Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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N-Acetyl-L-Cysteine
SKU:
TC054M
CAS Number :
616-91-1
Molecular Formula :
C₅H₉NO₃S
Availability: In stock
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Product Identifier
| Product Name | N-Acetyl-L-Cysteine (From non-animal source) |
|---|---|
| Product Code | TC054M |
| Molecular weight | 163.191 |
| Molecular formula | C5H9NO3S |
| CAS No. | 616-91-1 |
| Shelf life | 48 months |
Technical Specification
| Appearance (USP) | White crystalline powder |
|---|---|
| Appearance (EP, BP) | White or almost white crystalline powder or colourless crystals |
| Appearance (JP) | White crystals or crystalline powder |
| Solubility (USP) | Freely soluble in water and in alcohol; practically insoluble in chloroform and in ether |
| Solubility (EP, BP) | Freely soluble in water and in ethanol (96%); practically insoluble in methylene chloride |
| Solubility (JP) | It is freely soluble in water and in ethanol (99.5%). It dissolves in sodium hydroxide solution |
| Identification: FTIR (JP) | Matches with the standard pattern |
| Identification A : FTIR (USP) | Matches with the standard pattern |
| Identification C : FTIR (EP, BP) | Matches with the standard pattern |
| Specific rotation (USP, EP, BP, JP) | +21.0° to +27.0° (mix 1.25 gm with 1 mL of 10 g/L sodium edetate R. Add 7.5 mL of a 40 g/L solution of sodium hydroxide R, mix and dissolve. Dilute to 25.0 mL with phosphate buffer solution pH 7.0 R2 |
| Identification D : HPLC (EP, BP) | The principal spot in the chromatogram obtained with test solution (b) is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (b) |
| Identification E (EP, BP) | An dark violet colour develops |
| pH (1% in water at 25°C) (USP, EP, BP) | 2.00-2.80 |
| Appearance of the solution (EP, BP) | 5% solution in water is clear and colourless |
| Melting range (EP, BP) | 104 - 110°C |
| Melting range (JP) | 107-111°C |
| Heavy metals (USP, EP, JP) | <= 0.001% |
| Zinc (EP, BP) | <= 0.001% |
| Ammonium (JP) | <= 0.02% |
| Chloride (JP) | <= 0.040% |
| Iron (JP) | <= 0.001% |
| Sulphate (JP) | <= 0.030% |
| Loss on drying (JP) | <= 0.50% (at 80°C, 3 hr) |
| Loss on drying (USP) | <= 1.0% (about 50mm of mercury at 70°C, 4 hr) |
| Loss on drying (EP, BP) | <= 1.0% (over P2O5, 1.5 kPa to 2.5 kPa at 70°C, 3 hr) |
| Residue on ignition (JP) | <= 0.30% |
| Residue on ignition (USP) | <= 0.50% |
| Sulfated ash (EP, BP) | <= 0.20% |
| Related substances : system suitability: RSD : HPLC (JP) | <= 2.0% |
| Related substances : any other impurities : HPLC (JP) | <= 0.3% |
| Related substances : Total impurities : HPLC (JP) | <= 0.6% |
| Related substance : system suitability : resolution 1: HPLC (EP, BP) | >= 1.5 between the peaks due to impurities A and B |
| Related substance : system suitability : resolution 2: HPLC (EP, BP) | >= 2.0 between the peaks due to impurities C and D |
| Related substances : impurities A, B, C,D : for each impurity: HPLC (EP, BP) | <= 0.50% |
| Related substance : any other impurity : for each impurity : HPLC (EP,BP) | <= 0.50% |
| Related substance: Total impurities: HPLC (EP, BP) | <= 0.50% |
| System suitability : Resolution : HPLC (USP) | >= 6.0 between acetylcysteine and L-phenylalanine |
| System suitability : RSD : HPLC (USP) | <= 2.0% |
| Assay (HPLC, dried basis) : (USP) | 98.00 - 102.00% |
| Assay (Iodimetry, dried substance) : (EP, BP) | 98.00 - 101.00% |
| Assay (Iodometry, dried basis) : (JP) | 99.00 - 101.00% |
| Storage | Store at 2 to 8°C |
CAS Number :
616-91-1
Molecular Formula :
C₅H₉NO₃S
| Product Name | N-Acetyl-L-Cysteine |
|---|---|
| SKU | TC054M |
| CAS No | 616-91-1 |
| EC No. | 210-498-3 |
| Molecular formula | C₅H₉NO₃S |
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