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PRODUCT NAME: Mannitol
CHARACTERISTICS:
Monograph Name: Mannitol
Inn Name: Mannitol
Chemical Name: D-Mannitol
CAS-Number: 69-65-8
Structural Formula:
Molecular Formula: C6H14O6
Molecular Weight: 182.2
APPLICATION:
It is widely used in fields of intravenous injection and oral medicine, light industry, food and chemical industry.
SPECIFICATION:
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Test |
Specifications |
Reference |
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Description |
White or almost white, crystalline powder or free-flowing granules. |
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Solubility |
Freely soluble in water, very slightly soluble in ethanol (96 per cent). |
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Identification |
A. Specific optical rotation: +23 to +25° (anhydrous substance). B. Melting point: 165 to 170°C. C. Infrared absorption spectrophotometry. D. Thin-layer chromatography. |
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Appearance of Solution |
The solution is clear and colourless |
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Conductivity |
Maximum 20 µS·cm-1. |
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Reducing Sugars |
Maximum 0.2% (calculated as glucose equivalent). |
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Related Substances |
Individual impurity: NMT 0.1% Total Impurities: NMT 2.0% |
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Lead |
Maximum 0.5 ppm. |
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Nickel |
Maximum 1 ppm. |
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Water |
Maximum 0.5% |
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Microbial Contamination |
Not more than 102 bacteria and 102 fungi per gram. |
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Bacterial Endotoxins |
Less than 4 IU/g for parenteral dosage forms having a concentration of 100 g/l or less of mannitol, and less than 2.5 IU/g for parenteral dosage forms having a concentration of more than 100 g/l of mannitol. |
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Assay |
98.0 per cent to 102.0 per cent (anhydrous substance). |
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PACKAGE:
25kgs craft paper bags, 18MT per 20’ container without pallet and 16MT with pallets.
STORAGE AND TRANSPORTATION:
The product should be stored on the pallet, and a light-proof, well-closed, dry and cool place. Following the above guidelines should insure 24-month shelf life. After opening the original packing, the complete content should be used immediately. Material can be microbiologically contaminated from unhygienic environment. It is a non-dangerous product and can be transported as a common chemical product. Protect them from sunshine or rain. Must not be loaded and transported with toxic, hazard outstand polluting substances. Handle with care in order to avoid damaging the package.
QUALITY AND SAFETY ASSURANCE:
Controlled under certified quality system ISO and product safety is ensured by established safety system.
TEST METHOD: Full details and test method are available on request.