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Ondansetron Hydrochloride

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MOQ : 100 Kilograms

Ondansetron Hydrochloride Specification

Loss on Drying
0.5%

Taste
Tasteless

Structural Formula
C18H19N3OHCl

EINECS No
627-129-7

Smell
Odorless

Melting Point
Approximately 178-180C

Heavy Metal (%)
0.001%

Molecular Weight
329.82 g/mol (base), 365.83 g/mol (hydrochloride salt)

Shelf Life
36 months

Ph Level
4.0 - 5.0 (1% aqueous solution)

Poisonous
No (When used as directed under medical supervision)

Color
White to off-white

Solubility
Freely soluble in water and methanol, sparingly soluble in ethanol

Storage
Store in a cool, dry place, protected from light and moisture.

HS Code
29339900

Boiling point
Not applicable (decomposes)

Particle Size
D90 < 100 microns

Molecular Formula
C18H19N3OHCl

Medicine Name
Ondansetron Hydrochloride

Chemical Name
Ondansetron Hydrochloride

CAS No
99614-02-5

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as an antiemetic to prevent nausea and vomiting associated with cancer chemotherapy, radiotherapy, and surgery.

Purity(%)
>99%

Appearance
White to off-white crystalline powder

Physical Form
Solid

Chloride Content
16.0% - 17.0%

Packaging
HDPE drum with double polyethylene bags

Assay (by HPLC)
99.0%

Identification (IR, UV)
Complies

pKa
7.4 (approximate)

Residual Solvents
Complies with ICH guidelines

Microbial Limit
Complies with pharmacopeial standards

Related Substances
0.2%

Ondansetron Hydrochloride Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
1000 Kilograms Per Month

Delivery Time
7 Days

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

About Ondansetron Hydrochloride

Generic Name : Ondansetron Hydrochloride
CAS Number : 67914-60-7
Grade : IP/BP/USP
Packing Type : Drum
Therapeutic use : Antagonist, Antiemetics, Antinauseants
Product MOQ : 25 kgs

Unmatched Purity and Compliance

Ondansetron Hydrochloride stands out with an assay of 99.0% and purity greater than 99%, ensuring exceptional quality for pharmaceutical applications. Every batch complies with ICH guidelines for residual solvents, as well as stringent pharmacopeial standards for microbial and heavy metal content, making it highly reliable for medical use.

Versatile Antiemetic Use

This API is widely used in the formulation of antiemetic medications. Ondansetron Hydrochloride helps prevent and control nausea and vomiting induced by cancer chemotherapy, radiotherapy, and surgery, improving patient quality of life and treatment outcomes. Its tasteless and odorless profile ensures suitability for a range of oral and injectable formulations.

Safety, Packaging, and Storage

Ondansetron Hydrochloride is securely packaged in HDPE drums with double polyethylene bags, preserving its integrity during storage and transport. It should be stored in a cool, dry place, shielded from light and moisture, and offers a shelf life of 36 months. Compliance with storage recommendations ensures sustained potency and safety.

FAQ's of Ondansetron Hydrochloride:

Q: How is Ondansetron Hydrochloride typically used in medical settings?

A: Ondansetron Hydrochloride is used as an active ingredient in antiemetic medications to prevent nausea and vomiting caused by cancer chemotherapy, radiotherapy, and surgical procedures. It is formulated into oral or injectable dosage forms, prescribed and administered under medical supervision.

Q: What measures ensure the quality and safety of Ondansetron Hydrochloride?

A: This API undergoes stringent testing for purity, with an HPLC assay of 99.0%, and compliance with ICH guidelines for residual solvents and pharmacopeial standards for microbial and heavy metal content. Its identification is confirmed by IR and UV, and each batch is securely packaged to maintain product integrity.

Q: When should Ondansetron Hydrochloride be stored to maintain optimal quality?

A: It should always be stored in a cool, dry environment, protected from moisture and direct sunlight. Proper storage conditions help preserve its physical and chemical stability, ensuring a 36-month shelf life from the date of manufacture.

Q: Where is Ondansetron Hydrochloride typically manufactured and supplied from?

A: Ondansetron Hydrochloride is manufactured, exported, and supplied widely from India. The country is a leading hub for pharmaceutical-grade APIs, ensuring adherence to international quality and regulatory requirements.

Q: What is the solubility profile of Ondansetron Hydrochloride?

A: Ondansetron Hydrochloride is freely soluble in water and methanol, but sparingly soluble in ethanol, allowing flexibility in formulation for both oral and injectable preparations.

Q: What are the main benefits of using Ondansetron Hydrochloride as an antiemetic?

A: Its high purity, excellent compliance with safety standards, and proven efficacy in controlling nausea and vomiting make Ondansetron Hydrochloride a preferred choice for pharmaceutical manufacturers. Patients benefit from improved treatment tolerance during chemotherapy, radiotherapy, or surgery.

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