&

^s+,

Certificateof Analysis

rE[t

DOXYCYCLINEHYCLATE

\\IZZ

Batch Number
Packing Size
Quantity

1209100 Test Date

25ks.
Manufacture Date
500kg
Expiration Date

TEST

SPECIFICATON

$ep.26.2012
Seo.2012
Aug.2016

Appearance

Yellowcrystalline
powder.

RESUXT
Corresponds

Identification

A) tnofHPLCtest
B) Sulphuricacidyellow Colorreaction

Corresponds

c)

Chloride'sreaction

pH

2.0to 3.0

2.5

Specific OpticalRotation

-105" to -120" ,calculatedonthe

anhydrous,
ethanol-fieesubstance.

-112'

SpecificAbsorbance

300-335at349nnr,calculatedon
theanhydrom,ethanol-freezubstance

325

Not More Than0.07at 490nnLcalculatedon

theanhydrous,
ethanol-free
substance

0.03

Light-absorbingImpurities

RelatedSubstances
Metacycline
6-epidoxycycline
Any individualimpurities
Disregardlimit

NotMoreThan2.0%
NotMoreThan2.0%
NotMoreThar05%
NotMoreThan0.l%

Ethanol

4.3 to 6.0%

IleavyMetals

LessThan50ppm

<50ppm

Wafer

l.4Yoto2.8%o

r.9%

SulphatedAsh

NotMoreThan0.4%

Assay

95.0- 102.0o/o
of CzzFIzsClNzOs,
calculatedon the
anhydrous,
elhaaoLfteosh$ane.e.*

fi-,,,
lEdl{NlEffffi*ifi

Conforms

4.906

<0.t%
983%

lffi&+ffi:r,.
Conclusion
Caution:

Th.AbooffistoBp2oo7

This materialcannot be shippedto US market

ManufacturedBy: Kunshanchemical& pharmaceuticalco. . Ltd

Version:2.0