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QUININE HCL - DFI-578676
Published: 02/05/2019Description
| Appearance | White or almost white or colourless, fine, silky needles, often in clusters, soluble in water, freely soluble in ethanol (96%) |
| Appearance of solution | Solution S is clear and not more intensley coloured than reference solution Y6 |
| Shelf life | 60 Months |
| Country of Manufacture | India |
Specification
| Identification(A, B, C, D, E) | Conforms |
| pH | 6 to 6.8 |
| Specific Rotation | 245 to 258° |
| Dihydroquinine(impurity C) | <=10% |
| Eluted before Quinine(Any impurity) | <=5% |
| Impurities(Any other) | Max:2.5% |
| Sulphate | Max:500ppm |
| Barium | Passes |
| Loss on drying | 6 to 10% |
| Sulphated ash | Max:0.1% |
| Assay | 99 to 101% |
Microbiological
| Bacterial Count | <=1000cfu/g |
| Yeasts & Moulds | <=100cfu/g |
| Escherichia Coli | Absent in 10g |
| Salmonella | Absent in 10g |
| Pseudomonas aeruginosa | Absent in 10g |
| Staphylococcus aureus | Absent in 10g |
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