Gentamycin sulfate
CAS No.: 1405-41-0
Product Name: Gentamycin sulfate
CAS#1405-41-0
Spec: EP
Package: 24kg/drum
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
CAS#1405-41-0
Spec: EP
Package: 24kg/drum
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
Description
Spec of Gentamycin sulfate :
| Items | Specification | Results | |
| Characters | White or almost white, hygroscopic powder.Freely soluble in water, practically insoluble in ethanol(96percent) | White hygroscopic powder Solubility:Complies | |
| Specific optical rotation | +107°~+121° | +117° | |
| Identification | B)The chromatogram obtained with the test solution shows 5 principal peak having the same retention times as the 5 principal peaks in the chromatogram obtained with reference solution | Complies | |
| C)it gives reaction (a) of sulfates | Positive | ||
| PH | 3.5-5.5 | 5.1 | |
| Appearance of solution | Clarity | Clear | 7 |
| Colour | Not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour. | ||
| Methanol | Maximum 1.0 % | NA | |
| Sulfated ash | Maximum 1.0 % | 0.3% | |
| Sulfate(anhydrous) | 32.0 % -35.0 % | 32.7% | |
| Water | Maximum15.0% | 9.7% | |
| Composition(HPLC) | C1: 25.0%-45.0%% | 32.6% | |
| C1a: 10.0%-30.0% | 23.0% | ||
| C2a+C2+C2b: 35.0%-55.0% | 44.4% | ||
| Related Substances | Impurities A: Max 3.0% | 0.4% | |
| Impurities B: Max 3.0% | 0.1% | ||
| Any other impurity: Max 3.0% | Not detected | ||
| Total: Max 10.0% | 0.5% | ||
| Assay | 2590 IU/mg (anhydrous ) | 6321U/mg (as is) | |
| 700 IU/mg (anhydrous ) | |||
| Visible foreign matter (internal) | Visible foreign matter should be absent, comply with requirement if tiny visible matter detected | Complies | |
| Microbiological Contamination (internal): |
TAMC cfu /g 10³ TYMC cfu /g 10² E.Coli /g absent |
31cfu/g 15cfu/g Absent |
|
