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Model NO.: 19387-91-8
Mf: C8h13n3o4s
MW: 247.27
Trademark: JCJ
Transport Package: 25kg
Specification: USP
Origin: China
HS Code: 1111111111
Antitrichomonal drug Tinidazole CAS: 19387-91-8 White Powder

Description:

Tinidazole is a drug used against protozoan infections. It is widely known throughout Europe and the developing world as a treatment for a variety of amoebic and parasitic infections. It was developed in 1972 and is a prominent member of the nitroimidazole antibiotic class.

Tinidazole is marketed by Mission Pharmacal under the brand name Tindamax, by Pfizer under the names Fasigyn and Simplotan, and in some Asian countries as Sporinex.

Basic information:

Chemical name: Tinidazole
MF: C8H13N3O4S
MW: 247.27
CAS: 19387-91-8
Appearance: white powder
Purity: over 99%
Usage: antitrichomonal drug

COA:
 
Product name Tinidazole
CAS No. 19387-91-8 Outer Packing 50KG
Production date 2017.02.20 Shelf life 2019.02.19
Standard adopted SFDA(IDL)
Items of analysis Specification Results
Characters
White or pale yellow crystalline powder 		Conforms
Solubility Practically insoluble in water , soluble in acetone and in methylene chloride, springly soluble in methanol. Conforms
Identification 1,2,3 Conforms
Appearance of solution The sample soiution is clear.Any opalescence produced with test solution is moatnore produced is not more pronounced than reference suspension 1and any colour produced is not more intense than reference solutiom Y5 Conforms
Impurity A NMT 0.2% N.D
Impurity B NMT 0.2% 0.053%
Any other unidentified impurity NMT0.1% 0.054%
Total impurities NMT 0.4% 0.170%
Monochlorobenzene ≤ 360ppm 10ppm
Loss on drying NMT 0.5% 0.24%
Sulphated ash NMT 0.1% 0.04%
Heavy metals NMT 10ppm Conforms
Assay NLT 99.0% 100.13%
Conclusion Qualified

Background:

Tinidazole (tye nid' a zole) is an oral, broad spectrum antimicrobial that has activity against bacteria as well as several parasites such as Entamoeba histolytica, Giardia duodenalis and Trichomonas vaginalis.  Tinidazole is a nitroimidazole similar to metronidazole and is activated intracellularly by bacterial or parasitic enzymes to a radical anion, which damages large protein molecules and DNA.  Tinidazole was approved for use in the United States in 2004 and current indications are for treatment of trichomoniasis, giardiasis, amebiasis and bacterial vaginosis.  Tinidazole is available in tablets of 250 and 500 mg and the dose varies by indication, being 2 grams as a single oral dose in adults with trichomoniasis and giardiasis, and for 3 to 5 days for moderate or severe forms of amebiasis.  Oral tinidazole is generally well tolerated if being used generally for only 1 to 5 days.  Side effects can include metallic or bitter taste, fatigue, dizziness, headache, dyspepsia, nausea, and a disulfiram-like response to alcohol.  Rare, but potential serious adverse events include allergic reactions, anaphylaxis and toxic megacolon.

How to use Tinidazole:

Take this medication by mouth as directed by your doctor, usually once daily. To prevent stomach upset, take this medication with food. The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.

For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tinidazole in children below 3 years of age. Safety and efficacy have not been established. It is only used in children three years of age and older for the treatment of giardiasis and amebiasis .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of tinidazole in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require adjustment of dosage in patients receiving tinidazole.

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