Varieties: | Other |
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Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
Customization: |
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Item | Specification | Test Results | Testing methods |
Appearance | Dark red, crystals or crystalline powder | Complies | Monograph:0547 Visual method |
Identifiction A | UV:Absorption maxima at 274±1nm,351±1nm and 525±2nm.274±1nm,351±1nm,525±2nm | Complies | Ph.Eur.monograph Ph.Eur. <2.2.25> |
A274nm/A351nm: 0.75~0.83 A525nm/A351nm: 0.31~0.35 |
0.79 0.33 |
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Identifiction B |
TLC:The principal spot in the chromatogram obtained with the test solution is similar in position,colour and size to the principal spot in the chromatogram obtained with the reference solution |
Complies |
Ph.Eur.monograph Ph.Eur. <2.2.27> |
Identifiction C | Chlorides:It gives reaction(a) of chlorides | Complies | Ph.Eur.monograph<2.3.1>Chlorides |
Loss on drying | 8.0%~12.0% | 8.4% | Ph.Eur.monograph Ph.Eur<2.2.32> |
Assay | 96.0%~102.0% | 98.8% | Ph.Eur.monograph Ph.Eur<2.2.25> |
Related substances | ≤5% | 2% | Ph.Eur.monograph/ Ph.Eur<2.2.29>(HPLC) |
Acetone | ≤5000ppm | 22ppm | In house/(GC) (GC)SOP-QC-158-04-03 |
Total aerobic microbial count | ≤1000cfu/g | <10cfu/g | ChP 2015<1105> |
The total combined yeasts/mould count |
≤100cfu/g | <10cfu/g |
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