Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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D-Mannitol
SKU:
TC513M
CAS Number :
69-65-8
Molecular Formula :
C₆H₁₄O₆
Availability: In stock
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$51.60
Product Identifier
| Product Code | TC513M |
|---|---|
| Molecular weight | 182.172 |
| Molecular formula | C6H14O6 |
| CAS No. | 69-65-8 |
| Shelf life | 48 months |
Technical Specification
| Meets Specifications | USP 41-NF 36, EP 9.0, JP 17, BP 2016 and IP 2018 testing specifications |
|---|---|
| Appearance (USP, IP) | White crystalline powder or free-flowing granules. |
| Appearance (EP, BP) | White or almost white crystals or powder |
| Appearance (JP) | White crystals or powder or grain |
| Solubility (USP) | Freely soluble in water, soluble in alkaline solutions; slightly soluble in pyridine; very slightly soluble in alcohol; practically insoluble in ether. |
| Solubility (EP, BP) | Freely soluble in water, practically insoluble in 96% ethanol |
| Solubility (JP) | It is freely soluble in water, practically insoluble in ethanol (99.5%). It dissolve in sodium hydroxide TS. |
| Solubility (IP) | Freely soluble in water, slightly soluble in pyridine; very slightly soluble in ethanol (95%); insoluble in chloroform and in ether |
| Identification, FTIR (JP) | Matches with the standard pattern |
| Identification A, FTIR (USP, IP) | Matches with the standard pattern |
| Identification A, Specific rotation (EP, BP) | +23.00° to +25.00° (c = 2g sample + 2.6 g of disodium tetraborate + 20 mL of water, shake for 15-30 min., dilute the solution to 25 mL with water at 25°C) |
| Identification B (IP) | A clear solution is obtained which remains clear on the further addition of sodium hydroxide solution. |
| Identification B, Melting range (EP, BP) | 165-170°C |
| Identification C (IP) | A pink colour is produced. |
| Identification C, FTIR (EP, BP) | Matches with the standard pattern |
| Identification D, Melting range (IP) | 165-170°C |
| Identification D, TLC (EP, BP) | The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution |
| Appearance of solution (USP, EP, BP, IP) | The solution is clear and colourless |
| Clarity and colour of solution (JP) | 10% solution is clear and its colour is not more intense than the control solution |
| Specific rotation (EP, BP, IP) | +23.00° to +25.00° (c = 2g sample + 2.6 g of disodium tetraborate + 20 mL of water, shake for 15-30 min., dilute the solution to 25 mL with water at 25°C) |
| Melting range (USP, EP, BP, JP) | 165-170°C |
| Nickel (USP, EP, BP, JP) | <= 0.0001% |
| Heavy metals (BP, JP) | <= 0.0005% |
| Arsenic (IP) | <= 0.0002% |
| Acidity or alkalinity (IP) | <= 0.3 ml of 0.01M HCl is required to change the colour of the solution to red |
| Chloride (IP) | <= 0.005% |
| Sulphate (IP) | <= 0.01% |
| Glucose: KMnO4 titration (JP) | <= 0.1% |
| Conductivity (USP, EP, BP, JP) | <= 20 µS.cm-¹ at 25°C |
| Reducing sugar (USP, EP, BP) | <= 0.1% |
| Reducing sugar (IP) | >= 12.8 ml of 0.05m sodium thiosulphate is required |
| Sorbitol : TLC (IP) | Any spot corresponding to sorbitol in the chromatogram obtained with the test solution is is not more intense than the spot in the chromatogram obtained with the reference solution |
| Related substance : system suitability : Resolution : solution A : HPLC (USP, EP, BP) | >= 2.0 |
| Related substance : system suitability : Resolution : solution B : HPLC (USP, EP, BP) | >= 2.0 |
| Related substance: system suitability : Relative standard deviation: HPLC (JP) | <= 1.0% |
| Related substance, Impurity A : D-Sorbitol (USP, EP, BP, JP) | <= 2.0% |
| Related substance, Sum of impurity B (D-mannitol) and impurity C (Isomalt) (USP, EP, BP, JP) | <= 2.0% |
| Related substance, Unspecified impurities (USP, EP, BP, JP) | <= 0.10% |
| Related substance, Total impurity (USP, EP, BP, JP) | <= 2.0% |
| Sulphated ash (IP) | <= 0.1% |
| Loss on drying (at 105°C, 4 hr) (USP, EP, BP, JP, IP) | <= 0.50% |
| Bacterial endotoxin: 100g/l or less of mannitol (USP, EP, BP, IP) | <= 4 IU/g |
| Bacterial endotoxin : more than 100g/l of mannitol (USP, EP, BP, IP) | <= 2.5 IU/g |
| Microbial contamination : TAMC (USP, BP, EP) | <= 100 CFU/g |
| Microbial contamination : TYMC (USP, BP, EP) | <= 100 CFU/g |
| Assay (HPLC, on dry basis) (USP, EP, BP, JP, IP) | 97.0-102.0% |
| Store below | 30°C |
CAS Number :
69-65-8
Molecular Formula :
C₆H₁₄O₆
| Product Name | D-Mannitol |
|---|---|
| SKU | TC513M |
| CAS No | 69-65-8 |
| EC No. | 200-711-8 |
| Molecular formula | C₆H₁₄O₆ |
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