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Quick Details

  • CAS No.: 86386-73-4 |
  • Place of Origin: Andhra Pradesh, India
  • Type: Other
  • Grade Standard: Other
  • Purity: 99.0%

Packaging & Delivery

Packaging Details packing 25 kg with HDPE drums
Delivery Time prompt

Specifications

we are largest exports of Fluconazole with the following specification . For more details please contact us cell:9989522441

CERTIFICATE OF ANALYSIS

Name of the Product

Fluconazole  USP

Batch No.             

201111008

Date of Mfg.        

Nov’2011

Date of Exp.

Oct 2014

RESULTS  OF  ANALYSIS

Sr. No.

TESTS

SPECIFICATIONS

RESULTS

1.

Description

White or almost white crystalline powder

White crystalline powder

2.

Solubility                 

Freely soluble in water and in methanol, very slightly soluble in acetone

Complies

3.

Clarity and colour of solution

Solution is to be clear and colorless

Complies

4.

Identification

             a) IR  Absorption

 

To be concordant with working standard.

 

Complies

5.

Loss on drying 

NMT 0.50 %

0.18 %

6.

Residue on ignition

NMT 0.10%

0.03 %

7.

Iron 

NMT 0.002 %

Complies

8.

Melting Range

138.0 to 142.0OC

139.2 to 140.5OC

       

8.

Related Compounds

 

 

 

Impurity at RRT 0.6

NMT 1.00%

0.15%

 

Related Compound  A

NMT 0.20%

0.11%

 

Related Compound  B

NMT 0.10%

Not detected

 

Related Compound  C

NMT 0.20%

0.02%

 

Any other individual Impurity

NMT 0.10%

0.03%

 

Total unknown impurities

NMT 0.30%

0.01%

 

Total Impurities

NMT 1.50%

0.32%

9.

Assay (on dried basis)

98.00 % to 102.00 %

99.62 %

11

Bulk Density

Not Less than 0.55%

0.55%

12

Tapped density

Not Less than 0.50%

0.89%

13

Partical Size

Less than 45µm

Complies

14

Dispersion in water (5%)

Must be free from any foreign particles

Comples

 

          Remarks: complies as per USP-32    specification with respect to the above test.  

 

Authorised Signatory

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