Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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L-Isoleucine
SKU:
TC049M
CAS Number :
73-32-5
Molecular Formula :
C₆H₁₃NO₂
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Product Identifier
| Product Name | L-Isoleucine (From non-animal source) Meets USP-NF, EP, BP and JP testing specifications |
|---|---|
| Product Code | TC049M |
| Molecular weight | 131.17 |
| Molecular formula | C6H13NO2 |
| CAS No. | 73-32-5 |
Technical Specification
| Appearance (USP) | White crystals |
|---|---|
| Appearance (JP) | White crystals or a crystalline powder |
| Appearance (EP, BP) | White or almost white, crystalline powder or flakes |
| Solubility (USP) | Soluble in water; slightly soluble in hot alcohol, insoluble in ether |
| Solubility (EP, BP) | Sparingly soluble in water, slightly soluble in ethanol (96%). It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. |
| Solubility (JP) | Freely soluble in formic acid, sparingly soluble in water, and practically insoluble in ethanol (95). It dissolves in dilute hydrochloric acid |
| Identification A : FTIR (USP) | Matches with the standard pattern |
| Identification A : Specific optical rotation (EP, BP) | +40.00° to +43.00° (c = 4% in hydrochloric acid R1 at 20 ± 0.5°C, dried substance) |
| Identification : FTIR (JP) | Matches with the standard pattern |
| Identification B : FTIR (EP, BP) | Matches with the standard pattern |
| Identification C : 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 (EP, BP) | The solution of 0.5 g in 10 mL of 103 g/L solution of HCl is clear and not more intensely coloured than reference solution BY6 |
| Clarity and color of solution (JP) | 5% solution in 1M HCl is clear and colourless |
| pH (1% in water) : (USP) | 5.50 - 7.00 |
| pH (1% in water) : (JP) | 5.50 - 6.50 |
| Specific rotation (USP) | +38.90° to +41.80° (c = 4% in 6N HCl at 25°C) |
| Specific rotation (EP, BP) | +40.00° to +43.00° (c = 4% in hydrochloric acid R1 at 20 ± 0.5°C, dried substance) |
| Specific rotation (JP) | +39.50° to +41.50° (c = 4% in 6M HCl at 20°C, after drying) |
| Chloride (USP) | <= 0.05% |
| Chloride (JP) | <= 0.021% |
| Chloride (EP, BP) | <= 0.02% |
| Sulfate (USP) | <= 0.03% |
| Sulfate (EP, BP) | <= 0.03% |
| Sulfate (JP) | <= 0.028% |
| Iron (USP) | <= 0.0030% |
| Iron (EP, BP) | <= 0.0010% |
| Heavy metals (USP) | <= 0.0015% |
| Heavy metals (JP) | <= 0.0020% |
| Ammonium (JP) | <= 0.020% |
| Arsenic (JP) | <= 0.00020% |
| Loss on drying (USP, JP) | <= 0.30% (at 105°C, 3 hr) |
| Loss on drying (EP, BP) | <= 0.50% (at 105°C, till constant weight) |
| Sulfated ash (EP, BP) | <= 0.10% |
| Residue on ignition (USP) | <= 0.30% |
| Residue on ignition (JP) | <= 0.10% |
| Related compounds, System suitability requirements : TLC (USP) | The chromatogram of the system suitability solution exhibits two clearly separated spots |
| Related compounds, acceptance criteria: TLC (USP) | Any secondary spot of the sample solution is not larger or more intense than the principal spot of the standard solution |
| Related compounds, Individual impurity: TLC (USP) | <= 0.50% |
| Related compounds, Total impurities : TLC (USP) | <= 2.00% |
| Related substances : TLC (JP) | The spot other than the principal spot obtained from the sample solution is not more intense than the spot obtained from the standard solution. |
| Ninhydrin-positive substances 1: System suitability: Resolution, Amino acid analysis : (EP, BP) | min. 1.5 between the peaks due to and isoleucine and impurity C |
| Ninhydrin-positive substances 2: Impurities A and C at 570 nm, for each impurity, Amino acid analysis : (EP, BP) | <= 0.30% |
| Ninhydrin-positive substances 3: Each impurity, Amino acid analysis : (EP, BP) | <= 0.20% |
| Ninhydrin-positive substances 4: Total impurities, Amino acid analysis: (EP, BP) | <= 1.00% |
| Ammonium, Amino acid analysis : (EP, BP) | <= 0.020% (at 570 nm) |
| Assay (NT, dried basis) : (USP) | 98.50 - 101.50% |
| Assay (NT, dried substance) : (EP, BP) | 98.50 - 101.00% |
| Assay (NT, dried substance) : (JP) | min. 98.50% |
| Storage | Store below 30°C away from bright light. |
| Shelf life | 48 months. |
| Use before expiry date | given on the product label. |
CAS Number :
73-32-5
Molecular Formula :
C₆H₁₃NO₂
| Product Name | L-Isoleucine |
|---|---|
| SKU | TC049M |
| CAS No | 73-32-5 |
| EC No. | 200-798-2 |
| Molecular formula | C₆H₁₃NO₂ |
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