From: Subject: TYPICAL CERTIFICATE OF ANALYSIS Date: Mon, 15 Feb 2010 10:51:25 +0530 MIME-Version: 1.0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: file://D:\Sangita\Typical%20COA%20of%20Albendazole.htm X-MimeOLE: Produced By Microsoft MimeOLE V5.00.2615.200 TYPICAL CERTIFICATE OF ANALYSIS

TYPICAL=20 CERTIFICATE OF ANALYSIS=20

ALBENDAZOLE=20 USP =9231

Sr.=20 No. Test

 Specification

 Observation

1. Appearance

 White=20 to Pale buff colored / Yellow powder. Amorphous = powder. White=20 to Pale buff colored/ Yellow powder. Amorphous = powder.
2. Solubility

Practically=20 insoluble in water;

And=20 in Alcohol.=20 Very=20 slightly soluble in Ether and in Methylene = Chloride.

Freely=20 soluble in Formic Acid.

 Complies
3. Identification [IR]

The IR spectrum of the sample  should be concordent = with the=20 standard spectrum of the

Albendazole  = W.S.

 Complies
4. Melting Point

 Melt=20 at about 208=B0C=20 To 210=B0C Complies
5. Loss on=20 drying

Dry=20 at 105=BAC For 4 Hrs ; NMT 0.5% w/w. 0.35%
6. Heavy Metals

 Not=20 more than 0.002% (20 ppm) Complies
7.

Residue on=20 ignition

(Sulphated Ash)

NMT:=20 0.20% 0.13%
8. Chromatography Purity

(Related=20 Substances )

(BY TLC)

As per=20 USP=9231

Single=20 Impurity : NMT =20 0.75%=20 Total=20 Impurities : NMT 1.50%

 Complies
9. Assay

 NLT=20 98.0% and NMT =20 102.0% 99.40%w/w
10. Particle size

 90%=20 < 75 Microns Complies
11.=20

 

 Residual solvent

 

i)  = Methanol

ii) =20 Acetic acid

iii) =20 N,N,DMF

  

 

NMT: 3000=20 PPM

NMT: 5000 PPM

NMT: 5000 PPM

 Complies
Report  In=20 the opinion of the =20 undersigned, the sample referred to above is of standard = quality,=20   

 as=20 defined in the Act & Rules Made there under of = USP=9231.=20