1. Product Identification

Chemical & Structural Data

Parameter	Specification
Chemical Name	2′-Deoxy-2′,2′-difluorocytidine monohydrochloride (β-isomer)
IUPAC Name	4-Amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one hydrochloride
CAS Number	122111-03-9 (HCl salt) / 95058-81-4 (free base)
Molecular Formula	C₉H₁₁F₂N₃O₄ · HCl
Molecular Weight	299.66 g/mol (HCl salt)
Appearance	White to off-white crystalline powder (lyophilized form available)

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2. Quality Specifications

Release Testing (USP <211> & ICH Q6A Compliant)

Parameter	Specification	Test Method
Identity (FTIR/HPLC)	Conforms to reference standard	USP <197K>
Assay (HPLC-UV)	98.0–102.0% (anhydrous basis)	Reverse-phase HPLC
Water Content (KF)	≤1.0%	Karl Fischer
Optical Rotation	+48° to +54° (c=1 in water)	Polarimetry
pH (10 mg/mL solution)	2.5–3.5	Potentiometric
Residual Solvents	Meets ICH Q3C Class 2 limits	GC-HS
Endotoxins	<0.5 EU/mg	LAL Test

Impurity Profile

Impurity	Limit (% w/w)	Remarks
Gemcitabine α-anomer	≤0.5%	Diastereomer (pharmacologically inactive)
Gemcitabine β-anomer	≤0.5%	Impurity from synthesis
Uracil degradation products	≤0.3%	Hydrolysis byproduct
Unknown impurities	≤0.1% each	HPLC-UV (290 nm)

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3. Physicochemical Properties

Physical & Stability Data

Property	Value	Conditions
Melting Point	252–258°C (dec.)	DSC analysis
Solubility	≥50 mg/mL in water (clear solution)	25°C
Partition Coefficient (LogP)	-1.3	Octanol/water
pKa Values	3.6 (acidic), 9.2 (basic)	Potentiometric
Photostability	Light-sensitive (store in amber glass)	ICH Q1B validated

Note: Aqueous solutions are stable for 24 hours at 25°C, but should be stored at 2–8°C post-reconstitution.

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4. Product Applications

FDA-Approved Indications

✓ Pancreatic Adenocarcinoma (monotherapy: 1000 mg/m² weekly)
✓ Non-Small Cell Lung Cancer (NSCLC) (with cisplatin)
✓ Bladder Cancer (second-line)
✓ Metastatic Breast Cancer (with paclitaxel)

Dosage Form Compatibility

Formulation	Concentration Range	Notes
IV Injection	10–40 mg/mL	Compatible with 0.9% NaCl
Lyophilized Powder	38 mg/vial (1 g/m² equivalent)	Reconstitutes in 5–25 mL sterile water
Liposomal Encapsulation	Enhanced delivery systems	Improved tumor targeting

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5. Packaging & Storage

Available Configurations

Format	Primary Packaging	Stability Data
R&D (1–10 g)	Amber glass vial, N₂ flush	36 months at 2–8°C
Clinical (50–500 g)	Double PE bag, desiccant	24 months at controlled RT
Bulk (1–10 kg)	HDPE drum, Al-foil liner	12 months at -20°C (lyophilized)

Critical Storage Conditions

• Temperature: 2–8°C preferred (≤25°C short-term allowed)
• Humidity: ≤60% RH (desiccant required)
• Light Protection: Amber glass or opaque packaging mandatory
• Shelf Life: 24–36 months (validated per ICH Q1A)

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6. Safety & Regulatory

GHS Hazard Classification

⚠ Danger – Acute Toxicity (Oral, Cat 3) | Skin Sensitization (Cat 1) | Target Organ Toxicity (Cat 2)

Handling Precautions

• Use cytotoxic precautions (gloves, goggles, lab coat)
• Avoid inhalation (always handle in fume hood)
• Chemical waste must be incinerated at >1000°C

Regulatory Approvals

• US FDA NDA: NDA 020509 (Gemzar® Reference)
• EMA EPAR: Centralized Procedure No. EMEA/H/C/000273
• Japanese PMDA: Approved (JP XVII Monograph 2023)

First Aid Measures

• Eye Contact: Rinse immediately (15 min)
• Skin Contact: Wash thoroughly with soap
• Ingestion: Seek medical attention (antidote unknown)

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Technical Support & Customization

Available Services

✓ Analytical Method Development (HPLC/UPLC)
✓ Stability Studies (ICH Q1A accelerated & long-term)
✓ Salt/Polymorph Screening (HCl vs. free base)
✓ Lyophilization Support (cycle optimization)

Supply Chain Assurance

• Dual-source manufacturing (EU + US FDA-inspected sites)
• Just-in-time delivery with cold-chain logistics