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Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder

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Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder

China Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder supplier
Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder supplier Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder supplier Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder supplier

Large Image :  Nasal Spray API Pharmaceutical Intermediates CAS 1218-35-5 Xylometazoline HCl Powder

Product Details:

Place of Origin: China
Brand Name: Simeiquan
Certification: IIOS9001
Model Number: 234324

Payment & Shipping Terms:

Minimum Order Quantity: 1kg
Price: 10USD
Packaging Details: 25kg carton box
Delivery Time: 1-3 working days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 1000kg per month
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Detailed Product Description
CAS: 1218-35-5 Assay: 99%
Market: Global
High Light:

active pharmaceutical ingredient

,

pharmaceutical active ingredients

1. Quick Detail:


English name: xylometazoline HCl
English Synonyms: XYLOMETAZOLINE HYDROCHLORIDE; XYLOMETAZOLIN HYDROCHLORIDE
CAS: 1218-35-5
EINECS Number: 214-936-4
Formula: C16H25ClN2
MW: 280.8361

Boiling point: 394.2 ° C at 760 mmHg
Flash Point: 192.2 ° C
Vapor Pressure: 4.56E-06mmHg at 25 ° C
Appearance: white powder
Assay: 99%

2. Description:


Xylometazoline (Pronunciation: Zylow-met-TAH-zoleen), also known as xylomethazoline, is a drug which is used as a topical nasal decongestant.It is applied directly into the nose, either as a spray or as drops.
Xylometazoline is marketed under many brand names (see below) but the most common by far is Otrivine. The standard adult solution strength is 0.1% w/V xylometazoline, and the dose for children under 12 is usually 0.05%.

It should not be used for too long a period of time, or rebound effect may occur after discontinuation (see: Rhinitis medicamentosa). It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system.

3. Specification:

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%)

-

 

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
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

 

 



4. Applications:


Allergy (hypersensitivity) to xylometazoline or any of the other ingredients
People who have undergone neurosurgery
People who are taking or who have taken drugs for depression called monoamine oxidase inhibitors within the previous 2 weeks
People taking other similar decongestants
Heart problems
Problems with blood circulation
High blood pressure (hypertension)
Overactive thyroid (hyperthyroidism)
People taking beta-blockers, which are used for high blood pressure (hypertension)
Inflammation of the skin or nose
People who have had their pituitary gland removed by surgery
Children under 12 years of age
Cancer of the adrenal gland (phaeochromocytoma)
A type of eye disease with increased pressure inside the eye called closed-angle glaucoma


5. Our advantange

Packing

Professional packing with professional materials, and We'll give clients several Packing way to choose after you contact me through my email

Quality

Our company is a professional leading factory in China in pharmaceutical area, ach batch of steroid powders have to tested by our QC(quality control) department before they are allowed to sell.

Delivery

We can pack your powders within 48 hours after your payment, and corresponding picture of your powders' parcel will be sent to you.

Price

Best prices you're sure to be satisfied, the more you buy, the more competitive prices you get.

Payment

T/T in advance , WU or Money Gram

 

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