| Items of Test | Limits of Test | Results of Test |
| 1.Appearance | Orange yellow crystalline powder | Meets |
| 2.Identification | A: Optical rotation -115o to -135o B: TLC test C: Test of fluorescence | A: Value B,C: Meets |
| 3.Acidity or Alkalinity | check the color of the test solution after adding the respective solutions | Meets |
| 4.Lumiflavin | TLC NMT 0.025% | Meets |
| 5.Absorbance | 0.31-0.33A373nm/A267nm 0.36-0.39A444nm/A267nm | Meets |
| 6.Particla Size | 100% passes through 80 mesh sieve | Meets |
| 7.Specific Rotation | between-115o and -135o (EP/BP/USP) | -124o |
| 8.Loss on Drying | ≤1.5% | 0.5% |
| 9.Heavy Metals | <10ppm | Meets |
| 10.Residue on Ignition | ≤0.3% (USP) ≤0.1%(EP/BP) | 0.1% |
| 11.Organic Volatile Impurities | Method IV <467> (USP) | Meets |
| 12.Assay(ondried basis) | 98.0%-102.0% (USP) 97.0%-103.0% (EP/BP) | 98.4% |
| testig itemsspecificationresult | ||
| Colour | Yellow-orange to yellow-brown | Meets |
| Odour | weak to none | Meets |
| Particle structure | fine spray-dried granules | Meets |
| Identification | Positive | Meets |
| Particle size | 60 U.S mesh(MIN.90% PASSED) | Meets |
| Residue on Ignition | Max.5% | 3% |
| Humidity | Max.3.0% | 1.9% |
| Content(Activity) | Min.80.0% (by HPLC Method) | 80.5% |
| CONCLUSION: THIS PRODUCT FULFILS THE STANDARDS. | ||