Product Overview
Capecitabine is a very efficient oral chemotherapy drug that is a type of fluoropyrimidine carbamate.
It acts as a prodrug. The main place where it changes into its active form, 5-fluorouracil (5-FU), is in tumor tissues.
This tailored activation makes the treatment less harmful and more effective.
Capecitabine API is a good fit for outpatient cancer care.
It has a lot of clinical benefits and is easy for people to use.
The chemical is employed a lot in both basic and advanced cancer treatment.
We manufacture Capecitabine in our industry. We have strong measures in place to check the quality.
We also follow the Good Manufacturing Practices (cGMP) that are used around the world.
Every step, from collecting the raw ingredients to putting them in the final package, is carefully planned.
This makes sure that the product is always the same, works, and is safe.
Therapeutic Applications
Therapeutic Cancer: Anti-cancer
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Colorectal Cancer: First-line treatment for metastatic colorectal cancer can be administered as monotherapy or in combination with other drugs.
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Breast Cancer: It is given to metastatic breast cancer patients who have not responded to anthracyclines and taxanes.
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Gastric cancer: It is used in advanced or metastatic instances, often as part of combination therapy
Specification Parameters
We take care and time to produce our Capecitabine. It fulfils the rules set by both the pharmacopoeia and us. This ensures that it is secure and operates well. Important parameters are:
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Name of the chemical: Capecitabine
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CAS Number: 154361-50-9
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Molecular formula: C15H22FN3O6
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Weight of the molecule: 359.35 g/mol
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Physical Form: A white to off-white crystalline powder
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Identification: IR and HPLC are both correct.
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HPLC assay: not less than 99.0%
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Solubility: It dissolves a little in water and easily in methanol and DMSO.
Packaging & Storage
Primary Packaging is done with sanitary LDPE/HDPE liners with double layers.
For secondary Packaging, use fiber drums or HDPE drums. They should have seals that can’t be broken. Put labels on them that follow international norms for safety and transit.
The labeling includes the name of the product, the batch number, the date it was made, and when it will expire, instructions for storage, and information about the rules.
Put it in a cool, dry, and airy place between 15°C and 25°C. Keep out of the sun and wetness.
Keep the pack tightly closed and away from anything that doesn’t work with it.
Why Choose Us
It is very important to choose a reliable API manufacturer for your pharmaceutical formulations. The following are the prominent reasons why our Capecitabine offering is different:
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Regulatory compliance: Manufactured in facilities that are WHO-GMP and ISO-certified, which means they are up to date. This makes sure that all batches are the same and that all rules are followed.
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Regulatory Documentation: Give full support for the DMF (Drug Master File). Include things like COA, MSDS, stability data, and a TSE/BSE declaration in the technical packages. This makes sure that registration goes smoothly and that you can access the global market.
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Quality Promise: We check each gram of Capecitabine to make sure it is safe, works, and is pure.
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Flexible and scalable production: works for both small formulators and large pharmaceutical firms. We can make batches of any quantity and get them to you quickly.
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Sustainability: We focus on eco-friendly production, cutting down on waste, and recovering solvents as part of our work. This makes our production more in line with green chemistry.
