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Amphotericin B 1397-89-3 Amphotericin B 1397-89-3

Amphotericin B 1397-89-3
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Basic information of Amphotericin B

Name

Amphotericin B

Alias

Fungizone;Amphotericin B injectable grade non sterile

CAS NO.

1397-89-3

Molecular Formula

C47H73NO17

Molecular Weight

924.07902

Quality Standard

USP /≥750μg/mg

Grade Standard

Medicine grade

Package Size

500g/tin or 1kg/tin

Use of Amphotericin B


  • Amphotericin B is an antifungal drug often used intravenously for systemic fungal infections. It is the only effective treatment for some fungal infections
  • Common side effects may include: a reaction which may include fever, headaches and low blood pressure among other symptoms rapidly after it is given, and kidney problems. Allergic symptoms including anaphylaxis may occur.


COA of Amphotericin B

TESTS

SPECIFICATIONS

RESULTS

Appearance

Yellow to orange powder. No visible                          evidence of contamination by foreign matter

Yellow Powder

Identification A:(UV)

Conforms to standard, absorbance in the range of 240nm to 320nm

conforms

Identification B:(UV/Vis)

Conforms to standard, absorbancein the range of 320nm to 400nm

Conforms

Identification C:IR

Conforms to the reference standard

Conforms

Identification D:(Color)

passes test

conforms

Loss on drying

Not more than 5.0%

1.1%

Absorbance Ration:

362/381=0.57 to 0.61

381/405=0.87 to 0.93

0.60

0.88

Residue on Ignition:

Not more than 0.5%

0.2%

Solubility:

Passes test

Conforms

Amphotericin A:

Not more than 5% calculated on the dried basis

Not detected


Related Substances:

Amphotericin BMethylester

Any Individual unknown

Total Unknown impurities

Total Impurities


Not more than 2.0%


Not more than 2.0%

Not morethan 7.0%

Not more than 9.0%


0.3%


1.2%

3.1%

3.4%

Assay( Microbial)

Not less than 840ug/mg calculated on the dried basis

1094ug/mg

Assay( HPLC)

Not less than 90% on an anhydrous weight basis

114%


Microbial limits:

Total Aerobic count

Salmonella species

Eschenchia Coli


Not more than 100CFU/ gram

Negative

Negative


0CFU/gram

Conforms

Conforms

Bacterial endotoxins

Not more than 1EU/mg

Conforms

Residual Solvents:

Ethanol

DMF

Acetone


Not more than 5000ppm

Not more than 6000ppm

Not more than 5000ppm


2902ppm

3390ppm

2966ppm

Conclusion

Conforms with USP30


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MORE_DETAIL Amphotericin B 1397-89-3

Basic information of Amphotericin B

Name

Amphotericin B

Alias

Fungizone;Amphotericin B injectable grade non sterile

CAS NO.

1397-89-3

Molecular Formula

C47H73NO17

Molecular Weight

924.07902

Quality Standard

USP /≥750μg/mg

Grade Standard

Medicine grade

Package Size

500g/tin or 1kg/tin

Use of Amphotericin B


  • Amphotericin B is an antifungal drug often used intravenously for systemic fungal infections. It is the only effective treatment for some fungal infections
  • Common side effects may include: a reaction which may include fever, headaches and low blood pressure among other symptoms rapidly after it is given, and kidney problems. Allergic symptoms including anaphylaxis may occur.


COA of Amphotericin B

TESTS

SPECIFICATIONS

RESULTS

Appearance

Yellow to orange powder. No visible                          evidence of contamination by foreign matter

Yellow Powder

Identification A:(UV)

Conforms to standard, absorbance in the range of 240nm to 320nm

conforms

Identification B:(UV/Vis)

Conforms to standard, absorbancein the range of 320nm to 400nm

Conforms

Identification C:IR

Conforms to the reference standard

Conforms

Identification D:(Color)

passes test

conforms

Loss on drying

Not more than 5.0%

1.1%

Absorbance Ration:

362/381=0.57 to 0.61

381/405=0.87 to 0.93

0.60

0.88

Residue on Ignition:

Not more than 0.5%

0.2%

Solubility:

Passes test

Conforms

Amphotericin A:

Not more than 5% calculated on the dried basis

Not detected


Related Substances:

Amphotericin BMethylester

Any Individual unknown

Total Unknown impurities

Total Impurities


Not more than 2.0%


Not more than 2.0%

Not morethan 7.0%

Not more than 9.0%


0.3%


1.2%

3.1%

3.4%

Assay( Microbial)

Not less than 840ug/mg calculated on the dried basis

1094ug/mg

Assay( HPLC)

Not less than 90% on an anhydrous weight basis

114%


Microbial limits:

Total Aerobic count

Salmonella species

Eschenchia Coli


Not more than 100CFU/ gram

Negative

Negative


0CFU/gram

Conforms

Conforms

Bacterial endotoxins

Not more than 1EU/mg

Conforms

Residual Solvents:

Ethanol

DMF

Acetone


Not more than 5000ppm

Not more than 6000ppm

Not more than 5000ppm


2902ppm

3390ppm

2966ppm

Conclusion

Conforms with USP30

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