Product Overview
Gemcitabine Hydrochloride is a synthetic pyrimidine nucleoside analog that is chemically similar to deoxycytidine.
It is a well-known antineoplastic drug that is used to treat several solid cancers.
Gemcitabine Hydrochloride, when formulated into finished medicines is phosphorylated inside cells to create active forms, such as Gemcitabine diphosphate and triphosphate.
These forms limit DNA synthesis in two ways: they block ribonucleotide reductase and get into the DNA chains.
This mechanism stops cells from growing and causes them to die.
The API is manufactured in accordance with cGMP standards.
This makes sure that every batch has the same high level of purity and quality as a medicinal product.
Our company manufactures this with high security and responsibility.
Therapeutic Applications
Type of drug: Anti-cancer and chemotherapy drug.
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Lung cancer (NSCLC)
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Pancreatic Cancer
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Breast Cancer
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Cancer of the Ovaries
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Bladder Cancer
Specification Parameters
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CAS Number: 122111-03-9
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Therapeutic Class: Antineoplastic Agent (Antimetabolite)
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Molecular formula: C9H12F2N3O4·HCl.
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Molecular weight: around 314.66 g/mol (hydrochloride salt)
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Appearance: Crystalline powder that is white to off-white
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Assay (HPLC): 98.0% to 102.0% on a dry basis
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Water Content: No more than 1.0%
Packaging & Storage
Our packaging protects items while they are being sent, stored, and used.
It was made to match diverse rules and needs for how things work.
Packed in food-safe HDPE drums with seals that can display if they are touched or contaminated by anyone.
LDPE liners with two layers on the inside or aluminum foil bags
There is a detailed label on every package. It has the product name, batch number, net weight, Date of manufacture, date of expiration, storage conditions, and safety symbols on it.
Keep it in a cold, dry, and well-ventilated place at 2°C to 8°C.
Keep out of the sun, humidity, and changes in temperature.
If not using, then the packet should be properly closed.
If it is stored properly, it will last for 24 months from the date it was made.
Why Choose Us
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Manufacturing that meets all rules
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Manufactured at facilities that are certified by WHO-GMP and ISO 9001:2015 Following ICH Q7, EU-GMP, and other global quality requirements
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Better Quality and Dependability
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Every batch goes through a full set of analytical tests.
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Complete traceability with confirmed cleaning and cross-contamination procedures
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Help and documentation for regulations
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Help with filing US-DMF, EU-DMF, and CAN-DMF
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Full dossier: COA, MSDS, TSE/BSE certification, Stability Reports, and Method of Analysis
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Focus on customization and working together
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Specifications, packing, and documentation that can be changed
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Long-term contracts come with dedicated technical support and a reliable supply chain.