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D-(-)-Mannitol 97.0-102.0% Ph. Eur., USP

Supplier: VWR Chemicals

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Synonyms: Mannitol

25311.468EA 0 INR InStock
25311.468 25311.366 25311.297
D-(-)-Mannitol 97.0-102.0% Ph. Eur., USP
D(-)-Mannitol
Appearance: White or almost white crystals or powder.

Caution: Not for use as Active Pharmaceutical Ingredient (API)


Formula: HOHâ‚‚C(CH(OH))â‚„CHâ‚‚OH
MW: 182.17 g/mol
Boiling Pt: 290…295 °C (4 hPa)
Melting Pt: 164…169 °C
Density: 1,49 g/cm³ (20 °C)
Storage Temperature: Ambient
 MDL Number: MFCD00064287
CAS Number: 69-65-8
EINECS: 200-711-8
UN: 0000
Merck Index: 13,05769
https://b2b-in-gqp.vwr.com/stibo/web/std.lang.all/06/13/16640613.jpg
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Specification Test Results
Appearance Conforms (see CoA/CoS)
Heavy metals (as Pb) Max. 5 ppm
Residual solvents Unlikely by manuf.process
Metal catalysts Unlikely by manuf.process
As (Arsenic) Max. 2 ppm
Cd (Cadmium) Max. 1 ppm
Co (Cobalt) Max. 1 ppm
Hg (Mercury) Max. 2 ppm
Pb (Lead) Max. 3 ppm
V (Vanadium) Max. 1 ppm
Conforms to Ph.Eur./USP Passes test
Ph.Eur. specifications:
Assay (dried substance) [Ph.Eur.] 97.0 --> 102.0 %
Identification C Passes test Ph.Eur.
Appearance of solution Passes test Ph.Eur.
Conductivity (20°C; 20 %) [Ph.Eur.] Max. 20 μS/cm
Melting point [Ph.Eur.] 165 --> 170 °C
Reducing sugars (as C6H12O6) [Ph.Eur.] Max. 0.1 %
D-Sorbitol [Ph.Eur.] Max. 2.0 %
D-Maltitol and isomalt [Ph.Eur.] Max. 2.0 %
Unspecified impur. (for each) [Ph.Eur.] Max. 0.10 %
Total impurities [Ph.Eur.] Max. 2.0 %
Disregard limit [Ph.Eur.] Max. 0.05 %
Loss on drying (105°C; 4 h) [Ph.Eur.] Max. 0.5 %
TAMC [Ph.Eur.] Max. 1000 CFU/g
TYMC [Ph.Eur.] Max. 100 CFU/g
Escherichia coli [Ph.Eur.] Absent
Salmonella [Ph.Eur.] Absent
USP specifications:
Assay (calculated on dried basis) [USP] 97.0 --> 102.0 %
Identification A Passes test USP
Disregard limit [USP] Max. 0.05 %
Sorbitol [USP] Max. 2.0 %
Sum of isomalt and maltitol [USP] Max. 2.0 %
Unspecified impurities [USP] Max. 0.10 %
Total impurities [USP] Max. 2.0 %
Reducing sugars (as C6H12O6) [USP] Max. 0.1 %
Ni (Nickel) [USP] Max. 1 μg/g
Melting point [USP] 165 --> 170 °C
Appearance of solution Passes test USP
Loss on drying (105°C; 4 h) [USP] Max. 0.5 %
Conductivity (25°C; 20 %) [USP] Max. 20 μS/cm
TAMC [USP] Max. 1000 CFU/g
TYMC [USP] Max. 100 CFU/g
Escherichia coli [USP] Absent

 

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