Gemcitabine (CAS 95058-81-4) – Pharmaceutical Grade Antimetabolite – Trustworthy and Experienced Chemical Manufacturer in China

Gemcitabine (CAS 95058-81-4) – Pharmaceutical Grade Antimetabolite

Key Features

• Potent Anticancer Agent – FDA-approved for pancreatic, lung, breast, and ovarian cancers
• Mechanism of Action – Nucleoside analog that inhibits DNA synthesis
• High Purity Grade – ≥99.0% by HPLC, manufactured under cGMP
• Enhanced Stability – Lyophilized form available for improved shelf life
• Global Standards Compliance – Meets USP, EP, and JP pharmacopeia requirements

Batch-specific CoA available on request.

1. Product Identification

Chemical Specifications

Property	Specification
Chemical Name	2'-Deoxy-2',2'-difluorocytidine
IUPAC Name	4-Amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
CAS Number	95058-81-4
Molecular Formula	C₉H₁₁F₂N₃O₄
Molecular Weight	263.20 g/mol
EINECS Number	419-430-6

Structural Characteristics

• Chirality: Contains two stereocenters • Solvation: Typically exists as monohydrate • Salt Form: Hydrochloride salt available (CAS 122111-03-9)

2. Quality Specifications

Analytical Parameters

Parameter	Specification	Test Method
Appearance	White to off-white crystalline powder	Visual
Identification (HPLC)	Retention time corresponds to reference standard	USP <621>
Assay (HPLC)	98.0-102.0%	Reverse-phase HPLC
Water Content	≤1.0% (anhydrous basis)	Karl Fischer
Optical Rotation	+45° to +50° (c=1 in water)	Polarimetry
pH (10 mg/mL)	2.5-3.5 (hydrochloride salt)	Potentiometric
Related Substances	Total impurities ≤2.0%	HPLC-UV

Impurity Profile

Impurity	Limit
Gemcitabine α-anomer	≤0.5%
Gemcitabine β-anomer	≤0.5%
Uracil derivatives	≤0.3%
Other unspecified	≤0.2% each

3. Physicochemical Properties

Physical Characteristics

Property	Value	Conditions
Melting Point	290-300°C (dec.)	DSC
Solubility	50 mg/mL in water	25°C
LogP	-1.3	Octanol/water
pKa	3.6 (acidic), 8.2 (basic)	Potentiometric

Stability Data

• Solution Stability: pH-dependent; most stable at pH 2-4 • Photostability: Sensitive to light; store protected • Thermal Stability: Decomposes above 200°C

4. Product Applications

Therapeutic Uses

✓ First-line Treatment for pancreatic adenocarcinoma ✓ Combination Therapy with cisplatin for NSCLC ✓ Breast Cancer (with paclitaxel) ✓ Ovarian Cancer (recurrent cases)

Pharmaceutical Formulations

• Injectable Solution: Typically 10-40 mg/mL concentrations • Lyophilized Powder: For reconstitution (38 mg/vial typical) • Liposomal Formulations: Enhanced delivery systems

5. Packaging & Storage

Packaging Options

Format	Description
Research Quantities	1g-10g in amber glass vials
Clinical Quantities	50g-500g in double PE bags
Bulk Quantities	1kg+ in sealed HDPE drums

Storage Conditions

• Temperature: 2-8°C (long-term), ≤25°C (short-term) • Humidity: ≤60% RH (with desiccant) • Light Protection: Amber containers required • Shelf Life: 36 months when properly stored

6. Safety & Handling

Regulatory Status

• FDA Approval: 1996 (initial approval) • EMA Approval: Centralized authorization • Major Pharmacopeias: USP, EP, JP monographs

Safety Information

• GHS Classification: Skin sensitization (Category 1), Target organ toxicity (Category 2) • Handling Precautions: Use appropriate PPE (gloves, goggles, lab coat) • First Aid Measures:

Eye contact: Flush with water for 15 minutes
Skin contact: Wash with soap and water
Ingestion: Seek medical attention immediately
Inhalation: Move to fresh air

Disposal

• Follow local regulations for cytotoxic waste • Incineration recommended

Technical Support

Available Documentation

Customization Options

• Particle size modification (micronization available) • Special packaging (nitrogen flush, sterile) • Excipient compatibility studies

Ordering Information

Minimum Order Quantity

• 1 gram (research quantities) • Commercial quantities negotiable

Lead Time

• Standard: 2-4 weeks • Rush service available

Note: All materials shipped with temperature monitoring and proper hazardous material documentation.

Product MOQ

We understand that your requirements vary across different stages, from R&D and pilot scale to commercial production. Therefore, we support both:

R&D Samples: We offer sample sizes from gram to kilogram scale to support your early-stage project evaluation.
Commercial Supply: We provide standard industrial packaging (e.g., 25kg drums, 200kg drums) and have a stable capacity for bulk supply.

For detailed information on the Minimum Order Quantity (MOQ) for a specific product or to discuss custom packaging solutions, please contact our sales team.

Our Customization Capabilities Include

We bridge the gap between your concept and a commercial-ready product. Our flexible manufacturing and expert R&D team empower us to deliver fully customized chemical solutions.

Custom Synthesis: We develop molecules from lab scale to industrial production.
Specification Adjustment: We modify purity, form, and other key parameters to fit your application.
Flexible Packaging: We provide custom packaging and labeling to streamline your supply chain.

Tell us your challenge. We’ll build the solution.

Large or Small Order

Sample and bulk orders are welcome.
Supplying from grams to tons. Inquire for pricing.
We treat every order with the same dedication, large or small.

Technical Downloads

Technical Data Sheet (TDS)
Safety Data Sheet (SDS)
Request Certificate of Analysis (CoA)
Request a Quote

Inquiry & Ordering Information

Submit Inquiry: Contact us with the Product/CAS No., Quantity, and Purity requirements.
Receive Quote: Our team will provide a formal quotation and lead time.
Place Order: Confirm by issuing an official Purchase Order (PO).

Questions? Contact Us anytime.

Custom Synthesis Service

Certified Quality Control

Shipping Order Track

Strict Confidentiality

VIP Customer Service

Reischbio provides confidential custom synthesis services, structured for innovative companies requiring unique and proprietary molecules. Our expert chemists leverage state-of-the-art reaction technologies to tackle complex, multi-step synthesis projects, from milligrams to multi-kilogram scale. Governed by strict IP protection protocols, we function as a seamless extension of your R&D team. Our agile project management and transparent communication ensure projects are delivered on-time and on-spec. With our bespoke chemistry solutions, we empower you to overcome scientific challenges, secure critical IP, and accelerate your path to innovation.