| CAS No.: | 131707-23-8 |
|---|---|
| Formula: | C22h26brcln2o3s |
| EINECS: | 680-680-9 |
| Type: | Pharmaceutical Intermediates |
| Appearance: | Powder |
| Colour: | White |
| Customization: |
|---|
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Audited Supplier | Items | Methods | Standards | Result |
| Appearance | Visual | From white to white with a greenish-yellowish or brownish shade crystalline powder | Conforms |
| Identification | IR-spectroscopy The State Pharmacopoeia (XII ed.) |
IR spectrum of the substance according to the position of absorption bands should correspond to the applied IR spectrum | Conforms |
| Spectrophotometry The State Pharmacopoeia (XII ed.) |
UV spectrum of absorption of 0,001 % substance solution in the field of wavelength from 210 nm to 380 nm must have max. of absorption at (225 ±2) nm , (255± 2) nm and (316 ± 2) nm and min. of absorption at (244±2) nm and (284±2) nm | Conforms | |
| Qualitative reactions: -for bromides (A) -for sulfates -for chlorides |
In accordance with the State Pharmacopoeia (XI ed.); In accordance with the State Pharmacopoeia (XI ed.); In accordance with the State Pharmacopoeia (XI ed.) |
Conforms | |
| Related impurities | HPLC The State Pharmacopoeia (XII ed.) |
Total summary - not more than 0.5 % |
0.4% |
| Sulphated ash | The State Pharmacopoeia (XI ed.) |
Not more than 0.1 % | 0.05% |
| Heavy metals | The State Pharmacopoeia (XI ed.) |
Not more than 0.001 % | 0.0009% |
| Water | The State Pharmacopoeia (XI ed.). Karl Fischer method |
From 3.0 to 4.0 % | 3.7% |
| Microbiological quality | The State Pharmacopoeia (XI ed., Amendment No 3) |
Category 2.2 | Conforms |
| Assay | Titrimetry The State Pharmacopoeia (XII ed.) |
From 99.0 to 101.0 %C22H2sBrN2O3S HCl calculated on anhydrous substance |
99.7% |
| Conclusion | Conforms to PSF JICP-005206/07-241207 (LSR-005206/07-241207), Amendment No 1 | ||
| Packaging | 1 kg, 5 kg, 10 kg, 25 kg in a double package of polyethylene film. Each package is placed in a corrugated cardboard box or in a cardboard convolute drum or a polyethylene barrel. Each package is provided with a label | ||
| Labelling | In accordance with Product Specification File (PSF) | ||
| Storage | List B. Protect from light in a dry place at a temperature not exceeding 25ºC | ||
The End |
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