Doxycycline Hcl

DESCRIPTION OF GOODS

Doxycycline Hyclate

BATCH NO.

K9-020

MANUFACTURING DATE

FEB.03.2009

EXPIRY DATE

Jan.2013

QUANTITY

1001kgs

COUNTRY OF ORIGIN

CHINA

NAME OF INDEX

INDEX

ANALYSIS VALUE

Characteristics

A yellow crystalline powder

Comply

Solubility

Complies to PH.Eur.6.0

Comply

Identification

A.B.C.Positive reaction

Comply

p.h

2.0-3.0

2.4

Absorbance (349 nm)

300-335

321

Specific optical rotation

-105~-120°

-116°

Heavy metals

≤50ppm

<50ppm

Light—absorbing impurities(490nm)

≤0.07

0.02

Impurity A
Impurity B

Impurity C

Impurity D

Impurity E

Impurity F

Any other impurity

≤2.0%
≤2.0%

≤0.5%

≤0.5%

≤0.5%

≤0.5%

≤0.5%

≤0.10

Comply

Ethanol

4.3- 6.0%

4.6%

Sulphated ash

≤0.4%

0.03%

Water

1.4-2.8%

2.0%

Microbial limit

Total aerobic microbial count≤1000CFU/g
Total yeast and mold count ≤100CFU/g
E.Coli Not detected

Comply

Assay: 95.0%--102.0% of Doxycycline hydrochloride (C₂₂H₂₅CIN₂O₈). calculated with reference to the anhydrous, ethanol-free substance.

97.5%

CONCLUSION: Complies with Ph.Eur.6.0 .   (NO.RO-CEP 2001-038-Rev01)