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Xylometazoline Hydrochloride

Xylometazoline Hydrochloride

Product Details:

  • Structural Formula C16H24N2.HCl
  • Molecular Weight 280.84 Grams (g)
  • Solubility Freely soluble in Water, in alcohol and in methanol
  • Loss on Drying Not more than 0.5%
  • Molecular Formula C16H24N2.HCL
  • Ph Level 5.0-6.6
  • Storage Room Temperature
  • Supply Ability : 200 Kilograms Per Day
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Price And Quantity

  • 500 Kilograms

Product Specifications

  • Freely soluble in Water, in alcohol and in methanol
  • Not more than 0.5%
  • Powder
  • C16H24N2.HCl
  • 280.84 Grams (g)
  • C16H24N2.HCL
  • 5.0-6.6
  • Room Temperature
  • Vasoconstrictor, used as a nasal decongestant.
  • 1218-35-5

Trade Information

  • Telegraphic Transfer (T/T), Letter of Credit (L/C), Cash in Advance (CID), Cash Advance (CA)
  • 200 Kilograms Per Day
  • 1 Days
  • All India
  • GMP Drug Manufacturing Lic with schedule M ISO 9001:2008 ISO 22000:2018 Vegetarian Certificate Halal Certificate

Product Description

Our firm is betrothed in offering supreme quality Xylometazoline HCl to our esteemed clients. It helps to decrease nasal congestion and is demanded in pharmaceutical industry to make medicines for treatment of high blood pressure. This chemical is formulated at our well equipped formulating unit under the stern guidance our dexterous professionals. The offered Xylometazoline HCl is available in a variety of packaging options to meet the diverse needs of our clients. This extract is strictly tested by our team of quality analysts prior to dispatch from our end.

Features:

  • High effectiveness

  • Longer shelf life

  • Purity

  • Accurate composition

  Specifications:

  • Molecular Weight : 280.84
  • Molecular Formula : C16H24N2.HCl

Grades

IP

BP/EP

USP

Description

A White or almost white, crystalline powder; odorless or almost odorless.

White to off-white, odorless crystalline powder

White to off-white, odorless crystalline powder

Solubility

Freely soluble in Water, in alcohol and in methanol. Practically insoluble in ether

Soluble in water, freely soluble in alcohol, Sparingly soluble in chloroform, practically insoluble in benzene and in ether

Soluble in water, freely soluble in alcohol, Sparingly soluble in chloroform, practically insoluble in benzene and in ether

Identification

a) By IR (KBr)
IR spectrum of sample recorded as KBr should exhibit maxima and minima at the same wavelengths as that of the similar preparation of IR spectra of Xylometazoline Hydrochloride working standard.
a) By IR
IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS.
a) By IR
IR Spectrum of test sample is concordant with IR Spectrum of Xylometazoline Hydrochloride WS.
b) by UV
An absorbance should be maximum at about 265 nm and minimum at about 257 nm with two inflections at about 270 nm and 275 nm.
Absorbance at about 265 nm, about 0.5
b) by TLC
The principle spot obtained in test solution is similar in position and size to the principle spot in the chromatogram obtained with Xylometazoline Hydrochloride WS.
b) By TLC
The size ,intensity and Rf value of principal spot obtained from The test solution correspond to those of the principal spot obtained from the Xylometazoline Hydrochloride WS-solution.
c) By chemical test
A violet color should produce.
c) Melting Point
Melts at 300oC with decomposition
c) Melting Point
Melts above 300oC with decomposition
d) Test for Chloride
A curdy white precipitate should form, which settles in the test tube, indicating presence of chloride ions.

-

-

pH (5.0 % w/v solution in water)

Between 5.0 to 6.6

-

Between 5.0 & 6.6

Appearance of solution (5.0% in water)


5.0 % solution in water is clear


Acidity/Alkalinity


Not more than 0.2 ml 0.01 M NaOH is required.


N-(2-Aminoethyl)-4-tert butyl-2,6-xylylacetamide by TLC

Any spot corresponding to N-(2-Aminoethyl)-4-tert butyl-2,6-xylylacetamide in the chromatogram obtained with the test solution should not more intense than the spot in the chromatogram obtained with the reference solution (0.5%)

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Related substances
(%, by HPLC)
Xylometazoline impurity A
Any other impurity
Total impurities
(%, by HPLC)

Not more than 0.2
Not more than 0.1
Not more than 0.5

(by TLC)

Not more than 0.2 %

Not more than 0.2 %


Iron (ppm)

Not more than 50

-


Sulphates (ppm)

Not more than 200

-


Sulphated ash (%w/w, determined on 1g)

Not more than 0.1

Not more than 0.1 %


Residue on Ignition

-

-

Not more than 0.1 %

Chromatographic Purity

-

-

Complies with standard

Loss on drying (%w/w, determined on 1g at 105oC, for 4 hr.)

Not more than 0.5


Not more than 0.5 %


Not more than 0.5 %

Assay (%w/w C16H24N2HCl , on dried basis)

(by Titrimetry)
Not less than 99.0 and Not more than 101.0
(by Potentiometer)
Between 99.0 % and 101.0 %
(by Potentiometer)
Between 99.0 % and 101.0 %
Residual Solvents
(by GC, g/g)
Methanol
Acetone
Isopropyl alcohol
Tert butyl alcohol
Ethyl acetate
Benzene
Methyl iso butyl ketone
Toluene
m-Xylene



Not more than 3000
Not more than 3000
Not more than 3000
Not more than 3000
Not more than 3000
Not more than 2
Not more than 500
Not more than 890
Not more than 500




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