Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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Lactose monohydrate
SKU:
TC144M
CAS Number :
64044-51-5
Molecular Formula :
C₁₂H₂₂O₁₁.H₂O
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Product Description
| Product Code | TC144M |
|---|---|
| Molecular weight | 360.31 |
| Molecular formula | C12H22O11.H2O |
| CAS No. | 64044-51-5 |
Quality Control
| Appearance (USP) | White, free-flowing powder. |
|---|---|
| Appearance (EP, BP) | White or almost white, crystalline powder |
| Appearance (JP) | White crystals, powder or granulated powder |
| Appearance (IP) | A white or almost white crystalline powder |
| Solubility (USP) | Freely but slowly soluble in water; practically insoluble in alcohol |
| Solubility (EP, BP) | Freely soluble in water, practically insoluble in ethanol 96.0% |
| Solubility (JP) | It is freely soluble in water, practically insoluble in ethanol 99.5% |
| Solubility (IP) | Freely but slowly soluble in water, practically insoluble in ethanol 95.0% |
| Identification A : FTIR (USP, EP, BP, IP) | Matches with the standard pattern |
| Identification: absorption (JP) | Both spectra exhibit similar intensities of absorption at the same wave numbers |
| Identification B : TLC (USP) | The principal spot from the sample solution corresponds in appearance and Rf value to that from standard solution A. |
| Identification B : 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 reference solution (a) |
| Identification B (IP) | A red precipitate is formed |
| Identification C (EP, BP, IP) | A red colour develops |
| Identification D: water (EP, BP) | 4.5-5.5% |
| Acidity or alkalinity (USP) | <= 0.4 mL of 0.1N sodium hydroxide VS is required to produce a pink or red colour |
| Acidity or alkalinity (EP, BP) | <= 0.4 mL of 0.1M sodium hydroxide is required to change the colour of the indicator to pink or red |
| Acidity or alkalinity (IP) | <= 0.4 mL of 0.1M sodium hydroxide is required to change the colour of the solution to pink |
| Acidity or alkalinity (JP) | <= 0.4 mL of 0.1M/L sodium hydroxide VS is required to produce a pale red colour or red colour |
| Appearance of solution (EP, BP) | 10% solution in boiling water is clear and not more intensely coloured than reference solution BY7 |
| Appearance of solution (IP) | 10% solution in hot water is clear and not more intensely coloured than reference solution BYS7 |
| Clarity and colour of solution 1 : (USP, JP) | 10% solution in boiling water is clear and colourless or nearly colourless |
| Clarity and colour of solution 2 : UV Absorbance : (USP, JP) | <= 0.04 (at 400 nm) |
| Specific rotation (USP, EP, BP, JP) | +54.4° to +55.9° (c = 10% in water/NH3 at 20 ±0.5°C, anhydrous basis) |
| Specific rotation (IP) | +54.4° to +55.9° (c = 10% in water/NH3 at 25°C) |
| Sulfated ash (EP, BP, IP) | <= 0.10% |
| Residue on ignition (USP, JP) | <= 0.10% |
| Arsenic (IP) | <= 0.0001% |
| Heavy metals (JP, IP) | <= 0.0005% |
| Loss on drying (USP, JP) | <= 1.00% (at 80°C, 2 hr) |
| Water (USP, EP, BP, JP, IP) | 4.50 - 5.50% |
| Protein and light-absorbing impurities 1: Absorbance (USP, EP, BP, JP) | <= 0.25 (at 210 to 220nm) |
| Protein and light-absorbing impurities 2: Absorbance (USP, EP, BP, JP) | <= 0.07 (at 270 to 300nm) |
| Protein and light-absorbing impurities 3: Absorbance (EP, BP) | <= 0.04 (at 400nm) |
| Light absorption 1 (IP) | <= 0.25 (at 210 to 220nm) |
| Light absorption 2 (IP) | <= 0.07 (at 270 to 300nm) |
| Microbial load : TAMC (USP, EP, BP, JP, IP) | <= 100 CFU/g |
| Microbial load : TYMC (USP, JP) | <= 50 CFU/g |
Storage and Shelf Life
| Storage conditions | Store below 30°C away from bright light. |
|---|---|
| Shelf life | 48 months. |
| Use before expiry date | Use before expiry date given on the product label. |
CAS Number :
64044-51-5
Molecular Formula :
C₁₂H₂₂O₁₁.H₂O
| Product Name | Lactose monohydrate |
|---|---|
| SKU | TC144M |
| CAS No | 64044-51-5 |
| EC No. | 200-559-2 |
| Molecular formula | C₁₂H₂₂O₁₁.H₂O |
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