1.08346
EMPROVE® exp Ph Eur, BP, USP D(+)-Glucose monohydrate
suitable for use as excipient
For general questions please contact our Customer Service:
EMD Millipore
290 Concord Road
01821 Billerica, MA
United States
Phone: 800-645-5476
Fax: 800-645-5439
E-mail: Customer.CareDesk@emdchemicals.com
19 June 2013
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| Product information | |||
|---|---|---|---|
| Grade | BP, Ph Eur, USP | ||
| Synonyms | Dextrose | ||
| Chemical formula | C6H12O6·H2O | ||
| Molar mass | 198.17 | ||
| CAS number | 14431-43-7 | ||
| Chemical and physical data | |||
|---|---|---|---|
| Molar mass | 198.17 | ||
| Specifications | |
|---|---|
| Acidity or alkalinity | Conforms |
| Appearance of solution | Conforms |
| Arsenic (As) | 0.0001% max |
| Barium (Ba) | Conforms |
| Calcium (Ca) | 0.01% max |
| Chloride (Cl) | 0.005% max |
| Copper (Cu) | 0.0025% max |
| Endotoxins | 2.5IU/g max |
| Foreign sugars, soluble starch, dextrines | Conforms |
| Heavy metals (as Pb) | 0.0005% max |
| Identity | Passes test |
| Lead (Pb) | 0.00005% max |
| Microbial purity- Bile tolerant Gram Neg Bacteria | Absent in 1 g |
| Microbial purity- Candida albicans | Absent in 1 g |
| Microbial purity- Escherichia coli | Absent in 1 g |
| Microbial purity- Pseudomonas aeruginosa | Absent in 1 g |
| Microbial purity- Salmonella ssp | Absent in 10 g |
| Microbial purity- Staphylococcus aureus | Absent in 1 g |
| Microbial purity- Total aerobic microbial count | 100CFU/g max |
| Microbial purity- Total yeast and mold count | 1000CFU/g max |
| Residual Solvents (Ph.Eur./USP/ICH) | Excluded by manufacturing process |
| Specific rotation [a]20/D (c=10, water, anhydrous) | +52.6-+53.2° |
| Specific rotation [a]25/D (c=10, water, anhydrous) | +52.6-+53.2° |
| Sulfate (SO4) | 0.01% max |
| Sulfated ash | 0.1% max |
| Sulfite (SO2) | Passes test |
| Water | 7.5-9.5% |
| Zinc (Zn) | 0.0025% max |
