1. |
Description |
White or faintly yellow crystals or a crystalline powder. |
2. |
Identification |
A. Determine by Infrared absorption spectrophotometry |
B. Determine by Chemical test |
C. Determine by Chemical test |
D. Determine by Chemical test |
3. |
Appearance of Solution |
Solution is clear and less intensely coloured than Ref. Sol. BYS7 |
4. |
pH |
7.0 to 8.0 |
5. |
Specific Optical Rotation |
+103° to +108° |
6. |
Heavy Metals |
NMT 20 ppm |
7. |
Loss on Drying |
NMT 0.25% |
8. |
Assay |
99.0% to 101.0% |
9. |
Total Aerobic Microbial Count |
Not more than 1000 CFU/g |
10. |
Total Yeast and Mold Count |
Not more than 100 CFU/g |
11. |
Escherichia coli |
Absent/g |
12. |
Salmonella |
Absent/10 gm |