CERTIFICATE OF ANALYSIS

Name of product::

Oxytetracycline HCL

According to:

BP2005

Batch No.:

Y1-0803192-1

RESULTS OF ANALYSIS TESTS AS FOLLOWS:

ANALYSIS ITEM

QUALITY INDEXES

RESULTS

Description

Yellow crystalline powder

Confirm

Indentification

a)TLC results

b)colour reaction with sulphuric acid

c)reaction of chlorides

Positive

Positive

Positive  

PH value(1% w/v)

2.3∼2.9

2.32

Absobance at 353nm(PH 2.0)

270∼290

277.5

Specific optical rotation

-188∼-200

-193.6

Heavy metals

<50ppm

<25

Light absorbing impurities

<0.50(430nm)

< 0.20(490nm)

0.32

0.06

Related substance

Impurity A

Impurity B

Impurity C

Impurity D,E and F

<0.5%

<2.0%

<2.0%

<2.0%

0.2%

0.2%

1.46%

0.55%

Sulphated Ash

<0.5%

0.09%

Water content

<2.0%

0.29%

Assay(caulated on anhydrous product)

95%∼120%

95.3%

Conclusion

This product complies with BP2005