Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
Your enquiry has been submitted
Something problem with the server. Try again.
Methotrexate
SKU:
TC762M
CAS Number :
59-05-2
Molecular Formula :
C₂₀H₂₂N₈O₅
Availability: In stock
Only %1 left
$0.00
Product Description :
| Molecular weight | 454.44 |
|---|---|
| Molecular formula | C20H22N8O5 |
| CAS No. | 59-05-2 |
Quality Control:
| Appearance (USP) | Orange-brown, or yellow, crystalline powder |
|---|---|
| Appearance (IP) | A yellow to orange-brown, crystalline powder |
| Appearance (EP, BP) | Yellow or orange, crystalline, hygroscopic powder |
| Appearance (JP) | Yellow-brown crystalline powder |
| Solubility (USP) | Freely soluble in dilute solutions of alkali hydroxides and carbonates; slightly soluble in 6N hydrochloric acid; practically insoluble in water, in alcohol, in chloroform, and in ether |
| Solubility (IP) | Practically insoluble in water, 1,2-dichloroethane, in ethanol (95%) and in ether. It dissolves in dilute solutions of mineral acids and in dilute solutions of alkali hydroxides and in carbonates |
| Solubility (EP, ВР) | Practically insoluble in water, in ethanol (96%) and in methylene chloride. It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides and carbonates |
| Solubility (JP) | It is slightly soluble in pyridine, and practically insoluble in water, in acetonitrile, in ethanol (95%) and in diethyl ether. It dissolves in dilute sodium hydroxide TS and in dilute sodium carbonate TS. |
| Identification A, FTIR : (USP) | Matches with the standard pattern |
| Identification, FTIR (EP, BP) | Matches with the standard pattern |
| Identification A, FTIR: (IP) | Matches with the standard pattern |
| Identification 1, UV : (JP) | Both spectra exhibit similar intensities of absorption at the same wavelengths. |
| Identification B, UV : (USP) | Meets the requirement |
| Identification B, UV : (IP) | Complies |
| Identification 2, FTIR : (JP) | Matches with the standard pattern |
| Residue on ignition : (USP, JP) | <= 0.10% |
| Sulfated ash: (EP, BP, IP) | <= 0.10% |
| Water: (USP, IP, JP) | <= 12.00% |
| Water: (EP, BP) | <= 13.00% |
| Organic impurities 1, Procedure 1, Related compounds, HPLC : system suitability, resolution (USP) | >= 1.7 between methotrexate related compound B and methotrexate related compound C |
| Organic impurities 2, Procedure 1, Related compounds, HPLC : system suitability, resolution (USP) | >= 10.0 between methotrexate related compound C and methotrexate |
| Organic impurities 3, Procedure 1, Related compounds, HPLC : system suitability, resolution (USP) | >= 5.0 between methotrexate related compound I and methotrexate related compound H |
| Organic impurities 4, Procedure 1, Related compounds, HPLC : system suitability, RSD (USP) | <= 5.00%, standard solution A |
| Organic impurities 5, Procedure 1, Related compounds, HPLC : individual impurities, Methotrexate related compound Bª (USP) | <= 0.30% |
| Organic impurities 6, Procedure 1, Related compounds, HPLC : individual impurities, Methotrexate related compound C (USP) | <= 0.50% |
| Organic impurities 7, Procedure 1, Related compounds, HPLC : individual impurities, Methotrexate related compound E free base (USP) | <= 0.30% |
| Organic impurities 8, Procedure 1, Related compounds, HPLC: individual impurities, Methotrexate dimethylamidea and methotrexate related compound Ib (USP) | <= 0.20% |
| Organic impurities 9, Procedure 1, Related compounds, HPLC : individual impurities, Methotrexate related compound Hd | <= 0.20% |
| Organic impurities 10, Procedure 1, Related compounds, HPLC : individual impurities, any unspecified impurity (USP) | <= 0.10% |
