Parteck® M 200 (Mannitol) 98.0-101.0% (by HPLC on dried basis), EMPROVE® ESSENTIAL BP, JP, Ph. Eur., USP, E421, SAFC®
Catalog #: CA1.00419.9025
Supplier: EMD MILLIPORE – PCS CA EXCEP
CAS Number: 69-65-8
Restricted Products: To process your orders without delay, please provide the required business documentation to purchase this product.
To order chemicals, medical devices, or other restricted products please provide ID that includes your business name & shipping address via email [email protected] or fax 484.881.5997 referencing your VWR account number. Acceptable forms of ID are:
- • State issued document with your organization's Federal Tax ID Number
- • State issued document with your organization's Resale Tax ID Number
- • City or County issued Business License
- • State Department of Health Services License
- • Any other ID issued by the State that includes the business name & address
* ATTN: California Customers may require additional documentation as part of the CA Health & Safety Code. Products that fall under this regulation will be placed on a mandatory 21-day hold after documentation is received. VWR will not lift restrictions for residential shipping addresses.
Specifications
- Packaging:Fibre carton
- Size:25 kg
- Cat. no.:CA1.00419.9025
- Supplier No.:1.00419.9025
Specifications
Specification Test Results
- Assay (HPLC, calc. on dried substance):98.0 - 101.0 %
- Identity (NIR):passes test
- Identity (IR-spectrum):passes test
- Identity (wet chemistry):passes test
- Appearance of solution (13 %; water):passes test
- Free acid:passes test
- pH-value (10 %; water):4.5 - 7.5
- Melting point:166 - 169
- Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance):137 - 145 °
- Conductivity (25°C) (20 %; water):≤ 20
- Arsenic (As):≤ 2
- Ni (Nickel) (#):≤ 1
- Pb (Lead):≤ 0.5
- Chloride (Cl):≤ 0.003 %
- Sulfate (SO₄):≤ 0.01 %
- Heavy metals (as Pb):≤ 5 ppm
- Oxalate (C₂O₄):≤ 0.02 %
- 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 %
- Residual solvents (ICH Q3C):excluded by manufacturing process
- Related substances (HPLC) (Sum of all impurities):≤ 2.0 %
- Reducing sugars after hydrolysis/total sugar (as glucose):≤ 1
- Reducing sugars (as glucose):≤ 0.05
- Sulfated ash:≤ 0.1
- Loss on Drying (105 °C):≤ 0.30 %
- Water:≤ 0.5 %
- Particle size (< 53 µm):≤ 15 %
- Particle size (> 500 µm):≤ 15 %
- Microbiological test:passes test
- Colony count (aerobic bacteria (TAMC)):≤ 10³
- Colony count (Yeasts and moulds (TYMC)):≤ 10²
- Salmonella spp.:in 10 g Substance not detectable
- E.coli:in 1 g Substance not detectable
- Staphylococcus aureus:in 1g Substance not detectable
- Pseudomonas aeruginosa:in 1g Substance not detectable
- Candida albicans:In 1g Substance not detectable
- Elemental 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., BP, ChP, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.:
Specification Test Results
About this item
Synonyms: Mannitol,(2R,3R,4R,5R)-Hexane-1,2,3,4,5
Boiling Pt:290…295 °C (4 hPa)
Melting Pt:164…169 °C
Density:1.49 g/cm³ (20 °C)
:Length:
:Width:
:Height:
:Ø
:Thickness:
:98,0-101,0
:Boiling Pt:
:Boiling Pt: 290…295 °C (4 hPa)
:Melting Pt:
:Melting Pt: 164…169 °C
:Flash Pt:
:Flash Pt:
:M.W. 182.17 g/mol
Merck Index:13,05769
:Parteck® M 200 (Mannitol)
Formula:HOH₂C(CH(OH))₄CH₂OH
MW:182.17 g/mol
Storage Temperature:Ambient
MDL Number:MFCD00064287
CAS Number:69-65-8
EINECS:200-711-8
:290…295 °C (4 hPa)
Customers Who Bought This Also Bought