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Tobramycine Base USP

Product Name: Tobramycine Base USP

CAS No.: 32986-56-4

CAS NO: 32986-56-4

Molecular Formula: C18H37N5O9

Properties: White or almost white powder, hygroscopic

Usage: As an amino glycoside antibiotic, it has high activity against gram-negative bacilli

Package:

Storage:  Keep containers closed and stored in cool and well ventilated places

Product Standard: USP 

 

SPECIFICATION:

ITEMS

STANDARDS

Appearance

White or almost white

powder, hygroscopic

Identification

a. Conforms with

Reference Standard Rf.

(TLC)

b. Conforms with

Reference Standard

Retention time. (HPLC)

pH

9.0~ 11.0

Water

≤7.5 %

Residue on ignition

≤1.0%

Heavy metals

≤0.003%

Organic impurities (TLC)

≤1.0%

Assay (on anhydrous basis)

≥910µg/mg

Bacterial endotoxins

   < 2EU/mg

Clarity and Color

Clear, ≤3# yellow or yellow

green standard solution

Residual solvent

Ethanol

≤2000ppm

Benzene

≤2 ppm

Microbial limits

Total Aerobic Microbial Count

≤103cfu/g

Total Yeasts and Molds Count

≤102cfu/g

Escherichia coli

Absent(1g)

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