| A | POWDERS | CODE | APPLICATION |
|---|---|---|---|
| 1 | Powder | P 101 | Granulation for Tablets |
| 2 | Fine Powder | P 102 | Liquid Syrup |
| B | COARSE POWDERS | ||
| 1 | Dense | P 201 | Granulation for Tablets |
| 2 | High Dense | P 202 | Capsule Grade |
| 3 | Free Flowing | P 203 | Encapsulation Grade |
| C | ANY TAILOR MADE SPECIFICATION | ||
| D | BATCH SIZE |
4 MT TO 8 MT -helps reduce In-House Laboratory Work |
| Test No. | Name of Test | IP | BP/EP | USP |
|---|---|---|---|---|
| 1. | Description/Appearance | White Crystals or White Crystalline Powder | White, or almost white, Crystalline Powder | White, odorless, Crystalline Powder. |
| 2. | Solubility | Sparingly soluble in Water | Sparingly soluble in Water | - |
| Freely soluble in ethanol | Freely soluble in Ethanol (96%) | Freely soluble in Ethyl Alcohol | ||
| Very slight soluble in Methylene chloride | Very slight soluble in Methylene chloride | - | ||
| - | - | Soluble in Boiling Water and in 1N NaOH. | ||
| 3. | Melting Point | - | - | - |
| 4. | Identification | (A) The absorbance at 249 nm is about 0.44 (B) A violet color develops which does not turn to red. (C) Gives the reaction of acetyl groups. (D) The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Paracetamol working standard. |
(A)Result-A Melting Point - 168°C to 172°C. Result-B The absolute difference between the melting point mixture and the value obtained in Determination A (Result-A) is not greater than 2°C (B) The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Paracetamol working standard. |
(A)By IR: The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Acetaminophen working standard. (B) By HPLC: The retention time of the major peak obtained in sample solution corresponds to that obtained in the standard solution, as described in the test of assay. |
| Related Substance | ||||
| Impurity J | Max. 10 ppm | Max. 10 ppm | - | |
| Impurity K | Max. 50 ppm | Max. 50 ppm | - | |
| Impurity F | Max. 0.05 % | - | - | |
| Unspecified Impurity | - | Max. 0.05 % | Max. 0.05 % | |
| Total Impurities | Max. 0.1 % | Max. 0.2 % | NMT 0.1 % | |
| Any other Impurity | Max. 0.05 % | - | - | |
| Organic Impurities | ||||
| Acetaminophen Related Compound B | - | - | NMT 0.05% | |
| Acetaminophen Related Compound C | - | - | NMT 0.05% | |
| Acetaminophen Related Compound B | - | - | NMT 0.05% | |
| Acetaminophen Related Compound J | - | - | NMT 0.001% | |
| 5. | Free 4-Aminophenol | - | - | NMT 0.005% |
| 6. | Loss on Drying (at 105°C) | Maximum 0.5% w/w | Maximum 0.5 % w/w | Maximum 0.5% w/w |
| 7. | Residue on Ignition | - | - | NMT 0.1% |
| 8. | Heavy Metals | NMT 10 ppm | - | - |
| 9. | Sulphated Ash | NMT 0.1 % w/w | NMT 0.1 % w/w | - |
| 10. | Assay | 99.0 % to 101.0 % w/w C8H9NO2 (On dried basis) | 99.0 % to 101.0 % w/w C8H9NO2 (On dried basis) | 98.0% - 102.0%, (C8H9NO2 on the dried basis) |
