Product Overview
Pemetrexed Disodium Heptahydrate is a raw material.
It is a material to be used in the manufacture of certain cancer drugs.
It is also known as an API, or active pharmaceutical ingredient.
An API is the part of a drug that functions to make it active. It is not an active drug in itself.
This is one of a group of drugs referred to as antifolates. Antifolates are drugs that inhibit some enzymes in the body.
These enzymes make use of folic acid in order to help cells grow and multiply.
When the enzymes are blocked, the cell cannot make DNA and RNA.
Without DNA and RNA, a cell cannot make copies of itself.
This is most harmful to very rapidly multiplying cells, like cancer cells.
The compound looks like a white or off-white powdered compound.
The compound dissolves in water. “Heptahydrate” is the name given to the fact that the compound has seven molecules of water within its solid structure.
This water is incorporated into the solid structure. It is utilized to stabilize the powder and to make the powder easier to handle.
It requires several chemical steps to synthesize this API. All of these steps are carried out in clean and controlled conditions.
It is monitored several times to be sure that the correct chemical is being formed.
After it has been produced, it is purified to remove unwanted chemicals. This process is called purification.
Every batch is tested in a laboratory. Only materials passing all tests are sent to consumers.
Tests check identity, purity, and other characteristics of great importance.
The plant complies with Good Manufacturing Practice rules, or GMP.
GMP is a collection of international guidelines that keep medicine ingredients safe, clean, and uniform.
Therapeutic Applications
In its raw API form, Pemetrexed Disodium Heptahydrate is used in the production of medicines for the treatment of non-small cell lung cancer and malignant pleural mesothelioma.
This is achieved through the capability of the drug to kill cancer cells’ growth.
The API is handled and used only by trained employees in approved facilities.
Specification Parameters
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CAS Number: 357166-29-1
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Molecular Formula: C20H23N5Na2O9·7H2O
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Molecular Weight: 597.49 g/mol (base anhydrous), greater with heptahydrate form
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Appearance: White or almost white crystalline powder
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Solubility: Highly soluble in water; very slightly soluble in most organic solvents
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Purity (HPLC): Not less than 98% (on anhydrous basis)
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Water Content: As for the heptahydrate form, controlled within a narrow range for stability
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pH (in aqueous solution): Usually between 7.0 and 8.5
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Related Substances: Each impurity ≤ 0.15%; total impurities ≤ 1.0%
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Residual Solvents: Below ICH Q3C levels, as identified by gas chromatography.
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Heavy Metals: Below pharmacopeial limits (tested by ICP-MS or equivalent).
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Microbiological Limits: Meets pharmacopeia specifications; tested and found to be free of pathogenic microbial contamination.
Packaging & Storage
This API is packed to protect it from damage. A most general pack is a double plastic bag in a rugged fiber drum.
One drum can hold 25 kg of powder. Other packs can be produced for experimentation or small-scale manufacture.
Storage instructions
A tamper-evident seal is used. That is, you can tell whether the pack has been opened.
This is for assurance that the product is safe to be sent in transit.
The API is to be stored accurately between 2 and 8 degrees Celsius.
It should be stored away from moisture, in a clean area with proper air movement.
It should not be left in a position of direct sunlight. The container should be kept closed until the powder is needed.
Moisture, heat, or light can change the product and lower its quality.
Stored properly, Pemetrexed Disodium Heptahydrate will be good for up to 36 months from when we made it.
Why Choose Us
Actiza Industry produces and supplies high-quality APIs for oncology drugs.
Pemetrexed Disodium Heptahydrate is one of our best-selling products.
We supply it to buyers in many countries.
Our pharmaceutical facilities operate as per WHO-GMP and ISO guidelines.
This means every batch is produced and analyzed to meet stricter international standards.
We check the product many times while it is being manufactured.
We only provide those batches passing all the tests to the customers.
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We give our customers full technical data. This includes Drug Master Files, method validation reports, and stability. Our regulatory specialists help customers with product approval in the customer’s country.
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We can make small quantities for testing or large quantities for complete production. It is easy for customers to get just the right amount when they need it.
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We plan ahead for production and keep inventory in surplus. This avoids delays or shortages. We work with seasoned shipping partners who can manage temperature-sensitive materials.
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Actiza Industry is always working to improve our APIs. We’re working towards higher yield, less waste, and cleaner processes. We’re environmentally responsible and quality-focused.
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We have very skilled technical individuals who can answer questions about our API. That includes how to deal with it, store it, and incorporate it in production.
