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Clopidogrel Bisulfate Form 1

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MOQ : 50 Kilograms

Clopidogrel Bisulfate Form 1 Specification

Smell
Odorless

Purity
99% minimum

Shape
Crystalline

Molecular Weight
419.9 g/mol

Physical Form
Solid

Solubility
Slightly soluble in water, freely soluble in methanol and ethanol

Molecular Formula
C16H16ClNO2S H2SO4

Usage
Formulation of oral solid dose (tablet)

CAS No
120202-66-6

Properties
Antiplatelet agent; Used to inhibit blood clots

Shelf Life
36 months from date of manufacture when stored appropriately

Structural Formula
Available upon request

Application
Used as an antiplatelet medication to prevent strokes and heart attacks

Ingredients
Clopidogrel Bisulfate

HS Code
29334900

Ph Level
Not determined

Storage
Store in a cool, dry place away from direct sunlight

Poisonous
No (if used as directed)

Taste
Odorless; not specified

Grade
Pharmaceutical Grade

Appearance
White to off-white crystalline powder

Product Type
Active Pharmaceutical Ingredient (API)

Density
Gram per cubic centimeter(g/cm3)

Refractive Rate
Not determined

Melting Point
Between 182 to 184C

Synonyms
Plavix, Clopilet, Cardlet

Storage Conditions
Temperature below 30C, protected from moisture

Packaging
Packaged in double PE bags placed in HDPE drums

Particle Size
D90 < 40 microns

Grade Standard
USP, EP compliant

IUPAC Name
Methyl (S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate bisulfate

Therapeutic Class
Antithrombotic agent

Hazard Statements
Non-hazardous under normal handling

Clopidogrel Bisulfate Form 1 Trade Information

Minimum Order Quantity
50 Kilograms

Supply Ability
1 Kilograms Per Week

Delivery Time
1 Week

About Clopidogrel Bisulfate Form 1

Clopidogrel Bisulfate Form 1

Specifications :

Appearance	White to off white powder.
Identification	Infrared absorption spectrum accord with reference substance spectrum.
Identification	The retention time in the major peak in the chromaogram of the assay preparation corresponds to that in the chromatogram of the standard preparation.
Loss of drying	d 0.5%
Residue on Ignition	d 0.1%
Related Substances	Impurity A d 0.2%
	Impurity B d 0.3%
	Impurity C d 1.00%
	Other Impurity d 0.1%
	Total Impurity d 1.5%
Assay (on dried basis)	97% ~ 101.5%

Clinical Application and Therapeutic Benefits

Clopidogrel Bisulfate Form 1 is widely utilized to reduce the risk of thrombotic cardiovascular events, such as strokes and heart attacks, especially in patients with a history of arterial blockages. It works as an antiplatelet agent, reducing the likelihood of harmful clot formation. Its effectiveness, high purity, and favorable safety profile make it an essential component in oral medications for cardiovascular health.

Stringent Pharmaceutical Standards and Packaging

Manufactured to meet USP and EP pharmaceutical standards, Clopidogrel Bisulfate Form 1 is carefully packaged in double PE bags and HDPE drums. This ensures product integrity and safeguards against environmental factors. Regular quality checks confirm that it consistently achieves a D90 particle size of less than 40 microns and a minimum purity of 99%, upholding its reliability for formulators and healthcare distributors.

Storage, Handling, and Safety Requirements

The product is classified as non-hazardous when handled under normal conditions. To preserve its stability and efficacy, it should be stored at temperatures below 30C, protected from moisture, in a cool, dry place away from direct sunlight. When stored properly, Clopidogrel Bisulfate maintains a shelf life of up to 36 months, ensuring long-term usability for manufacturers and pharmacies.

FAQs of Clopidogrel Bisulfate Form 1:

Q: How is Clopidogrel Bisulfate Form 1 used in pharmaceutical formulations?

A: Clopidogrel Bisulfate Form 1 is commonly used in the formulation of oral solid dose medications, particularly tablets, where it acts as an active pharmaceutical ingredient to prevent blood clot formation in patients at risk of cardiovascular events.

Q: What are the benefits of using Clopidogrel Bisulfate Form 1?

A: The main benefits include its proven efficacy as an antiplatelet agent, high purity (minimum 99%), and compliance with USP and EP standards. Its use significantly reduces the occurrence of strokes and heart attacks in susceptible individuals.

Q: When should Clopidogrel Bisulfate Form 1 be stored, and for how long can it be kept?

A: The product should be stored immediately upon receipt in a cool, dry environment, away from sunlight and moisture, at temperatures below 30C. Under optimal conditions, it maintains its quality for up to 36 months from the manufacturing date.

Q: Where does Clopidogrel Bisulfate Form 1 find its primary application?

A: It is primarily utilized in the pharmaceutical industry for the manufacture of antiplatelet oral medications targeted at preventing clot-related cardiovascular incidents such as strokes and heart attacks.

Q: What is the process for packaging and distributing Clopidogrel Bisulfate Form 1?

A: Clopidogrel Bisulfate Form 1 is packaged in double polyethylene (PE) bags, which are then securely placed in high-density polyethylene (HDPE) drums to maintain product integrity during transportation and storage. It is distributed by manufacturers and suppliers throughout India and globally.

Q: What are the appropriate storage requirements for Clopidogrel Bisulfate Form 1 to ensure stability?

A: It must be stored below 30C, protected from moisture and direct sunlight, in a cool and dry location. Following these storage guidelines ensures that the compound remains stable and retains its efficacy throughout its 36-month shelf life.

Q: Is Clopidogrel Bisulfate Form 1 hazardous to handle or use?

A: No, Clopidogrel Bisulfate Form 1 is considered non-hazardous under normal handling and usage when used as directed in pharmaceutical formulations. Standard safety precautions should still be observed to maintain product quality.

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