Shanghai Fine Chemicals

API • Vitamins • Food ingredients
Veterinary Injection & Premix

Neomycin Sulfate

Items of Test Limits of Test Results of Test
1.Appearance Orange yellow crystalline powder Meets
2.Identification A: Optical rotation -115o to -135o B: TLC test C: Test of fluorescence A: Value B,C: Meets
3.Acidity or Alkalinity check the color of the test solution after adding the respective solutions Meets
4.Lumiflavin TLC NMT 0.025% Meets
5.Absorbance 0.31-0.33A373nm/A267nm 0.36-0.39A444nm/A267nm Meets
6.Particla Size 100% passes through 80 mesh sieve Meets
7.Specific Rotation between-115o and -135o (EP/BP/USP) -124o
8.Loss on Drying ≤1.5% 0.5%
9.Heavy Metals <10ppm Meets
10.Residue on Ignition ≤0.3% (USP) ≤0.1%(EP/BP) 0.1%
11.Organic Volatile Impurities Method IV <467> (USP) Meets
12.Assay(ondried basis) 98.0%-102.0% (USP) 97.0%-103.0% (EP/BP) 98.4%

testig itemsspecificationresult
Colour Yellow-orange to yellow-brown Meets
Odour weak to none Meets
Particle structure fine spray-dried granules Meets
Identification Positive Meets
Particle size 60 U.S mesh(MIN.90% PASSED) Meets
Residue on Ignition Max.5% 3%
Humidity Max.3.0% 1.9%
Content(Activity) Min.80.0% (by HPLC Method) 80.5%