Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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D-(-)-Sorbitol
SKU:
TC170M
CAS Number :
50-70-4
Molecular Formula :
C₆H₁₄O₆
Availability: In stock
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Product Identifier
| Product Name | D-(-)-Sorbitol |
|---|---|
| Specifications | Meets USP-NF, EP, BP, JP and IP testing specifications |
| Product Code | TC170M |
Product Details
| Molecular weight | 182.17 |
|---|---|
| Molecular formula | C6H14O6 |
| CAS No. | 50-70-4 |
Quality Control
| Appearance (USP) | White granules, powder, or crystalline masses |
|---|---|
| Appearance (EP, BP) | White or almost white, crystalline powder |
| Appearance (JP) | White, granules, powder, or crystalline masses |
| Appearance (IP) | A white crystalline powder |
| Solubility (USP) | Very soluble in water, sparingly soluble in alcohol; and practically insoluble in ethyl ether. |
| Solubility (EP, BP) | Very soluble in water, practically insoluble in ethanol (96%) |
| Solubility (JP) | Very soluble in water, sparingly soluble in ethanol (95%), and practically insoluble in diethyl ether |
| Solubility (IP) | Very soluble in water, sparingly soluble in ethanol (95%), and practically insoluble in chloroform and in ether |
| pH (USP) | 3.50-7.00 (10% w/w solution in carbon dioxide free water) |
| Clarity and colour of solution (USP) | 10% solution in carbon dioxide-free water is clear and colourless |
| Clarity and colour of solution (JP) | 25% solution in warm water is Clear and colourless |
| Acidity or alkalinity (JP) | 25% solution in warm water is neutral |
| Acidity or alkalinity 1 (IP) | <= 0.2 mL of 0.01M sodium hydroxide is required to change the colour of the solution to pink |
| Acidity or alkalinity 2 (IP) | <= 0.3 mL of 0.01M hydrochloric acid is required to change the colour of the solution to red |
| Appearance of solution (EP, BP, IP) | 10% solution in water is clear and colourless |
| Identification A (USP) | A deep pink or wine-red color appears |
| Identification A (EP, BP) | The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a) |
| Identification A (IP) | The principal peak in the chromatogram obtained with the test solution corresponds to the principal peak in the chromatogram obtained with reference solution (a) |
| Identification 1 (JP) | A blue-green color develops, but no turbidity is produced |
| Identification B (USP) | The retention time of the major peak of the sample solution corresponds to that from the standard solution, as obtained in the assay |
| Identification B (EP, BP) | The precipitate, recrystallized from a small volume of ethanol (96%)R and dried in vacuo, melts at 98°C to 104°C |
| Identification B (IP) | A pink colour is produced |
| Identification 2 (JP) | A reddish purple to red-purple color immediately develops |
| Identification Test C : TLC (EP, BP) | The principal spot in the chromatogram obtained with the test solution is similar in positon, colour and size to the principal spot in the chromatogram obtained with reference solution (a) |
| Identification C (IP) | The residue, after washing rapidly with 5 mL of mixture of equal volumes of methanol and water and drying in a current of air, melts at about 175° |
| Identification 3 : (JP) | The precipitate, recrystallized from a small volume of ethanol (96%)R and dried in vacuo, melts at 97°C to 101°C |
| Identification D: (EP, BP) | +4.00° to +7.00° (c = 5gm substance and 6.4 gm of disodium tetraborate in 40 mL of water R. Allow to stand for 1 h and dilute to 50 mL with water R, at 20 ± 0.5°C, anhydrous basis) |
| Specific rotation (EP, BP) | +4.00° to +7.00° (c = 5gm substance and 6.4 gm of disodium tetraborate in 40 mL of water R. Allow to stand for 1 h and dilute to 50 mL with water R, at 20 ± 0.5°C, anhydrous basis) |
| Specific rotation (IP) | +4.00° to +7.00° (c = 5gm substance and 6.4 gm of borax in 40 mL of water, allow to stand for 1 h, shaking dilute to 50 mL with water and filter if necessary |
| Limit of Nickel (USP) | <= 0.0001% |
| Nickel (IP) | <= 0.0001% |
| Nickel (JP) | No red color develops |
| Chloride (USP, JP, IP) | <= 0.0050% |
| Sulfate (JP) | <= 0.006% |
| Sulfate (USP) | <= 0.01% |
| Sulfate (IP) | <= 0.0125% |
| Heavy metals (JP) | <= 0.0005% |
| Heavy metals (IP) | <= 0.001% |
| Residue on ignition (USP) | <= 0.10% |
| Residue on ignition (JP) | <= 0.02% |
| Arsenic (JP) | <= 0.00013% |
| Arsenic (IP) | <= 0.0002% |
| Water (USP, EP, BP, IP) | <= 1.50% |
| Conductivity (EP, BP) | <= 20 µs.cm-1 |
| Reducing sugars (USP) | <= 0.3% |
| Reducing sugars (EP, BP, IP) | NLT 12.8 mL of 0.05M sodium thiosulfate is required |
| Glucose (JP) | NMT 6.3 mL of volume for titration consumed |
| Sugars (JP) | Complies |
| Sulphated ash (IP) | <= 0.10% |
| Loss on drying (JP) | <= 2.00% (0.5g in vacuum, phosphorus (V)oxide, 80°C, 3 hr) |
| Related substances, system suitability, HPLC : Resolution : (EP, BP, IP) | min. 2.00 between the peaks due to impurity A and sorbitol |
| Related substances, any impurity, HPLC : (EP, BP, IP) | <= 2.00% |
| Related substances, total impurity, HPLC : (EP, BP, IP) | <= 3.00% |
| System suitability, assay, HPLC : Resolution : (USP) | >= 2.0 between sorbitol and mannitol |
| System suitability, assay, HPLC : RSD : (USP) | <= 2.00% |
| Assay (HPLC, on anhydrous basis) : (USP) | 91.00 - 100.50% |
| Assay (HPLC, on anhydrous basis) : (EP, BP) | 97.00 - 102.00% |
| Assay (HPLC, on anhydrous basis) : (IP) | 98.00 - 101.00% |
| Assay (Iodometry, dried sample) : (JP) | >= 97.00% |
| Microbial contamination (TAMC) : (USP, EP, BP) | <= 1000 cfu/g |
| Microbial contamination (TYMC) : (USP, EP, BP) | <= 100 cfu/g |
| Microbial contamination (Pathogen, E.Coli, Salmonella) : (EP, BP) | Absent |
| Bacterial endotoxins, <100 g/L sorbitol : (USP, EP, BP) | NMT 4 IU/g |
| Bacterial endotoxins, 100 g/L or more of sorbitol : (USP, EP, BP) | NMT 2.5 IU/g |
| Bacterial endotoxins, <10% w/v of sorbitol : (IP) | NMT 4 EU/g |
| Bacterial endotoxins, 10% W/V or more of sorbitol : (IP) | NMT 2.5 EU/g |
Storage and Shelf Life
| Storage conditions | Store below 30°C away from bright light. |
|---|---|
| Shelf life | 48 months. |
| Usage information | Use before expiry date given on the product label. |
CAS Number :
50-70-4
Molecular Formula :
C₆H₁₄O₆
| Product Name | D-(-)-Sorbitol |
|---|---|
| SKU | TC170M |
| CAS No | 50-70-4 |
| EC No. | 200-061-5 |
| Molecular formula | C₆H₁₄O₆ |
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