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Doxycycline Hcl

Doxycycline Hcl
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Product name: Doxycycline HCL





1.Formular: C22H25CIN2O8





2.CAS #: 10592-13-9





3.Purity: 99% min



 



CERTIFICATE OF ANALYSIS



 


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CAS號(hào): 10592-13-9

分子式: C22H25ClN2O8

10592-13-9

英文名稱: Doxycycline HCl

英文同義詞: Doxycycline Hydrochloride Anhydrous; Doxycycline Hydrochloride; (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride; (1S,3Z,4aS,11R,11aR,12S,12aR)-3-[amino(hydroxy)methylidene]-4a,6,7,12-tetrahydroxy-N,N,11-trimethyl-2,4,5-trioxo-1,2,3,4,4a,5,11,11a,12,12a-decahydrotetracen-1-aminium chloride; (2Z,4S,4aR,5S,5aR,6R)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2H,4H,5H)-trione hydrochloride; 4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

EINECS號(hào): 234-198-7

分子量: 480.8955

 

Product name: Doxycycline HCL


1.Formular: C22H25CIN2O8


2.CAS #: 10592-13-9


3.Purity: 99% min

 

CERTIFICATE OF ANALYSIS

 

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)

 

 

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