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Molekula Amphotericin B - Injection grade (22793495)

Chemical Name: Amphotericin B

Certifications & Compliance: EU Compliant, REACH (Europe), United States Pharmacopeia (USP)

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Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
1397-89-3
EC No.
215-742-2
Molecular Structure

Molekula Amphotericin B - Injection grade (22793495) - Molecular Structure

Applications & Uses

Properties

Physical Form
Appearance
Yellow or orange powder
Typical Properties
ValueUnitsTest Method / Conditions
Molecular Weight924.079
Microbiological Values
ValueUnitsTest Method / Conditions
Bacterial endotoxinsmax. 1IU/mg
Escherichia coliNegative
SalmonellaNegative/10g
Total Aerobic Count100cfu/g
Specifications
ValueUnitsTest Method / Conditions
Acetonemax. 5000ppm
Amphoterecin Amax. 5%Dried Basis
Amphoterecin B Methyl estermax. 2%
Any Other Impuritymax. 2%
Assay (Microbial)min. 840IU/mgDried Basis
Assay Contentmin. 90%HPLC Method
DMFmax. 6000ppm
Ethanol Contentmax. 5000ppm
Loss on Dryingmax. 5%
Residue on Ignitionmax. 0.5%
SolubilityPasses test
Total Impuritiesmax. 9.0%
Total Unknown Impuritiesmax. 7%

Regulatory & Compliance

Safety & Health

Hazard Statements
  • H315 : Causes skin irritation
  • H319 : Causes serious eye irritation
  • H335 : May cause respiratory irritation
Precautionary Statements
  • P261 : Avoid breathing dust/fume/gas/mist/vapors/spray
  • P305+351+338 : IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do, continue rinsing

Storage & Handling

Storage Temperature
2 to 8°C