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99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms

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99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms

China 99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms supplier
99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms supplier 99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms supplier

Large Image :  99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms

Product Details:

Place of Origin: Wuhan,Hubei
Brand Name: Yuancheng
Certification: ISO9001
Model Number: 153439-40-8

Payment & Shipping Terms:

Minimum Order Quantity: 10g
Price: Negotiatable
Packaging Details: Discreet packaging
Delivery Time: 4-7 working days
Payment Terms: T/T, Western Union, MoneyGram,bitcoin
Supply Ability: 5000kg/month
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Detailed Product Description
Name: 153439-40-8 CAS: 153439-40-8
Molecular Formula: C32H40ClNO4 Formula Weight: 538.12
Purity: 99.13% Appearance: White Crystalline Powder

99.13% Raw Pharmaceutical White Powder Fexofenadine HCL To Treat Allergy Symptoms
Molecular Formula:C32H40ClNO4
Formula Weight: 538.12
CAS No.:153439-40-8
Purity:99.13%
Appearance;white crystalline powder

Fexofenadineis an antihistamine pharmaceutical drug used in the treatment of allergy symptoms, such as hay fever, nasal congestion, and urticaria.Therapeutically, fexofenadine is a selective peripheral H1-blocker.

 

Fexofenadine is classified as a second-generation antihistamine because it is less able to pass the blood-brain barrier and cause sedation, compared to first-generation antihistamines.It has also been called a third-generation antihistamine, although there is some controversy associated with the use of the term.

 

Medical uses:
Fexofenadine is used for relief from physical symptoms associated with seasonal allergic rhinitis and for treatment of chronic urticaria. It does not cure but rather prevents the aggravation of allergic rhinitis and chronic idiopathic urticaria and reduces the severity of the symptoms associated with those conditions, providing relief from repeated sneezing, runny nose, itchy eyes or skin, and general body fatigue.

 

Dosage:
Fexofenadine has been demonstrated to be safe and effective for children ages 2–5 years old and 6–11 years old in treatment of seasonal allergic rhinitis. Recommended doses of fexofenadine in UK labeling referenced below are: For adults with seasonal allergic rhinitis (hay fever): 60 mg twice daily or 120 mg taken once a day. For children aged 6–12 years with seasonal allergic rhinitis (hay fever): 30 mg taken twice a day, in the morning and evening. For adults with chronic urticaria: 180 mg taken once a day. For adults with chronic nasal congestion.

Renal Impairment: Due to decreased renal elimination in patients with creatinine clearance of less than 80mL/min, it is recommended that patients with renal impairment are started on a lower dose.[11]
Hepatic Impairment: Perhaps because only a small percentage of fexofenadine is metabolized in the liver, altered levels of drug are not seen in patients with hepatic impairment and therefore doses do not need to be adjusted in this population.

 

The COA:

 

 

Product name

 

fexofenadine hcl

 

 

CAS No.

153439-40-8

 

Outer Packing

 

25KG/DRUM

 

Production date

MARCH 2015

 

Shelf life

FEB.2020

 

Standard adopted

 

USP 38

 

Items of analysis

 

Specification

 

Results

description

 

 

a white or almost white crystalline powder

almost white crystalline powder

 

solubility

 

freely soluble in methanol and ethanol,very slightly soluble in acetone,and insoluble in hexance.

 

complies

 

identification

 

   

A. By I.R.

 

 

determine by infrared absorption spectrophotometry.compare the spectrum with that obtained with fexofenadine hydrochloride RS or with the referrence spectrum of fexofenadine hydrochloride.

 

complies

 

 

 

B. By HPLC

the retent ion time of the major peak as obtained in the assay test of the sample solution corresponds to that of the standard solution.

 

complies

 

C.Chlorides

 

 

a white precipitate should be formed

complies

 

water(by KF% W/W)

 

 

not more than 2%

 

0.22%

residue on ignition(% w/w)

 

 

not more than 0.1%

0.06%

 

content of chloride(on anhydrous basis % w/w)

 

NLT 6.45% and NMT 6.75%

 

6.55%

 

heavy metals(ppm)

 

not more than 20ppm

 

less than 20 ppm

 

related compounds(by HPLC)

 

 

 

 

 

related compound A

 

 

NMT 0.20%

0.01%

 

decarboxylated degradant

 

NMT 0.15%

 

 

Not detected

any other unkonwn impurity

 

NMT 0.10%

 

0.052%

 

 

total impurities

 

NMT 0.5%

 

0.15%

limit of fexofenadine related compound

 

not more than 0.20%

 

0.11%

 

assay(By HPLC,%w/w)(on anhydrous basis)

 

 

not less than 98.0% and not more than 102.0%

99.13%

 

residual solvents/organic impurities(by GC with HSS,ppm)

 

 

 

 

 

methanol

 

NMT 3000

 

278.59

 

ethanol

 

 

NMT 5000

not detected

 

 

isopropyl chloride

NMT 15

 

not detected

 

 

isopropyl alcohol

 

NMT 5000

 

311.36

 

methyl acetate

NMT 5000

 

 

not detected

 

 

tetra hydro furan

 

NMT 720

not detected

 

 

 

methylene dichloride

 

NMT 600

 

not detected

 

ethyl acetate

 

 

NMT 5000

 

60.22

isopropyl acetate

 

 

NMT 5000

 

not detected

toluene

 

NMT 890

 

 

6.25

 

methyl isobutyl ketone

NMT 5000

 

1979.5

 

acetone

 

 

NMT 5000

 

not detected

particle size

 

90% should pass through 100 microns

 

complies

 

 

Conclusion

 

Qualified

 

99.13% Raw Pharmaceutical Powder Fexofenadine HCL To Treat Allergy Symptoms

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