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Manufacturer
& Exporter of Binding Agent, Lubricants, Solublisers, Coatings,
Disintegrant & Super Disintegrant. |
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| Parameters | Specification | Result |
| Description | Very Fine, White or off White, Free flowing Powder, Odourless or almost odourless. | Fine, White, Odourless powder |
| Solubility | Practically Insoluble in water Insoluble in most organic solvents. | Complies |
| Identification | ||
| A | Infra-red absorption spectrum should concordant with IP reference standards | Concord with IP reference (IR spectrum is enclosed) |
| B | Should comply | Complies |
| C | Should comply | Complies |
| pH | 5.5 to 7.5 | 6.4 |
| Loss on Drying% | NMT 10 | 6.6 |
| Iron% | NMT 0.002 | Passes |
| Heavy Metal | NMT 0.002 | Passes |
| Sodium Chloride% | NMT 10 | 6.7 |
| Assay, as Sodium% | 2.8 to 4.5 | 3.1 |
| Sodium Glycollate% | NMT 2 | Passes |
| Swelling volume ml* | NLT 40 | 50 |
| .. Microbiological Analysis | ||
| Parameters | Specifications | Result |
| *Total Aerobic Microbial Count, CFU/g | NMT 1000 | 200 |
| *Total Yeast and Mould Count, CFU/g | NMT 100 | <10 |
| Escherichia coli, per 1 g | Absent | Absent |
| Salmonella sp. per 1 g | Absent | Absent |
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