8/18/2019 1-Doxycyline Hyclate BP

1/1

&

^s+,

E[t

\\IZZ

Certificate

of

Analysis

1209100 Test Date

25ks.

Manufacture

Date

500kg

Expiration

Date

SPECIFICATON

DOXYCYCLINE

HYCLATE

Batch Number

Packing

Size

Quantity

TEST

Appearance

Identification

pH

Specifi

Optical

Rotation

SpecificAbsorbance

Light-absorbing

mpurities

Related

Substances

Metacycline

6-epidoxycycline

Any

individual

mpurities

Disregard

imit

Ethanol

IleavyMetals

Wafer

SulphatedAsh

Assay

A)

B)

c)

Yellow

rystallineowder.

tnofHPLCtest

Sulphuric

cid

yellow

Color

eaction

Chloride's

eaction

2.0

o

3.0

-105

to

-120

,calculatedonthe

anhydrous,

thanol-fiee

ubstance.

300-335at

49nnr,

alculated

n

theanhydrom,

thanol-free

ubstance

Not More

Than

0.07

at 490nnL

alculated

n

the

anhydrous,

thanol-free

ubstance

NotMoreThan2.0%

NotMoreThan2.0%

NotMoreThar05%

NotMoreThan0.l%

4.3

to

6.0%

Less

Than

50ppm

l.4Yoto2.8%o

NotMoreThan0.4%

95.0

102.0o/o

f

CzzFIzsClNzOs,

alculated

n he

anhydrous,

lhaaoLfteosh$ane.e.*

lEdl{NlEffffi*ifi

i-,,

lffi&+ffi:r,.

Th.AbooffistoBp2oo7

$ep.26.2012

Seo.2012

Aug.2016

RESUXT

Corresponds

Corresponds

-112'

325

0.03

Conforms

4.906