Product Name: Oxytetracycline Hydrochloride (INJECTABLE, NON-STERILE )

Expiry Date:3 YEARS

Tests

Specification

Characteristics

Yellow crystalline powder

Identification

B. Examine the chromatograms obtained in the test for related substances

 C: REACTION WITH SULPHURIC ACID

D:REACTION OF CHLORIDES

pH

2.3 ~ 2.9

Light absorbing impurities

(430nm)≤0.50

(490nm) ≤0.20

RELATED SUBSTANCES:

Impurity A

Impurity B

Impurity C

Impurity D

Impurity E

Any other impurty

Total impurities

≤0.5%

≤1.0%

≤2.0%

≤0.2%

≤0.2%

≤0.1%

≤3.5%

Residual solvents

Methanol ≤3000ppm

Sulfated ash

≤0.2%

Water

≤2.0%

BACTERIAL ENDOTOXINS

≤0.4EU/mg

TAMC

≤1000CFU/g

TYMC

≤100CFU/g

E.coli

ABSENCE IN 1g

ASSAY (ANHYDROUS SUBSTANCE) contant of  C22H25ClN2O9

94.5% TO 102.0%

RESULT AND CONCLUSION: Complies with Ph.Eur.9.0