99% High Purity USP Pharmacy Grade Gemcitabine hydrochloride Power with Best Price and Fast Delivery

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Chemical Profile and Structural Characteristics

Gemcitabine hydrochloride (CAS 122111-03-9) is a nucleoside analog and the hydrochloride salt of 2'-deoxy-2',2'-difluorocytidine. This fluorinated pyrimidine antimetabolite features a cytosine base attached to a difluorinated ribose sugar moiety, with the hydrochloride salt enhancing its stability and aqueous solubility. The compound presents as a white to off-white crystalline powder with a molecular weight of 299.66 g/mol for the free base and demonstrates high solubility in water, physiological saline, and slightly acidic solutions. Its unique difluoro modification at the 2' ribose position confers resistance to deamination while maintaining recognition by cellular nucleoside transporters and kinases.

Mechanism of Action and Pharmacological Activity

The compound requires intracellular activation through phosphorylation by deoxycytidine kinase to form gemcitabine diphosphate and triphosphate metabolites. Gemcitabine triphosphate incorporates into growing DNA strands, causing masked chain termination after the addition of one more deoxynucleotide, thereby inhibiting DNA synthesis and repair. Simultaneously, gemcitabine diphosphate inhibits ribonucleotide reductase, reducing cellular deoxynucleotide pools and further potentiating DNA synthesis inhibition. This dual mechanism results in dose-dependent cytotoxic effects specifically in rapidly dividing cells, with preferential activity against DNA replication processes.

Therapeutic Applications and Clinical Uses

Gemcitabine hydrochloride is approved for first-line treatment of locally advanced or metastatic pancreatic adenocarcinoma, non-small cell lung cancer, bladder cancer, and metastatic breast cancer. Clinical protocols typically administer the drug intravenously at 1000 mg/m² over 30 minutes weekly for up to 7 weeks, followed by a week of rest. Combination regimens with cisplatin, carboplatin, or nab-paclitaxel demonstrate enhanced efficacy in specific malignancies. Dose adjustments are required for patients with impaired hepatic or renal function, and careful hematological monitoring is essential throughout treatment cycles.

Formulation Development and Stability Considerations

We supply gemcitabine hydrochloride as a sterile lyophilized powder for reconstitution with 0.9% sodium chloride injection, producing a clear, colorless solution containing 38 mg/mL of gemcitabine base. The formulation maintains stability for 24 hours at controlled room temperature after reconstitution, with protection from light recommended. Technical data supports compatibility with common intravenous fluids and administration sets, along with comprehensive stability profiles under various storage conditions. The lyophilized form ensures extended shelf life while maintaining chemical integrity and sterility.

Quality Specifications and Analytical Controls

Our gemcitabine hydrochloride meets rigorous pharmacopeial standards with specifications including identification by HPLC and IR spectroscopy, assay requirement of 98.0-102.0%, and of related substances including the uracil analog and other process-related impurities. Critical quality attributes encompass sterility, bacterial endotoxins, particulate matter, and uniformity of dosage. Validated stability-indicating HPLC methods with UV detection ensure precise quantification and monitoring of degradation products throughout the product lifecycle under recommended storage conditions at 20-25°C.

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FAQ

Q1. Can I get a free sample?

We can send you a samll free sample, and you only need to pay for the shipping cost.

Q2. What is the HyperChem payment term?

T/T in advance
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Q3. What is HyperChem shipment policy?

Our policy is to strive for the quickest shipment time possible.

For ready stock samples, they are usually shipped within 3 working days after payment received.
For non-ready stock, please contact HyperChem sales team to negotiate.

Q4. What is HyperChem shipment term?

By Express  
FedEx  UPS  DHL  EMS                               
Fast: 3-7 days around, high cost, door to door service

By Air                                        
Suitable for more than 50kg 
Fast: 3-7 days, hight cost, port to port, professional broker needed 

By Sea
Suitable for more than 500kg      
Fast: 7-45 days, low cost, port to port, professional broker needed 

We will always attempt to utilize the quickest and most affordable way for customers to receive orders. And follow -up with customers via email for all shipment details as well as updated track information until it arrives without damage.

Q5. What HyperChem will provide after shipment?

For sample orders: 
After shipment is done, an timely email including:

1. Track details (Fedex /TNT/DHL/EMS Track number)
2. Packaging photo
3. COA, MSDS, etc
4. Dispatch date & Estimated arriving time
5. Shipping invoice

For commercial orders
A full set of shipment documents as well as package photos can be provided in scan-copy and original, to help customers complete the customs clearance process.

Company Profile

Established in 2013, Hyper Chem has exclusive tie-ups with leading manufacturers, supplying raw materials produced in GMP and ISO 9002 certified facilities, and provides high-quality ingredients and raw materials to cater to the requirements of our diverse range of clients.

Among them, our key client industrial sectors around the global are:

Pharmaceuticals
Nutrition Ingredients/ Dietary supplements
Cosmetic Ingredients
Food Ingredients
Veterinary API
Agriculture fertilizer
Custom Synthesis lab supply

HyperChem provides to its wonderful and honorable clients comprehensive purchasing and distribution services which ensure that we are delivering the right generic, raw, or customized product, make sure that we are delivering it at the right time, ensure that it is delivered in the specified amount, and in the right kind of packaging to clients and customers of all types of industries irrespective of their size of operation.