Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 87-78-5
- EC No.
- 201-770-2
- Technologies
Features & Benefits
Applications & Uses
- Markets
- Dosage Form
Properties
- Appearance
- White crystals
- Soluble in
- Water, Ethanol
- Insoluble in
- Ether
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Note
- "ChP" stands for Chinese Pharmacopeia
- (*)-Compliance data - Tests not performed
- (**)-Monitoring plan
| Value | Units | Test Method / Conditions | |
| Acidity | Complies | — | — |
| Chlorides Content | 30 | mg/kg | — |
| Clarity and Color of Solution | Complies | — | — |
| Escherichia Coli (**) | Not detected in 1g | — | — |
| Specific Optical Rotation | +137 to +145 | Degree | — |
| Heavy Metals Content (*) | max. 10 | mg/kg | — |
| Identification Test 1 (*) | Complies | — | ChP |
| Identification Test 2 (*) | Complies | — | ChP |
| Melting Point | 166 - 170 | °C | — |
| Oxalate Content (*) | max. 0.0002 | % | — |
| Reducing Sugars | Complies | — | — |
| Residue on Ignition | max. 0.001 | — | — |
| Sulfates Content | 100 | mg/kg | — |
| Total Impurities | max. 2.0 | % | — |
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 2 | mg/kg | — |
| Assay Content (on DS) | 98.0 - 102.0 | % | — |
| Loss on Drying | max. 0.5 | % | — |
| Value | Units | Test Method / Conditions | |
| Total Yeasts and Moulds Count | max. 100 | CFU/g | — |
| Bacterial endotoxins | max. 2.5 | IU/g | — |
| Total Aerobic Microbial Count | max. 1000 | CFU/g | Plate count |
| Salmonella (**) | Not detected | per 10g | — |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Conformity
Conforms to the requirements of the current monograph
- Chinese Pharmacopeia (ChP) MANNITOL
Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).
Technical Details & Test Data
- Test Data
This substance is suitable for use in manufacture of parenteral preparations. Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.
Packaging & Availability
- Packaging Information
- ROQ Product Code: 450002
- Article (SKU) Code: 450002107K
- Package Size & Type: 25 kg lined strippable paper bag
Storage & Handling
- Storage & Shelf Life
- Retest date Manufacturing date + 3 years, in its unopened packaging.
- The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labeling and CoA.
- We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.
- Upon opening, use the product as quickly as possible to prevent moisture regain.