Product Overview
Ondansetron Base is an active pharmaceutical ingredient (API) utilized to produce medications.
It is a 5-HT3 receptor antagonist, i.e., it inhibits the action of serotonin, a naturally occurring compound in the body.
Ondansetron Base is not a medication that is directly administered to patients.
Instead, it is used by pharmaceutical manufacturers to create finished products such as injections, syrups, or tablets.
Therapeutic Applications
Ondansetron Base is a selective antagonist.
It inhibits receptors for serotonin triggered in certain medical procedures.
The API is selected on the grounds of stability, performance, and formulation compatibility.
Its occurrence in product pipelines is typically in antiemetic forms, where regulation of serotonin is needed.
Research and development teams make use of Ondansetron Base when coming up with products for conditions of emesis.
Specification Parameters
The API is tested for purity, strength, and other key parameters before being released to the customer.
These specifications allow manufacturers to develop safe and efficacious finished products.
Ondansetron Base (CAS number 99614‑02‑5) has a molecular formula of C18H19N3O and a molecular weight of 293.37 g/mol.
It is in the form of a white to off-white powder.
The appearance is examined for uniformity in every lot.
Identity tests by IR, UV, and HPLC techniques confirm the product identity.
The purity of the API is typically greater than 98%, as determined by HPLC.
Related substances, including impurities, are maintained at a level of less than 1.0% total.
Any impurity must not be more than 0.5%.
The water content, determined by the Karl Fischer technique, is less than 1.0%.
Residue on ignition does not exceed 0.1%.
Heavy metals, as they are toxic, are restricted to less than 10 parts per million.
The API is easily soluble in methanol and ethanol, but marginally soluble in water.
These solubilities help formulators decide how to deal with the product.
Stability studies reveal that the API is within limits for a period of 3 years when stored under the proper conditions.
Tests are all as per pharmacopoeial recommendations, such as USP, EP, IP, or BP, whichever is required by clients.
Packaging & Storage
Ondansetron Base is packed in clean and safe containers.
The containers protect the product against heat, light, and moisture.
HDPE or LDPE containers with two inner polybags are the typical packaging.
The outer container is sealed tightly and labeled with all the information.
This includes batch number, manufacturing and expiry dates, net weight, and storage instructions.
Pack sizes are 1 kg, 5 kg, or 10 kg as standard. Pack sizes can be adjusted according to the client’s requirements.
The API has to be stored at a temperature between 2°C and 8°C.
It must be maintained in a dry, airy environment.
It should be kept away from sunlight and in tightly closed containers.
The warehouses have to follow the GMP principles to ensure the safety of the product until it is used in production.
Proper storage helps to guarantee that the API is stable and efficacious throughout its shelf life.
Why Choose Actiza Industry
Actiza Industry is a name you can trust in the manufacturing and export of the API business.
We have strict quality standards and serve customers in many countries.
We offer Ondansetron Base as a quality API for formulation. Some companies use our API for the manufacture of their branded or generic drugs.
We follow cGMP guidelines in our manufacturing units. Our facilities are all health authority-inspected and approved.
Our API is manufactured in controlled environments, utilizing advanced processes and skilled manpower.
This renders our product pure, consistent, and safe.
State-of-the-art equipment is utilized to test the product for identity, strength, and impurities.
Complete documentation, like Certificate of Analysis (CoA), MSDS, and open portion of DMF, is also offered by us.
Our regulatory team supports clients with the necessary documentation for product registration in their respective countries.
Actiza Industry has a well-organized supply chain. We have trusted logistics partners who deliver on time worldwide.
We also offer customers flexible batch sizes, packaging options, and delivery schedules.
Our warehouse personnel take proper care that the product is in good condition when it reaches the customer.
We also have a strong R&D and quality assurance team.
The team is involved in process development, impurity profiling, and technical support.
We support our customers by offering technical data, formulation support, and document support as and when needed.
