CAS # 109887-53-8
H. S. NO. 29333990
END USE: PAROXETINE HCL
Molecular Formula: C13H18FNO
Molecular Wt.: 223.29
| Sr. No. | Test | Standard Specification |
| 01 | Appearance | White to Yellowish crystalline Powder. |
| 02 | Melting Point | Between 96°C to 102°C. |
| 03 | Loss on Drying | Not More Than 0.50%. |
| 04 | Specific rotation (at 20°C +2°C) | Between -34°C to -38°. |
| 05 | Assay by HPLC | Not Less Than 98.0%. |
| 06 | Chromatographic Purity | Not Less Than 98.0%. |
| 07 | Related Substance by HPLC | |
| Known Impurity 1 | Not More Than 0.10%. | |
| Known Impurity 2 | Not More Than 0.5%. | |
| Any Other Individual unknown impurity |
Not More Than 0.5%. | |
| Total Impurities | Not More Than 2.0%. | |
| 08 | Content of (4) Enantiomer | Not More Than 0.7%. |
| Remarks: The above-referred product NPP-5 complies as per In-house Specifications. Storage condition: Store in a tightly closed container at a room temperature. |
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CAS # 50910-55-9
H. S. NO. 29223900
END USE: AMBROXOL HCL
Molecular Formula: C7H5Br2NO
Molecular Wt.: 278.93
| Sr. No. | Test | Standard Specification |
| 01 | Description | Yellow coloured crystalline powder. |
| 02 | Solubility | Sparingly soluble in chloroform i.e. 2.0%w/v solution in chloroform must be clear. |
| 03 | Identification | |
| By HPLC | In the test of assay Retention time of the principal peak in sample preparation should be corresponds to that peak of the standard preparation. | |
| 04 | Melting point | Between 137 to 140°C. |
| 05 | Loss on drying @105°C | Not more than 0.5%, |
| 06 | Related Substance by HPLC | |
| 2-amino-3,5 dibromo benzoic acid | Not more than 0.10% | |
| 2-amino-3,5 dibromo benzyl alcohol | Not more than 0.10% | |
| Each unspecified impurity | Not more than 0.10% | |
| Total Impurities | Not more than 0.50% | |
| 07 | Purity by HPLC | Not Less Than 99.50% |
| 08 | Assay by HPLC (OAB) | 98.0 to 102.0% |
| Remarks: The above-referred product 2-amino 3,5-Dibromo benzaldehyde (NPP-9) complies as per In-house Specifications. Storage condition: Store in a tightly closed container. | ||
CAS # 79560-19-3
H. S. NUMBER: 29269095
END USE: SERTRALINE HCL
Molecular Formula: C6H12Cl2O
Molecular Wt.: 291.17
| Sr. No. | Test | Standard Specification |
| 01 | Description | A white to off white crystalline powder. |
| 02 | Solubility | Slightly soluble in water |
| 03 | Identification Infrared absorption | |
| By IR | The IR spectrum of sample must be concordant with spectrum of the working standard. | |
| By HPLC | In the test of assay retention time of the principal peak in sample preparation should be corresponds to that peak of the standard preparation. | |
| 04 | Melting Point | About 100°C. |
| 05 | Loss on drving 70°C | Not more than 0.5%. |
| 06 | Related substances by HPLC | |
| 2,3-Dichloro isomer of This email address is being protected from spambots. You need JavaScript enabled to view it. RRT | Not more than 0.10% | |
| Unspecified impurities (any single) | Not more than 0.10% | |
| Total Impurities | Not more than 0.50% | |
| 07 | Sulphated Ash | Not more than 0.10% |
| 08 | Purity by HPLC | Not less than 99.50% |
| 09 | Assay by HPLC | 99.0 to 102.0% on dried basis |
| 10 | Residual solvent | |
| Methanol | Not More than 3000 ppm | |
| Acetone | Not more than 5000 ppm | |
| 1,2 Dichlorobenzene | Not more than 360 ppm | |
| Remarks: The above referred product NPP-14 complies as per in-house Specifications. Storage condition: Store in tightly closed container at Room Temperature |
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