| Organic impurities 11, Procedure 1, Related compounds, HPLC : total impurities (USP) | <= 1.00% |
| Organic impurities 1, Procedure 2, enantiomeric purity, HPLC: system suitability, resolution (USP) | >= 1.30 between methotrexate and R-methotrexate |
| Organic impurities 2, Procedure 2, enantiomeric purity, HPLC: system suitability, RSD (USP) | <= 5.00% for the methotrexate peak |
| Organic impurities 3, Procedure 3, enantiomeric purity, HPLC: (USP) | <= 3.00% |
| Related substances and assay 1, system suitability, HPLC: resolution (EP, BP) | min. 2.0 between the peaks due to impurities B and C |
| Related substances and assay 2, system system suitability, HPLC : resolution (EP, BP) | min. 1.5 between the peaks due to impurity D and methotrexate, in the chromatogram obtained with reference solution (d) |
| Related substances and assay 3, system suitability, HPLC: resolution (EP, BP) | min. 1.5 between the peaks due to impurities I and H in the chromatogram obtained with reference solution (e) |
| Related substances, impurity C, HPLC : (EP, BP) | <= 0.50% |
| Related substances, impurity B and E, for each impurity, HPLC : (EP, BP) | <= 0.30% |
| Related substances, impurity H and I, for each impurity, HPLC: (EP, BP) | <= 0.20% |
| Related substances, unspecified impurities, for each impurity, HPLC : (EP, ВР) | <= 0.05% |
| Related substances, sum of impurities other than B, C and E, HPLC : (EP, ВР) | <= 0.50% |
| Enantiomeric purity : system suitability resolution, HPLC (EP, BP) | >= 2.00 between the peaks due to methotrexate and impurity F |
| Enantiomeric purity : Impurity F, HPLC (ЕР, ВР) | <= 3.00% |
| Related substances, system suitability 1, resolution, HPLC (IP) | min. 2.0 between the peaks due to methotrexate impurities B and C |
| Related substances, system suitability 2, resolution, HPLC (IP) | min. 1.5 between the peaks due to methotrexate impurity D and methotrexate |
| Related substances, impurity C, HPLC : (IP) | <= 0.50% |
| Related substances, methotrexate impurities B and E, HPLC : (IP) | <= 0.30% |
| Related substances, methotrexate impurities H and I, HPLC : (IP) | <= 0.20% |
| Related substances, any other secondary peak, HPLC : (IP) | <= 0.05% |
| Related substances, sum of areas of all secondary peaks other than methotrexate impurities B, C and E, HPLC (IP) | <= 0.50% |
| Enantiomeric purity : system suitability resolution, HPLC (IP) | >= 2.00 between the peaks due to methotrexate and impurity F |
| Enantiomeric purity: Impurity F, HPLC (IP) | <= 3.00% |
| Assay, system suitability : tailing factor, HPLC (USP) | <= 1.60 |
| Assay, system suitability : relative standard deviation, HPLC (USP) | <= 2.00% |
| Assay (HPLC, on anhydrous basis) : (USP) | 98.00 - 102.00% |
| Assay (HPLC, on anhydrous basis) : (EP, BP) | 97.00 - 102.00% |
| Assay, system suitability, HPLC : RSD (IP) | <= 2.00% |
| Assay, system suitability : resolution, HPLC (IP) | >= 5.00 between the peaks due to methotrexate and folic acid |
| Assay (HPLC, anhydrous basis) : (IP) | 97.00 - 102.00% |
| Assay, system performance : Resolution, HPLC (JP) | >= 8.00 between the peaks due to folic acid and methotrexate |
| Assay, system repeatability : RSD, HPLC (JP) | <= 1.00% |
| Assay (HPLC, on anhydrous basis) : (JP) | 94.00 - 102.00% |
Storage and Shelf Life:
| Storage | 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 :
59-05-2
Molecular Formula :
C₂₀H₂₂N₈O₅
| Product Name | Methotrexate |
|---|---|
| SKU | TC762M |
| CAS No | 59-05-2 |
| EC No. | 200-413-8 |
| Molecular formula | C₂₀H₂₂N₈O₅ |
Write Your Own Review