PHARMA EXCIPIENTS
| Property | Specifications | Analysis |
| 1. Appearance at 25 C | White to creamy white powder | Passes |
| 2. Reaction with Potassium dichromate | Positive | Passes |
| 3.Reactionwith Cobaltnitrate and Ammonium thiocyanate | Positive | Passes |
| 4. Reaction with iodine | Positive | Passes |
| 5. Moisture | 5% max | 0.16% |
| 6. pH | 3.0-7.0 | 3.21 |
| 7. Residue on ignition | 0.1% max. | 0.04% |
| 8. Vinyl pyrrolidone | 10 ppm max. | 1.31 ppm |
| 9. K-value | 27-34 | 33.02 |
| 10. Hydrazine | < 1 ppm | <1 ppm |
| 11. Nitrogen | 11.5% - 12.8% | 11.88% |
| 12. Heavy metals | 10 ppm max. | <10 ppm |
| 13.
Aldehydes ( Calculated as Acetaldehyde ) |
500 ppm max. | 330 ppm |
|
Crospovidone USP/BP/EP |
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| TEST | SPECIFICATION | TEST RESULT |
| Appearance | A White to Yellowish White Powder | White Powder |
| Solubility | Insoluble in water, in alcohol & methylene chloride | Insoluble in water, in alcohol & methylene chloride |
| Identification A+B+C | Positive | Complies |
| Peroxides | 400 ppm max | Complies |
| Water Soluble substance | 1.5% max | 0.17% |
| Impurity A | 0.1% max | 0.001% |
| Heavy metals | 0.001% max | Complies |
| Loss of Drying | 5% max | 3.5% |
| Residue on ignition | 0.4% max | 0.04% |
| Nitrogen content | 11.0-12.8% | 12.1% |
|
PVP K (Polyvinyl Pyrrolidone K-17/K-25/K-30/K-90) |
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| Grade | Packing | |||
| Tech/ Cosmetics | 50 Kg. fibre drums | |||
|
Specifications |
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| Grade | K-17 | K-25 | K-30 | K-90 |
| K Value | 13-20 | 22-28 | 27-33 | 80-100 |
| V. Pyrrolidone | 0.2%max | 0.2%max | 0.2%max | 0.2%max |
| Ash | 0.02%max | 0.02%max | 0.02%max | 0.02%max |
| pH | 5-7 | 3-7 | 3-7 | 3-7 |
| Water | 5.0%max | 5.0%max | 5.0%max | 5.0%max |
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NOTE: K-17 -The appearance of this shall be slightly yellowish because of low K value. |
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