甘露醇（低内毒素，原料药级，JXHL1300010国，DMF）Mannitol 105303

货号：105303

品名：D（-）-Mannitol low in endotoxins, suitable for use as an active pharmaceutical ingredient EMPROVE® api Ph Eur,BP,USP,JP

中文名：甘露醇（低内毒素，原料药级，JXHL1300010 国, DMF）

内毒素：≤1 I.U./g

TAMC（总菌）：≤200 CFU/g

TYMC（霉菌/酵母）：≤100 CFU/g

规格
Assay (HPLC, calc. on dried substance)	98.0 - 101.0 %
Identity (IR-spectrum)	passes test
Appearance of solution (10 %; water)	passes test
pH-value (10 %; water)	4.5 - 7.5
Melting point	165 - 169
Conductivity (25°C) (20 %; water)	≤ 20
Heavy metals (as Pb)	≤ 0.0005 %
Ni (Nickel)	≤ 0.0001 %
Pb (Lead)	≤ 0.00005 %
Related substances (HPLC) (Sorbitol (Impurity A))	≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C))	≤ 2.0
Related substances (HPLC) (Major unspecified impurity)	≤ 0.10 %
Related substances (HPLC) (Sum of all impurities)	≤ 2.0 %
Reducing sugars (as glucose)	≤ 0.05
Reducing sugars after hydrolysis/total sugar (as glucose)	≤ 1
Sulfated ash	≤ 0.1
Water	≤ 0.5
Loss on Drying (105°C)	≤ 0.30 %
Residual solvents (ICH Q3C)	excluded by manufacturing process
Microbiological test	passes test
Colony count (aerobic bacteria (TAMC))	≤ 10²
Colony count (Yeasts and moulds (TYMC))	≤ 10²
Salmonella species	In 10g substance not detectable
E.coli	In 1g substance not detectable
Staphylococcus aureus	In 1g substance not detectable
Pseudomonas aeruginosa	In 1g substance not detectable
Candida albicans	In 1g substance not detectable
Endotoxins (kinetic turbidimetric test)	≤ 1
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph. Eur., BP, USP, JP