Pharmaceutical-Grade Levoleucovorin Calcium CAS 80433-71-2

Key Features

✔ Optically Pure Isomer (>99% enantiomeric excess)
✔ FDA-Approved Drug Substance (USP/EP Compliant)
✔ Ultra-Low Endotoxin (<0.25 EU/mg)
✔ Ready-to-Sterilize Powder & Prefilled Syringes
✔ GMP Manufacturing with DMF Filed

Batch-specific CoA available on request.

Levoleucovorin Calcium (CAS 80433-71-2) is the pharmacologically active (6S)-isomer of leucovorin, demonstrating enhanced efficacy in folate-dependent therapies. As the preferred form for oncology applications, it provides superior metabolic activity compared to racemic mixtures.

1. PRODUCT IDENTIFICATION

Parameter	Specification
IUPAC Name	Calcium (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-5,6,7,8-tetrahydro-1H-pteridin-6-yl]methylamino]benzoyl]amino]pentanedioate
CAS Number	80433-71-2
Molecular Formula	C₂₀H₂₁CaN₇O₇
Molecular Weight	511.50 g/mol
Therapeutic Category	Antineoplastic Adjunct/Folate Analog

2. QUALITY SPECIFICATIONS

Test Parameter	USP	EP	Internal
Enantiomeric Purity	≥98.5% ee	≥99.0% ee	≥99.5% ee
Assay (HPLC)	97.0-103.0%	98.0-102.0%	99.0-101.0%
Single Unknown Impurity	≤0.5%	≤0.3%	≤0.1%
Endotoxin	<0.5 EU/mg	<0.25 EU/mg	<0.1 EU/mg

3. PHYSICOCHEMICAL PROPERTIES

Property	Specification
Specific Rotation	+15° to +18° (c=1 in 0.1N NaOH)
pH (10% Solution)	6.8-7.8
Water Content (KF)	≤8.0%
DSC Peak	245-255°C (decomposition)

4. THERAPEUTIC APPLICATIONS

FDA-Approved Indications:

• High-Dose Methotrexate Rescue
• 5-FU Combination Therapy for Colorectal Cancer

Emerging Uses:

• Targeted Cancer Therapies
• Radiosensitization Protocols

5. SPECIALIZED PACKAGING

Format	Features
Sterile Lyophilized	50mg/vial (10-vial trays)
Nitrogen-Purged Bottles	500g (HDPE with desiccant)
Custom Bioreactor Systems	Bulk API for continuous manufacturing

6. STABILITY PROFILE

✓ Long-Term: 24 months at 2-8°C
✓ Accelerated: 6 months at 25°C/60% RH
✓ Photostability: Complies ICH Q1B

7. COMPLIANCE DATA

✔ Regulatory Submissions: US DMF #033245, EU ASMF
✔ GMP Certificates: FDA-EUPIC, Japan PMDA
✔ Animal-Free Certification: EC 2020/439 Compliant

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)
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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).

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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.