Pharmaceutical-Grade Folinic acid CAS No.：58-05-9

Key Features

✔ Multiple Pharmacopeia Grades (USP/EP/JP)
✔ High Purity (≥98% by HPLC)
✔ Versatile Forms Available (Calcium salt/Acid form)
✔ Low Endotoxin Options (<0.5 EU/mg)
✔ GMP Manufacturing Compliance
✔ Stable Shelf Life (36 months when properly stored)

Batch-specific CoA available on request.

Folinic Acid (CAS 58-05-9), also known as leucovorin, is a pivotal pharmaceutical intermediate and active ingredient crucial for methotrexate rescue therapy and 5-FU chemotherapy potentiation. Available in various purity grades including USP, EP and JP standards. Suitable for injectable formulations and oral dosage development.

1. PRODUCT IDENTIFICATION

Parameter	Specification
Chemical Name	(2S)-2-[[4-[(2-amino-5-formyl-4-oxo-5,6,7,8-tetrahydro-1H-pteridin-6-yl)methylamino]benzoyl]amino]pentanedioic acid
CAS Number	58-05-9
EC Number	200-376-2
Molecular Formula	C₂₀H₂₃N₇O₇
Molecular Weight	473.44 g/mol
Regulatory Status	DMF/ASMF available

2. QUALITY SPECIFICATIONS

Test Parameter	USP-NF	EP 10.0	JP 18
Assay (HPLC)	97.0-102.0%	98.0-102.0%	98.0-102.0%
Related Substances	≤2.0% total	≤1.5% total	≤1.5% total
Water Content	≤8.5%	≤8.0%	≤8.0%
Residual Solvents	Complies ICH Q3C	Complies ICH Q3C	Complies ICH Q3C
Sterility (when applicable)	USP <71>	EP 2.6.1	JP 4.06

3. PHYSICOCHEMICAL PROPERTIES

Property	Specification
Appearance	Yellowish crystalline powder
Solubility	Sparingly soluble in water, soluble in dilute alkali solutions
pH (1% solution)	6.0-7.5
Optical Rotation	+14° to +20° (c=1 in 0.1N NaOH)
Melting Point	238-242°C (dec.)

4. PRODUCT APPLICATIONS

Pharmaceutical Applications:

✔ Antidote for methotrexate toxicity
✔ Adjuvant in 5-fluorouracil chemotherapy
✔ Treatment of folate deficiency

Research Applications:

✔ Biochemical research
✔ Cell culture studies
✔ Reference standard preparation

5. PACKAGING & STORAGE

Available Packaging Options:

✔ 1g/5g sterile vials
✔ 25g/100g amber glass bottles
✔ Custom packaging available

Storage Conditions:

➤ Temperature: 2-8°C (refrigerated)
➤ Protection: From light and moisture
➤ Shelf Life: 36 months in original packaging

6. SAFETY & HANDLING

Precautionary Statements:

⚠ P264 - Wash hands thoroughly after handling
⚠ P280 - Wear protective gloves/eye protection

First Aid Measures:

➤ Eye Contact: Rinse cautiously with water for several minutes
➤ Skin Contact: Wash with plenty of soap and water
➤ Ingestion: Rinse mouth and seek medical advice

Disposal Considerations:

♻ Dispose of in accordance with local regulations

ADDITIONAL SERVICES AVAILABLE:

• Custom synthesis and packaging
• Regulatory support documentation
• Stability studies

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.

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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.

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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

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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.