Plot No. C40, Road No. 21Y, MIDC, Wagle Industrial Estate, Thane(W)-400604, MH, India
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Protamine sulphate
SKU:
TC563M
CAS Number :
9009-65-8
Availability: In stock
Only %1 left
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$447.90
Product Identifier
| Product Name | Protamine sulphate |
|---|---|
| Product Code | TC563M |
| CAS | 9009-65-8 |
Technical Specification
| Appearance (JP) | White powder |
|---|---|
| Appearance (EP, BP, IP) | White or almost white hygroscopic powder |
| Solubility (IP) | Sparingly soluble in water, practically insoluble in chloroform, ethanol (95%) and in ether |
| Solubility (EP, BP) | Sparingly soluble in water, practically insoluble in ethanol (96%) |
| Solubility (JP) | Sparingly soluble in water |
| Identification A (USP) | The retention times of the four major peaks of the sample solution corresponds to, those of the standard solution as obtained in the assay |
| Identification A : (IP) | Produces a precipitate under the condition of Assay |
| Identification A : Specific optical rotation (BP) | -85.00° to -65.00° (c = 1% in 0.1M HCl at 20°C, dried substance) |
| Identification A : Protamine peptide A content, HPLC (EP) | 13-18% |
| Identification A : Protamine peptide B content, HPLC (EP) | 21-28% |
| Identification A : Protamine peptide C content, HPLC (EP) | 31-38% |
| Identification A : Protamine peptide D content, HPLC (EP) | 19-24% |
| Identification 1 : (JP) | A vivid red colour develops |
| Identification B: (USP) | Reactions for sulphate |
| Identification B : (IP) | An intense red colour is produced |
| Identification B : (BP) | Protamine sulphate forms a precipitate |
| Identification B : (EP) | It gives the appropriate response when examined as described in the potency assay |
| Identification 2 : (JP) | A red purple colour develops |
| Identification C: Bioidentity: (USP) | Each mg of protamine sulphate neutralizes >= 100 USP Heparin Units on the dried basis |
| Identification C: (BP) | An intense red colour is produced |
| Identification C: (EP) | It complies with the tests for sulphate |
| Identification C: (IP) | A white precipitate is produced |
| Identification 3 : (JP) | Reactions for sulphates |
| Identification D (IP) | Reactions for sulfate |
| Identification D (BP) | A precipitate is formed |
| Identification E (BP) | Reactions for sulfate |
| Appearance of solution (EP, BP) | The solution is not more opalescent than reference suspension II (2.2.1) and not more intensely coloured than reference solution BY6 or Y6 (2.2.2, Method II) |
| Appearance of solution (IP) | The resulting solution is not more opalescent than opalescent standard OS2(2.4.1) and not more intensely coloured than reference solution BY6S6 (2.4.1) |
| Clarity and colour of solution (JP) | 1% solution in water is clear and colourless |
| pH (1% in water at 25°C) : (JP) | 6.50-7.50 |
| Specific rotation (BP, IP) | -85.00° to -65.00° (c = 1% in 0.1M HCl at 20°C, dried substance) |
| Sulphate (USP, JP) | 16 -22% (dried substance) |
| Sulphate (IP, EP, BP) | 16 -24% (dried substance) |
| Iron (USP, EP, BP) | <= 0.001% |
| Iron (IP) | <= 0.002% |
| Light absorption (IP) | <= 0.1 (at 260 to 280nm) |
| Absorbance (USP, EP, BP, JP) | <= 0.1 (at 260 to 280nm) |
| Methyl mercury (USP) | <= 0.001% |
| Mercury (BP, IP) | <= 0.001% |
| Heavy metals (IP) | <= 0.002% |
| Loss on drying (USP, EP, BP, JP, IP) | <= 5.0% (at 105°C, 3 hr) |
| Residual solvent: (USP) | Meets the requirements |
| Nitrogen, dried substance : (BP, IP) | 21.00 - 26.00% |
| Nitrogen, dried substance : (JP) | 22.50 - 25.50% |
| Related substances : System suitability : Resolution: HPLC (EP) | >= 2.0 |
| Related substances : HPLC (EP) | <= 8.0% |
| Heparin-binding capacity : System suitability : RSD, sample solution A, B, C : UV (JP) | <= 5.0% |
| Heparin-binding capacity : System suitability : RSD, Set of A, B, C : UV (JP) | <= 5.0% |
| Heparin binding capacity : UV : (JP) | min. 100 Units/mg of heparin, dried basis |
| Assay: Standard deviation : Colorimetry (BP) | <= 5.0% |
| Assay: Standard deviation of each test solution : UV (IP) | <= 5.0% |
| Assay: RSD: HPLC (USP) | <= 2.0% |
| Assay: resolution : HPLC (USP) | >= 2.0 |
| Potency (USP, EP) | min. 100 IU of heparin, dried basis |
| Chromatographic purity : (USP) | min. 92.00% |
| Assay (HPLC, dried substance) : (USP, EP) | 90.00 - 110.00% |
| Assay: colorimetry: (BP) | min. 100 IU of heparin, dried basis |
| Assay: UV: (IP) | min. 100 Units of heparin sodium RS, dried basis |
| Bacterial endotoxin : (USP, IP) | <= 7.0 USP endotoxin Units/mg |
| Bacterial endotoxin : (BP) | <= 7.0 IU/mg |
Storage and Shelf Life
| Storage | Store below 30°C away from bright light. |
|---|---|
| Shelf life | 48 months. |
| Use | Use before expiry date given on the product label. |
CAS Number :
9009-65-8
| Product Name | Protamine sulphate |
|---|---|
| SKU | TC563M |
| CAS No | 9009-65-8 |
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