- E-mail : info@wellonapharma.com
- Call : +91-261-2571244
- Mob: +91-7490041245
Treatment of infections of lower respiratory tract including pneumonia, urinary tract, skin and skin structures, bone and joints; treatment of bacteremia/septicemia, CNS infections, intra-abdominal infections including peritonitis, gynecological infections including pelvic inflammatory disease.
Specification:
|
Items |
Specification |
Analysis Result |
|
|
Appearance |
White to light yellow crystalline powder |
Conform |
|
|
Identification |
1. The retention times of the major peaks in the chromatogram of the assay preparation correspond to those of the Standard preparation obtained in the assay |
Conform |
|
|
2. The IR absorption spectrum of the substance to be examined corresponds to that of the reference standard. |
Conform |
||
|
Specific Rotation |
-75°~-88° |
-84° |
|
|
Crystallinity |
Meets the USP test requirements |
Conform |
|
|
PH |
2.6~4.1 |
3.6 |
|
|
Water Content |
9.0%~12.0% |
10.4 |
|
|
Residue of ignition |
Not more than 0.1% |
Conform |
|
|
Heavy Metals |
Not more than 20ppm |
Conform |
|
|
Chromatographic purity |
Meets the USP test requirements |
Conform |
|
|
Assay (anhydrous) |
95.0%~103.0% |
99.8% |
|
|
Related Impurities |
Individual impurities |
Not more than1.00% |
0.30% |
|
Total impurities |
Not more than2.00% |
0.80% |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
