TEST

SPECIFICATION

RESULTS

1. Characters

Yellow crystalline powder, hygroscopic freely soluble in water. Solution in water become to turbid on standing, owing to the precipitation of oxytetracycline.

complies

2. Identification

a) TLC results

b) Color reaction with sulfuric acid

c) Color reaction with silver nitrate

Positive

Positive

Positive

3. PH

2.3 to 2.9

2.50

4. Specific optical rotation

-188o to -200o (anhydrous substance)

-189.1o

5. Specific absorbance at 353nm

270 to 290(anhydrous substance)

280.9

6. Light-absorbing impurities

a) At 430nm≤0.50 (anhydrous substance)

b)At 490nm≤0.20(anhydrous substance)

0.127

0.046

7. Related substances

a) 4-Eploxytetracycline≤0.5%

0.28%

b) Tetracycline hydrochloride ≤2.0%

0.73%

c) Total mixture of α,β-Apo-oxytetracycline≤2.0%

0.82%

d) Peak on the tail of the main peak≤2.0%

0.1%

8. Sulphated ash

≤0.5%

0.08%

9. Water

≤2.0%

0.92%

10. Heavy metals

≤50ppm

Complies

11. Assay

Between 95.0% and 102.0% on anhydrous basis

97.2%

12. Particle size

≤0.3%

0.2%

Storage: Store in airtight container, protected from light

Conclusion: This product fulfils Ph Eur6.0 / BP2007