Fentanyl Citrate E.P./ USP

Main Info

Chemical name

N- phenyl-N-[1-(2-phenylethyl) piperidin-4-yl] propanamide dihydrogen2-hydroxypropane-1,2,3-tricarboxylate

CAS No.

990-73-8

Physical form

A white crystalline powder or white glistening crystals

Therapeutic category

Opiate analgesic (narcotic)

Structural formula

northernsynthesis-formulas-05

Molecular formula

C₂₂H₂₈N₂O. C₆H₈O₇

Molecular mass

528.6

Specification

Characters

Soluble in water, freely soluble in methanol, sparingly soluble in ethanol (96%), slightly soluble in chloroform.

Identification

Tests as per E.P/USP

Related substance (HPLC)

As per E.P.

Ordinary impurities(TLC)

As per USP

Loss on drying, %

NMT 0.5

Assay (dried substance), %

Between 99.0 to 101.0

Appearance of solution

As per E.P.

Melting point, °C

About 152 °C (with decomposition)

Residue on ignition

As per USP

Heavy metals

As per USP

Clarity and color of solution (Ph. Eur. cur. ed. 2.2.1.; 2.2.2)

Clear and colorless solution (in 0,03% citric acid)

Chemical name

CAS No.

Physical form

Therapeutic category

Structural formula

Molecular formula

Molecular mass

Characters

Identification

Related substance (HPLC)

Ordinary impurities(TLC)

Loss on drying, %

Assay (dried substance), %

Appearance of solution

Melting point, °C

Residue on ignition

Heavy metals

Clarity and color of solution (Ph. Eur. cur. ed. 2.2.1.; 2.2.2)

Products

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Fentanyl Citrate E.P./ USP

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Terpin Hydrate USP

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