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

0.31-0.33  A373nm/A267nm

0.36-0.39  A444nm/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 items                 specification       result                                  

  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%

CONCLUSION: THIS PRODUCT FULFILS THE STANDARDS.