more than 102 CFU/g Total combined yeasts/moulds count not more than 101 CFU/g Absence of Escherichia coli/g ................................................................................................................................................................................................................................................................... Print date: 18.03.15 Page: 1 of 2 S.C.M. Società Chimica Mugello S.r.l. a socio unico Via E. Mattei, 26 50039 Vicchio (FI) / Italia T +39 055-843901 – F +39 055-844730 Registro Imprese Firenze 01423760485 REA: FI-268661 Cap. Soc. euro 1.820.000,00 i.v. Cod. Fisc. 01423760485 P. Iva 13145910157 Lactulose Solution SPECIFICATION EP Revision date: 05.03.2015 ................................................................................................................................................................................................................................................................. Additional tests Specific optical rotation -17.0° to -25.0° Refractive index n 20/d ≥ 1.451 Density ≤ 1.380 g/ml Microbial contamination: Salmonella Absence of Salmonella sp./10g Remark: Test for boron and methanol as basically required in the EP monograph omitted as neither substance is used in the production process. Would comply if tested. ................................................................................................................................................................................................................................................................... Print date: 18.03.15 Page: 2 of 2 S.C.M. Società Chimica Mugello S.r.l. a socio unico Via E. Mattei, 26 50039 Vicchio (FI) / Italia T +39 055-843901 – F +39 055-844730 Registro Imprese Firenze 01423760485 REA: FI-268661 Cap. Soc. euro 1.820.000,00 i.v. Cod. Fisc. 01423760485 P. Iva 13145910157 Lactulose Solution SPECIFICATION USP Revision date: 09.03.2015 ................................................................................................................................................................................................................................................................. Tests Limits or Requirements Characters Dense liquid, colorless or slightly yellow, odorless, and clear or not more than slightly opalescent. Identification Identification tests A, B: positive pH 2.5 to 6.5 Refractive index n 20/d ≥ 1.451 Lactulose assay (HPLC) 95.0 to 105.0 % of the declared content Galactose corresponding to lactulose Not more than 16.0 % Lactose corresponding to lactulose Not more than 12.0 % Epilactose corresponding to lactulose Not more than 8.0 % Fructose corresponding to lactulose Not more than 1.0 % Residue on ignition Not more than 0.1 % Total aerobic microbial count Not more than 100 CFU/g Salmonella sp. Negative/10g Escherichia coli Negative/g Additional tests Tagatose corresponding to lactulose Not more than 4.0 % 3-Deoxy-glyceropentulose corresponding to lactulose Not more than 4.0 % Unknown impurity G corresponding to lactulose Not more than 1.5 % Unknown impurity H corresponding to lactulose Not more than 1.5 % Single unspecified impurity corresponding to lactulose Not more than 0.5 % ................................................................................................................................................................................................................................................................... Print date: 18.03.15 Page: 1 of 2 S.C.M. Società Chimica Mugello S.r.l. a socio unico Via E. Mattei, 26 50039 Vicchio (FI) / Italia T +39 055-843901 – F +39 055-844730 Registro Imprese Firenze 01423760485 REA: FI-268661 Cap. Soc. euro 1.820.000,00 i.v. Cod. Fisc. 01423760485 P. Iva 13145910157 Lactulose Solution SPECIFICATION USP Revision date: 09.03.2015 ................................................................................................................................................................................................................................................................. Tests Limits or Requirements Additional tests Sum of impurities eluting after impurity H corresponding to lactulose Not more than 1.3 % Total impurities excluding galactose and lactose corresponding to lactulose Not more than 12.0 % Color < 0.300 A.U. Density < 1.380 g/ml Specific optical rotation -17.0° to -25.0° Total molds and yeasts count Not more than 10 CFU/g ................................................................................................................................................................................................................................................................... Print date: 18.03.15 Page: 2 of 2 S.C.M. Società Chimica Mugello S.r.l. a socio unico Via E. Mattei, 26 50039 Vicchio (FI) / Italia T +39 055-843901 – F +39 055-844730 Registro Imprese Firenze 01423760485 REA: FI-268661 Cap. Soc. euro 1.820.000,00 i.v. Cod. Fisc. 01423760485 P. Iva 13145910157 Lactulose Solution SPECIFICATION JP Revision date: 09.03.2015 ................................................................................................................................................................................................................................................................. Tests Limits or Requirements Characters Clear, colourless or light yellow, viscous liquid Identification Identification test B: positive pH 3.5 to 5.5 Density 1.320 to 1.360 g/ml Sulfated ash Not more than 0.1 % Lactulose assay (HPLC) 50.0 to 56.0 % w/w Galactose Less than 11 % Lactose Less than 6.0 % Total aerobic microbial count Not more than 100 CFU/g Escherichia coli Absent/g Salmonella Absent/10g Total mould and yeast count Not more than 10 CFU/g Additional tests Appearance of solution Clear Specific optical rotation -17.0° to -25.0° Heavy metals (Lead) < 0.5 ppm ................................................................................................................................................................................................................................................................... Print date: 18.03.15 Page: 1 of 1
> 0.68 g/ml
