Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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D-(+)-Trehalose dihydrate
SKU:
TC177M
CAS Number :
6138-23-4
Molecular Formula :
C₁₂H₂₂O₁₁.2H₂O
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Product Information
| Product Code | TC177M |
|---|---|
| Molecular weight | 378.33 |
| Molecular formula | C12H22O11.2H2O |
| CAS No. | 6138-23-4 |
Technical Specification
| Appearance (USP) | White odourless, nonhygroscopic crystalline powder. |
|---|---|
| Appearance (EP, BP) | White or almost white, crystalline powder. |
| Appearance (JP) | White crystals or crystalline powder |
| Solubility (USP) | Soluble in water, solubility increase with temp.; practically insoluble in dehydrated alcohol |
| Solubility (EP, BP) | Freely soluble in water, slightly soluble in methanol, practically insoluble in ethanol(96%) |
| Solubility (JP) | It is freely soluble in water, and slightly soluble in methanol & in ethanol (99.5%). |
| Identification 1 (JP) | A purple color appears at the zone of contact |
| Identification A : FTIR (USP, EP, BP) | Matches with the standard pattern |
| Identification 2 (JP) | No brown colour appears |
| Identification B (USP) | A violet colour develops at the interface between the two solutions |
| Identification B (EP, BP) | A violet colour develops at the interface |
| Identification 3 (JP) | Both spectra exhibits similar intensities of absorption at the same wave numbers |
| Identification C (USP, EP, BP) | No brown colour developed |
| Appearance of solution (EP, BP) | 10% solution in water is clear and colourless |
| Colour & clarity of solution (USP) | The absorbance difference is NMT 0.100 |
| pH (10% w/v sol at 25°C (USP, EP, BP, JP)) | 4.50 - 6.50 |
| Chlorides (USP, EP, BP) | <= 0.0125% |
| Chlorides (JP) | <= 0.018% |
| Heavy metals (JP) | <= 0.0005% |
| Nitrogen (USP, JP) | <= 0.005% |
| Soluble starch (USP, EP, BP) | No blue colour develops |
| Residue on ignition (USP, JP) | <= 0.1% |
| Sulphates (USP, EP, BP) | <= 0.02% |
| Sulphate (JP) | <= 0.024% |
| Sulphated ash (EP, BP) | <= 0.1% |
| Specific rotation (USP) | +197.0° to +201.0° (c = 10% in water at 20°C) |
| Specific rotation (EP, BP, JP) | +197.0° to +201.0° (c = 10% in water at 20 ±0.5°C, anhydrous substance) |
| Water (K.F.) (USP, EP, BP, JP) | 9.00 - 11.00% |
| Related substance : HPLC (JP) | The total area of the peaks which are eluted before the peak of trehalose and the total area of the peaks which are eluted after the peak of trehalose obtained from the sample solution are both not larger than 1/2 times the peak area of trehalose obtained from the standard solution. |
| Related substance : System suitability : RSD : HPLC (JP) | <= 1.0% |
| Related substance, HPLC 1 : System suitability : Resolution (USP, EP, BP) | >= 1.5 between trehalose and maltotriose |
| Related substance, HPLC 2: System suitability : RSD : (USP) | <= 2.0% for trehalose peak |
| Related substance : HPLC (USP) | <= 0.5% |
| Related substances 1 : impurities A, B for each impurity : HPLC (EP, BP) | <= 0.50% |
| Related substances 2: unspecified impurities : HPLC (EP, BP) | <= 0.20% |
| Related substances 3: total impurities : HPLC (EP, BP) | <= 1.0% |
| Dextrin soluble starch & sulphite (JP) | A yellow colour appears, which is change to blue on addition of 1 drop of starch TS |
| Assay: System suitability 1 : Resolution 1 : HPLC (JP) | >= 1.5 between the peak of trehalose and maltotriose |
| Assay: System suitability 2: Resolution 2 : HPLC (JP) | >= 4.0 between the peak of trehalose and glucose |
| Assay: System suitability 3 : Resolution 3 : HPLC (JP) | >= 3.0 between the peak of glucose and the internal standard |
| Assay: System suitability : RSD : HPLC (JP) | The ratio of the peak area of trehalose to that of the internal standard is not more than 1.0% |
| Assay HPLC, anhydrous basis (JP) | 98.0 - 101.0% |
| Assay HPLC, anhydrous basis (USP, EP, BP) | 97.0 - 102.0% |
| Bacterial endotoxin 1 (EP, BP) | <= 4.0 IU/g for solutions with conc. 100g/L or less of trehalose dihydrate |
| Bacterial endotoxin 2 (EP, BP) | <= 2.5 IU/g for solutions with conc. more than 100g/L of trehalose dihydrate |
| Bacterial endotoxin (USP) | Complies |
| TAMC (USP, EP, BP) | 100cfu/g |
| TYMC (USP, EP, BP) | 100cfu/g |
| Salmonella species (USP, EP, BP) | Absent |
| Escherichia coli (USP, EP, BP) | Absent |
Storage and Shelf Life
| Storage | Store below 30°C away from bright light. |
|---|---|
| Shelf life | 48 months. |
| Usage note | Use before expiry date given on the product label. |
CAS Number :
6138-23-4
Molecular Formula :
C₁₂H₂₂O₁₁.2H₂O
| Product Name | D-(+)-Trehalose dihydrate |
|---|---|
| SKU | TC177M |
| CAS No | 6138-23-4 |
| EC No. | 202-739-6 |
| Molecular formula | C₁₂H₂₂O₁₁.2H₂O |
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