Manufacturer high quality DOCOSAHEXAENOIC ACID

Items

Specifications

Results

Appearance

White to off-white powder

White powder

Solubility

Freely soluble in dichloromethane and acetone; 

soluble in methanol and trichloromethane;

 slightly soluble in water

Complies

Identification

(1) IR

Sample IR spectrum corresponds to that of the standards

Complies

(2) HPLC

The retention time of the major peak of the sample solution 

corresponds to

 that of the standard solution, as obtained in the assay

Complies

Test

Triazole acetophenone: ≤0.12%

Not detected

Ethyl fluropyrimidine: ≤0.12%

0.10%

Voriconazole related compound A: ≤0.12%

Not detected

Related substance

(RR,SS)6- Chlorovoriconazole: ≤0.12%

0.09%

6- Chlorovoriconazole: ≤0.12%

0.09%

Any unspecified impurity: ≤0.1%

0.08%

Total impurities:≤0.5%

0.40%

Heavy Metal

NMT 10ppm

<10ppm

Residue on ignition

NMT 0.1%

0.06%

Enantiomeric purity

Voriconazole related compound B: ≤0.12%

Not detected

Loss on Drying

NMT 0.5%

0.04%

Trichloromethane

NMT 60ppm

Not detected

Dichloromethane

NMT 600ppm

Not detected

Methanol

NMT 3000ppm

Not detected

2-propanol

NMT 5000ppm

200ppm

Acetone

NMT 5000ppm

Not detected

Assay( on dried basis )

98.0%~102.0%

99.40%

Conclusion

Complies with the specification