Folinic Acid Disodium (CAS: 163254-40-8) – cGMP Grade – Trustworthy and Experienced Chemical Manufacturer in China

Folinic Acid Disodium (CAS: 163254-40-8) – cGMP Grade

Key Features

◆ Ready-to-Use Folate – Immediate activity without metabolic activation
◆ High-Solubility Salt – 2.5× more soluble than free acid form (120 mg/mL)
◆ Therapeutic Grade – USP/EP compliance with ≤0.5 EU/mg endotoxin
◆ Cold Chain Stability – 5-year shelf life at -20°C

Batch-specific CoA available on request.

1. Critical Quality Attributes

Quality Specifications (USP <1185>)

Parameter	Specification	Method
Appearance	Yellow to orange crystalline powder	Visual inspection
Identity (HPLC)	Retention time matches reference standard	USP <621>
Purity (HPLC)	97.0-103.0%	Reverse-phase HPLC
Water Content	≤8.0% w/w	Karl Fischer
pH (10% aq.)	7.0-8.5	Potentiometric
Optical Rotation	+14° to +17° (c=1 in 0.1M HCl)	Polarimeter
Heavy Metals	≤10 ppm	ICP-MS

Impurity Profile

Impurity	Specification
Total Related Substances	≤2.0%
Individual Unknowns	≤0.5%
Diastereomer (6R-form)	≤0.3%

2. Structural & Physical Data

Property	Specification
Molecular Formula	C₂₀H₂₁N₇Na₂O₇
Molecular Weight	517.42 g/mol
CAS	163254-40-8
Solubility	120 mg/mL in water
pKa Values	3.2, 4.9, 10.1

3. Application Specifications

Pharmaceutical Use Cases

✔ Chemotherapy Adjuvant (Methotrexate rescue: 15-100 mg/m² IV)
✔ 5-FU Potentiation (Leucovorin regimens in CRC)
✔ Folate Replacement (Bypasses DHFR mutations)

Compatible Formulations

Dosage Form	Concentration Range
IV Solution	10-50 mg/mL (pH 7.8-8.2)
Oral Tablet	15-25 mg (with MCC/starch)

4. Stability & Packaging

Packaging Options

Configuration	Stability Data
Research (1-10g)	Amber glass vial (60 mo @ -20°C)
Clinical (50-500g)	PE bag + desiccant (36 mo @ 2-8°C)
Bulk (1-10kg)	Al-foil drum (24 mo @ controlled RT)

Storage Conditions

• Photostability: Protect from light (validated per ICH Q1B)
• Reconstituted Solution: Stable 24h at 25°C (NS/PBS)

5. Compliance & Safety

◆ Regulatory Status:

FDA-approved NDA for leucovorin
EP 10.0 monograph 01/2023:2448

◆ Safety Profile:

Non-mutagenic (Ames negative)
LD50 >2000 mg/kg (oral, rat)

First Aid: Eye rinse (15 min), skin wash with soap

Quality Commitment

✓ Batch-specific CoA with HPLC chromatogram
✓ Full ICH stability data packages available
✓ cGMP manufacturing with ISO 13485 certification

Request samples with Technical Dossier (includes DMF references)

▲ Note: Specialize in lyophilized formulations - Ask about our ready-to-sterile-filter solutions

This revision:

Properly positions Appearance as the first QC parameter
Groups related quality attributes together
Enhances readability with application-focused tables
Maintains regulatory rigor while improving scannability

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.