CEFDINIR CEFDINIR CEPHDINIR
1. ISO AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
Item |
Acceptance Criteria |
Result |
Appearance |
White to light yellow crystalline powder |
Light yellow crystalline powder |
Identification (IR) |
Complies |
Complies |
Particle size distribution D(0.1/0.5/0.9)um |
Informative |
5.7/113.2/187.8 um |
pH |
2.6 ~4.1 |
3.1 |
Water (K.F.) |
9.0% ~ 12.0% |
10.8% |
Sulphated ash |
≤0.2% |
0.04 |
Assay |
95.0% ~102.0%(on anhydrous substance) |
100.6% |
Related substances |
|
|
Impurity A |
≤0.5% |
0.06% |
Impurity B |
≤0.5% |
N.D. |
Impurity C |
≤0.5% |
0.05% |
Impurity D |
≤0.5% |
0.03% |
Impurity E |
≤0.5% |
0.11% |
Impurity F |
≤0.5% |
N.D. |
Any unspecified impurity |
≤0.10% |
0.03% |
Total |
≤3.0% |
0.22% |
Residual solvent- Acetone |
≤0.5% |
0.20% |
Microbial enumeration testes |
|
|
Total aerobic microbial count (TAMC) |
≤103 cfu/g |
0 |
Total combined yeasts/molds count (TYMC) |
≤102 cfu/g |
0 |
Conclusion |
Conforms to EP |
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