Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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D-Biotin
SKU:
TC096M
CAS Number :
58-85-5
Molecular Formula :
C₁₀H₁₆N₂O₃S
Availability: In stock
Only %1 left
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Meets USP-NF, EP, BP and JP testing specifications
CAS Number :
58-85-5
Molecular Formula :
C₁₀H₁₆N₂O₃S
Product Description
| Molecular weight | 244.31 |
|---|---|
| Molecular formula | C10H16N2O3S |
| CAS No. | 58-85-5 |
Quality Control
| Appearance (USP) | Practically white, crystalline powder |
|---|---|
| Appearance (EP, BP) | White or almost white, crystalline powder or colourless crystals |
| Appearance (JP) | White crystals or a white crystalline powder |
| Solubility (EP, BP) | Very slightly soluble in water and in ethanol (96%), practically insoluble in acetone. It dissolves in dilute solutions of alkali hydroxides |
| Solubility (USP) | Very slightly soluble in water and in alcohol; insoluble in other common organic solvent |
| Solubility (JP) | Very slightly soluble in water and in ethanol (99.5%); it dissolves in dilute sodium hydroxide TS |
| Identification A, FTIR : (EP, BP, USP) | Matches with the standard pattern |
| Identification (JP) | Matches with the standard pattern |
| Identification B, TLC : (EP, BP) | The principal spot in the chromatogram obtained with test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution |
| Identification B (USP) | It meets the requirements for specific rotation test |
| Identification C (USP) | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay |
| Appearance of solution (EP, BP) | 1% solution in 4 g/L solution of sodium hydroxide R is clear and colourless |
| Clarity and color of solution (JP) | 10% solution in 0.5 mol/L sodium hydroxide TS is clear and colourless |
| Melting point (JP) | ~231°C (dec.) |
| Specific rotation (EP, BP) | +89.00° to +93.00° (c= 1% in 4g/L solution of sodium hydroxide R at 20 ± 0.5°C, dried substance) |
| Specific rotation (USP) | +89.00° to +93.00° (c= 2% in 0.1N sodium hydroxide, at 25°C) |
| Specific rotation (JP) | +89.00° to +93.00° (c= 2% in dilute sodium hydroxide TS, at 20°C) |
| Related substances, TLC (JP) | The spots other than the principal spot obtained from the sample solution are not more intense than the spot obtained from the standard solution |
| Related substances, system suitability, HPLC : Resolution, (EP, BP) | >= 1.50 between the peaks due to biotin and impurity A |
| Related substances, impurity A for each impurity, HPLC: (EP, BP) | <= 0.50% |
| Related substances, impurity E for each impurity, HPLC: (EP, BP) | <= 0.50% |
| Related substances, impurity C, HPLC : (EP, BP) | <= 0.20% |
| Related substances, unspecified impurities for each impurity, HPLC : (EP, BP) | <= 0.10% |
| Related substances, total impurities, HPLC : (EP, BP) | <= 2.00% |
| Heavy metals (JP) | <= 0.0010% |
| Arsenic (JP) | <= 0.00028% |
| Loss on drying (at 105°C, constant weight) : (EP, BP) | <= 1.00% |
| Loss on drying (at 105°C, 4hr) : (JP) | <= 0.50% |
| Sulfated ash (EP, BP) | <= 0.10% |
| Residue on ignition (JP) | <= 0.10% |
| Related compounds and assay 1, system suitability, HPLC: tailing factor, USP | <= 1.50 |
| Related compounds and assay 2, system suitability, HPLC : RSD, USP | <= 2.00% |
| Related compounds, individual impurity, HPLC : (USP) | <= 1.00% |
| Related compounds, total impurities, HPLC : (USP) | <= 2.00% |
| Assay (HPLC): (USP) | 97.50 - 102.00% |
| Assay (TBAH Titration, dried substance) : (EP, BP) | 98.50 - 101.00% |
| Assay (HCl Titration, dried basis) : (JP) | 98.50 - 101.00% |
Storage and Shelf Life
| Store at | 2 - 8°C away from bright light. |
|---|---|
| Shelf life | 36 months. |
| Use | before expiry date given on the product label. |
CAS Number :
58-85-5
Molecular Formula :
C₁₀H₁₆N₂O₃S
| Product Name | D-Biotin |
|---|---|
| SKU | TC096M |
| CAS No | 58-85-5 |
| Molecular formula | C₁₀H₁₆N₂O₃S |
| Molecular Weight | 244.31 |
| Storage | 2 - 8°C |
| Shelf Life | 3 Years |
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