Product:

Oxytetracycline Hcl

Batch No.

080016

Quantity:

1000kgs

Mfg. date:

Feb.20, 2008

Expiry date:

Feb.20, 2012

test item

BP2007

USP29

specification

result

specification

result

Characters

A yellow crystalline powder

A yellow crystalline powder

Yellow odorles
Crystalline powder

Yellow odorles
Crystalline powder

Identification

According to BP2007

Complies

A:Absorptivity:88.2~96.8%
B: Positive

91.5%
Positive

Crystallinity

NA

NA

Meet the requirement

Complies

PH

Between 2.3and2.9

2.46

Between 2.0and3.0

2.46

Loss on drying

NA

NA

NMT2.0%

0.8%

Specificopticalrotation

-188-188°- -200°

-188.3°

NA

NA

Absorbance

270-290

271.5

NA

NA

Light –absorbing impurities

430nm: NMT0.5
490nm: NMT0.2

0.30
0.03

NA

NA

Heavy metals

NMT 50ppm

Complies

NA

NA

Related substances

Content of impurity peak Meets the requirements

Complies

NA

NA

Sulfated ash

Not more than 0.5%

0.08

NA

NA

Water

Not more than 2.0%

0.84

NA

NA

Potency

NA

NA

NLT 835 ug/mg
(anhydrous)

897 ug/mg (anhydrous)

890 ug/mg

Assay(HPLC)

95.0-102.0%
anhydrous

97.1

NA

NA