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Oxymetazoline HCl

Oxymetazoline HCl

nan INR/Kilograms

Product Details:

X

Oxymetazoline HCl Price And Quantity

  • nan INR/Kilograms
  • 500 Kilograms

Oxymetazoline HCl Trade Information

  • Cash Advance (CA) Telegraphic Transfer (T/T) Letter of Credit (L/C) Cash in Advance (CID)
  • Days
  • South America Western Europe Australia North America Eastern Europe Central America Africa Middle East Asia
  • All India
  • GMP Drug Manufacturing Lic with schedule M ISO 9001:2008 ISO 22000:2018 Vegetarian Certificate Halal Certificate

Product Description

With an aim to cater the diverse range of needs of clients, we are presenting our clients pure Oxymetazoline HCl. The offered chemical is globally used for treating nasal congestion and pregnancy problems and is highly demanded in pharmaceutical industry. It is processed under the stern guidance of our experts utilizing optimum grade chemical substances. Further, Oxymetazoline HCl is made available for our prestigious clients at industry leading prices.

Features:

  • Purity

  • Accurate composition

  • Precise pH value

  • Long shelf life

Specifications:

  • Molecular Weight : 296.84
  • Molecular Formula : C16H24N2O.HCl

Grades

USP

BP/EP

Description

A white to practically white, fine crystalline powder. Is hygroscopic.

A white or almost white crystalline powder.

Solubility

Soluble in water, in alcohol, practically insoluble in benzene, in chloroform and in ether.

Freely soluble in water and in ethanol (96%).

Melting Point

Should melts at about 300oC with decomposition.

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Identification

a) By IR

IR spectrum of sample recorded as Nujol mull should exhibit transmission minima (absorption maxima) at the same wavelengths to those in the spectrum obtained with the Oxymetazoline hydrochloride-working standard.

a) By IR

IR spectrum of sample recorded as KBr should exhibit transmission minima (absorption maxima) at the same wavelengths to those in the spectrum obtained with the Oxymetazoline hydrochloride working standard.

b) By UV (100 -µg/ml in water)

Absorptivities at 279 nm, calculated on the dried basis, should not differ by more than 3.0 %.

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c) By Chloride test

A curdy white precipitate should form, which settles in the test tube, indicating the presence of chlorides ions.

c) By Chloride test

A curdy white precipitate should form, which settles in the test tube, indicating the presence of chlorides ions.

pH (5 % w/v solution in water)

Between 4.0 and 6.5

-

Appearance of solution (5 % w/v solution in water)

-

Solution S should be clear and not more intensely coloured than reference solution BY7

Acidity/Alkalinity

-

Not more than 0.4 ml of 0.01 M of sodium hydroxide require to change the colour of the indicator to yellow.

Related Substances (% w/w, by HPLC)
Ph.Eur. Impurity A
Ph.Eur. Impurity B
Ph.Eur. Impurity C
Ph.Eur. Impurity D
Ph.Eur. Impurity E
Any unspecified
Total

-


Not more than 0.1
Not more than 0.10
Not more than 0.10
Not more than 0.10
Not more than 0.10
Not more than 0.10
Not more than 0.5

Loss on drying (% w/w, determined on 1 g at 105oC, for 3 hrs)

Not more than 1.0

Not more than 1.0

Sulphated ash

(% w/w, determined on 1.0g)

-

Not more than 0.1

Residue on Ignition (%w/w, determined on 1 g)

Not more than 0.1

-

Heavy metals (%w/w)

Not more than 0.001

-

Assay (% w/ w, By Titrimetry, as C16H24N2O.HCl on dried basis)

-

Not less than 99.0 and Not more than 101.0

Assay (% w/w, by HPLC as C16H24N2O.HCl on dried basis)

Not less than 98.5 and Not more than 101.5

-

Residual solvent (by GC, g/g)
Methanol
Acetone
Isopropyl alcohol
Ethyl acetate
Dimethyl sulfoxide
Toluene

Additional solvent

Benzene

-

Not more than 1000
Not more than 1000
Not more than 1000
Not more than 1000
Not more than 1000
Not more than 500
Not more than 2

For BP/EP

  • Impurity A = N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl] acetamide
  • Impurity B = Xylometazoline or (2-[4-(1,1-dimethylethyl)-2,6-dimethylbenzyl]-4,5-dihydro-1H-imidazole)
  • Impurity C=2- [4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl] acetamide
  • Impurity D = [4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl] acetic acid
  • Impurity E = [4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl] acetonitrile.
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