Mannitol, Powder USP - GenAR, Suitable for Use in Biotechnology, Macron™
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Mannitol, Powder USP - GenAR, Suitable for Use in Biotechnology, Macron™
Formula: C6H14O6
Formula Weight: 182.17
Suitable for Use in Biotechnology
| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets U.S.P. Requirements |
| Assay (C6H14O6) (dried basis) |
96.0 - 101.5% |
| Acidity |
Passes Test |
| Arsenic (As) |
max. 0.0001% |
| Chloride (Cl) |
max. 0.007% |
| Identification |
Passes Test |
| Loss on Drying at 105°C |
max. 0.3% |
| Melting Range |
164 - 169°C. |
| Reducing Sugars |
Passes Test |
| Specific Rotation [a]25D |
137 - 145 Degree |
| Sulfate (SO4) |
max. 0.01% |
| |
| Meets BP/Ph.Eur. Chemical Specifications |
Assay (as C6H14O6)
(calculated on anhydrous basis) |
98.0 - 102.0% |
| Conductivity, μS cm -1 |
max. 20 |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Identification C |
Passes Test |
| Identification D |
Passes Test |
| Lead (Pb) |
max. 0.5 ppm |
| Nickel (Ni) |
max. 1 ppm |
| Water (H2O) |
max. 0.5% |
| Reducing Sugars |
max. 0.2% |
| Related Substances |
| Impurities A,B,C |
max. 2.0% |
| Any other Impurity |
max. 0.10% |
| Total |
max. 2.0% |
| Appearance of Solution |
Passes Test |
| Total Aerobic Microbial Count (cfu/g) |
max. 1000 |
| Total Mold and Yeast Count (cfu/g) |
max. 100 |
| Escherichia coli (absent) |
Passes Test |
| Salmonella (absent) |
Passes Test |
| |
| Endotoxin Concentration (EU/g) |
max. 10 |
| Product Information (not specifications): |
| Appearance (fine, white crystalline powder) |
| |
| Not Intended for Parenteral Use |
| Only Class 2 solvents (Ethylene Glycol) are likely to be present. All are below Option 1 limits. |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| For a Certificate of Lot Analysis, visit www.avantormaterials.com. |
| CAS Number |
69-65-8 |
| HTS Number |
2905430000 |
| Specific Gravity |
1L = 1.52 Kg |
| Storage Color Code |
Green |
| Management of Change |
R |