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102776 SAFC

Trehalose dihydrate

EMPROVE® EXPERT Ph Eur,NF,JP

Synonym: 1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside, Trehalose dihydrate

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Properties

Agency/Method   JP
  NF
  Ph Eur
mp   96.5-97.5 °C
InChI   1S/C12H22O11.2H2O/c13-1-3-5(15)7(17)9(19)11(21-3)23-12-10(20)8(18)6(16)4(2-14)22-12;;/h3-20H,1-2H2;2*1H2/t3-,4-,5-,6-,7+,8+,9-,10-,11-,12-;;/m1../s1
InChI key   DPVHGFAJLZWDOC-PVXXTIHASA-N
storage conditions   no restrictions.

Description

General description

EMPROVE® EXPERT Ph Eur,NF,JP

Analysis Note

Assay (HPLC, calc. on anhydrous substance)98.0 - 101.0 %Identity (IR)conformsAppearance (color)white to almost whiteAppearance (description)crystalline powderAppearance of solution (clearness)clear to almost clearAppearance of solution (color)colorless to almost colorlessColor and clarity of solution, absorbance at 720 nm≤ 0.050Color and clarity of solution, absorbance 420 – 720 nm≤ 0.100pH-value4.5 - 6.5Spec. rotation [α²0/D (calc.on anhydrous substance)+197 - +201 °Chloride≤ 125 ppmSulfate≤ 200 ppmNitrogen (N)≤ 0.005 %Heavy metals (as Pb)≤ 5 ppmRelated substances glucose (impurity A)≤ 0.5 %Related substances maltotriose (impurity B)≤ 0.5 %Unknown substances (total HPLC)≤ 0.2 %Sum of all impurities (HPLC)≤ 1.0 %Residual solvents of class 2 (ICH Q3C) Methanol≤ 3000 ppmOther residual solvents (ICH Q3C)excluded by manufacturing processSoluble StarchconformsResidue on ignition≤ 0.1 %Water (according to Karl Fischer)9.0 - 11.0 %Endotoxins≤ 0.3 I.U./gTAMC (Total aerobic microbial count)≤ 100 CFU/gTYMC (total yeast and mould count)≤ 10 CFU/gE.coli (absent in 1 g)conformsSalmonella spp. (absent in 10 g)conformsElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph.Eur.,NF,JP

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

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