Product Overview
Ifosfamide is a pharmaceutical active substance (API) that is utilised in cancer therapy.
It is a class of chemicals known as alkylating agents.
Such chemicals are utilised due to their ability to prevent the growth of some rapidly dividing cells, particularly cancer cells.
Pure Ifosfamide is a white or off-white powder that is fine.
Ifosfamide is very soluble in water and other liquids used in the manufacture of medicines.
Its molecular formula is C7H15Cl2N2O2P, and its weight is 261.09 g/mol.
While it is similar to another drug called cyclophosphamide, Ifosfamide is has a distinct metabolic activation pathway compared to cyclophosphamide in the body.
It has to be processed by the liver to destroy cancer cells.
This unusual mechanism of action helps it treat some difficult-to-treat cancers.
Ifosfamide is not directly given to patients in its pure form.
Instead, it is exported to pharmaceutical manufacturing companies, where it is treated in strict conditions in order to be packaged into end doses of drugs.
The drugs are then given to patients in hospitals, usually through injections.
Because of its severe effects and risks, Ifosfamide must be treated with care, especially when moving, storing, and mixing it.
Therapeutic Applications
Ifosfamide is a bulk drug that is utilised in the manufacture of anti-cancer medicines.
It is a type of drug called alkylating agents. Alkylating agents can form bonds with DNA.
This makes cells unable to grow or divide.
API is used in the laboratory and industry to see how the compound acts.
It can form strong bonds with DNA molecules, which inhibits the division of rapidly growing cells.
Researchers test the raw material to ascertain its purity, potency, and how it behaves when exposed to different conditions.
Ifosfamide is never given alone in human beings.
It must be converted into a safe substance by qualified personnel in licensed laboratories.
Its raw state is only for production and research purposes by licensed companies.
Specification Parameters
In order to be used as an API, Ifosfamide must meet precise quality standards.
These are specified by international pharmacopoeias like USP and EP.
Each batch is tested to confirm that it is safe, pure, and effective.
Only APIs meeting these rigorous standards are utilised in the production of medicine.
This guarantees the final product is safe and performs as intended.
Some of the most prevalent standards for testing include:
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Appearance: Off-white to white crystalline powder
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Identification: Identified using analytical methods like IR (infrared spectroscopy) and HPLC (high-performance liquid chromatography)
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Assay: Should be between 98.0% to 102.0%
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Water Content: Controlled using Karl Fischer titration, normally less than 1.0%
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Related Substances: Should contain traces of unwanted substances or impurities
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Residual Solvents: Controlled according to ICH Q3C guidelines
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Heavy Metals: Below the limit, normally 10 ppm or lower
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Melting Point and Rotation: Shall be in conformity with values reported for pure Ifosfamide
Packaging & Storage
Because Ifosfamide is a strong and sensitive chemical, how it is packed and stored matters a lot.
Since Ifosfamide is also toxic, those handling it must follow safety rules, including using gloves, masks, and protective clothing.
In manufacturing units, special safety measures are taken to avoid any contact or contamination.
Here are the normal storage guidelines for the API:
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Temperature: Keep in a cool place, between 2°C and 8°C
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Humidity: Must be stored in dry conditions; moisture can spoil the compound
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Container: Packed in double-sealed polyethylene bags and placed inside sealed HDPE or fibre drums
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Light Protection: The material is light-sensitive, so containers must be opaque or kept away from direct light
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Shelf Life: When stored properly, it usually lasts for 2 to 3 years
Why Choose Us
Pharma manufacturers of cancer medication, procuring good quality Ifosfamide is highly vital.
Actizia Industry ensures that the API is safe to use in drug manufacturing.
It also helps the manufacturers to meet local and global requirements for drug registration and safety.
Good quality suppliers ensure that every batch:
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Has a Certificate of Analysis (COA) ensuring purity and a test report
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Has complete regulatory assistance for documents like Drug Master Files (DMFs)
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It is manufactured under GMP (Good Manufacturing Practice) GMP-compliant facilities.
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It is shipped with care, with appropriate temperature and safety controls
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It is traceable to the extent that all stages of manufacturing and handling are recorded
