D-Mannitol

CAS Number: 69-65-8   |   Synonyms: Mannite


Product InfoStructurePhysical PropertiesProduct DataTransportation DataSpecification Sheet

PRODUCT INFORMATION

Product Name:
D-Mannitol

Product Description:
Tested to USP, EP

Quality Grade:
non-GMP

Usage Unit:
KG

Source:
Synthetic

Synonyms:
Mannite

STRUCTURE

Tested to USP, EP

SKU: 69658 Category:
PHYSICAL PROPERTIES
S.NOPropertyValueReference
1Mp165-170 °C (EP<2.2.14>) (USP<741>)-
PRODUCT DATA

Molecular Formula:
C6H14O6

Molecular Weight:
182.17

EC Number:
200-711-8

Category:
CELL MEDIA COMPONENTS

Functional Categories:
MASKING;MOISTURISING;SKIN CONDITIONING;BINDING;HUMECTANT;

Purity Value:
-

Storage Temperature:
Ambient

INCI Name:
MANNITOL

TRANSPORTATION DATA

UN Class:
-

UN Packing Group:
-

Harmonized Tariff Number:
2905.43.0000

UN Number:
-

SPECIFICATION SHEET

Rev No:
1

SPECIFICATION DATA

S.NOGroupingAnalytical TestSpecification
1-IdentityIR (EP<2.2.24>) (USP<197K>)
2-IdentityTLC (EP<2.2.27>)
3-Sp. Rot.+23° to +25° (EP<2.2.7>)
4-Mp165-170 °C (EP<2.2.14>) (USP<741>)
5-AppearanceWhite microcryst. solid
6-SolubilityFreely soluble in water, practically insoluble in Ethanol (96%)
7-Appearance of SolutionClear (2.2.1), colorless (2.2.2, Method II) solution (EP) (USP)
8-Assay97%-102% (EP<2.2.29>) (USP)
9-Related Substances(EP<2.2.29>) (USP)
10-Impurity A(D-Sorbitol) ≤ 2%
11-impurity B(D-Maltitol) ≤2%
12-Impurity C(Isomalt) ≤2%
13-Unknown Impurities≤ 0.1%
14-Total Impurities≤ 2.0%
15-Conductivity≤ 20 uScm-1 (EP<2.2.38>) (USP)
16-Reducing SugarsConforms (USP) (EP)
17-LOD≤ 0.5% (EP<2.2.32>) (USP<731>)
18-Residual Solvents (GC)(USP) Meets USP <467> specifications
19--Pb≤ 5 ppm (EP)
20--Ni≤ 1.0 ppm (EP<2.4.15>) (AAS : USP<852>)
21Microbiological Specifications--
22-Total Aerobic (CFU/g)≤ 100 CFU/g (EP <2.6.12>) (USP<62>)
23-E. ColiNegative
24-SalmonellaNegative
25-Staphylococcus aureusNegative
26-Pseudomonas aeruginosaNegative
27-Mold and Yeast≤ 100 CFU/g (EP <2.6.12>) (USP<62>)
28-Endotoxin Level≤ 4 IU/ g (EP <2.6.14>) (USP<85>)
29Manufacturing and Regulatory Data--
30-Date of Manufacture-
31-Retest Date2 years

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