Lactulose Crystals (medium) SPECIFICATION EP

Lactulose Crystals (medium) 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 Crystals (medium)
SPECIFICATION EP
Revision date: 05.03.2015
.................................................................................................................................................................................................................................................................
Tests
Limits or Requirements
Characters
White or almost white crystalline powder
Identification
Identification tests B, C, D, E: positive
Appearance of solution
Clear, not more intensely coloured
than reference solution BY5
pH
3.0 to 7.0
Specific optical rotation
- 46.0° to - 50.0° on a.b.
Water
≤ 2.5 %
Lactulose assay (HPLC)
97.0 to 102.0 % a.b.
Lactose
≤ 3.0 % w/w
Galactose
≤ 0.5 % w/w
Epilactose
≤ 0.5 % w/w
Tagatose
≤ 0.5 % w/w
Fructose
≤ 0.5 % w/w
Unspecified impurities
≤ 0.5 % w/w
Total of impurities
≤ 3.0 % w/w
Lead
Not more than 0.5 ppm
Sulphated ash
Not more than 0.1 %
Microbial contamination
Total viable aerobic count not more
than 102 CFU/g
Absence of Escherichia coli/g
Additional tests
Bulk density
> 0.68 g/ml
Particle size
Max. 40 % < 100 microns
Flowability
< 30 sec.
Microbial contamination
Absence of Salmonella sp./10g
Total combined yeasts/moulds count not
more than 102 CFU/g
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: 1 of 1
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 Crystals (fine)
SPECIFICATION EP
Revision date: 05.03.2015
.................................................................................................................................................................................................................................................................
Tests
Limits or Requirements
Characters
White or almost white crystalline powder
Identification
Identification tests B, C, D, E: positive
Appearance of solution
Clear, not more intensely coloured
than reference solution BY5
pH
3.0 to 7.0
Specific optical rotation
- 46.0° to - 50.0° on a.b.
Water
≤ 2.5 %
Lactulose assay (HPLC)
97.0 to 102.0 % a.b.
Lactose
≤ 3.0 % w/w
Galactose
≤ 0.5 % w/w
Epilactose
≤ 0.5 % w/w
Tagatose
≤ 0.5 % w/w
Fructose
≤ 0.5 % w/w
Unspecified impurities
≤ 0.5 % w/w
Total of impurities
≤ 3.0 % w/w
Lead
Not more than 0.5 ppm
Sulphated ash
Not more than 0.1 %
Microbial contamination
Total viable aerobic count not more
than 102 CFU/g
Absence of Escherichia coli/g
Additional tests
Particle size
Min. 97 % < 250 microns
Microbial contamination
Absence of Salmonella sp./10g
Total combined yeasts/moulds count not
more than 102 CFU/g
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: 1 of 1