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Quick Details

  • CAS No.: 83881-52-1 -
  • Place of Origin: Andhra Pradesh, India
  • Type: Other
  • Grade Standard: Other
  • Purity: 99.0%

Packaging & Delivery

Packaging Details packing 25 kgs with HDPE drums
Delivery Time prompt

Specifications

We are largest exporters of Cetrizine di Hydrochloride with following specification.For more details please contact us.

CERTIFICATE OF ANALYSIS

 

Product Name  :  CETRIZINE DI HYDROCHLORIDE E.P

 

Batch No          :  CZ/001/09/12

 

Batch Qty         :  250.0 Kg                                                                   Mfg  Dt :  SEP-2012

 

                                                                                                             Exp  Dt :  AUG-2015

 

S.No

 

TEST

 

SPECIFICATION

 

RESULT

 

1

Description

A white or almost white  powder

White powder

 

2

Solubility

Freely insoluble in water, practically  insoluble in acetone and in methylene chloride

Complies

 

3.

Identification

Absorption

Complies

Thin-layer chromatography

Complies

It gives reaction (a) of Chlorides

Complies

4

Appearance of solution

 

5% solution is clear and not more intensely colored than reference solution BY7

Complies

 

5

 

Loss of drying

 

Note more than 0.5% w/w

0.40% w/w

 

6

 

pH (5% w/v solution )

 

Between 1.2 to 1.8

1.7

 

7

 

Heavy metals

 

Not more than 10ppm

Less than 10ppm

   

    8

 

 

Related substances by HPLC

Single maximum unknown

 

impurity: NMT 0.1%

0.08%

 

Total impurities: NMT 0.3%

0.17%

 

    9

Sulphated Ash

Not more than 0.2%

0.02%

 

 

   10

Assay on dry basis

99.7% to 100.5%

100.4%

 

 

 

 

 

 

 

       

Remarks: The above material Complies with above   specifications.                      

 

 

         Authorised signatory  

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