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99% L-5-Methyltetrahydrofolate Calcium
Nanjing Gemsen
CAS 151533-22-1
Introduction：
Product name | L-5-Methyltetrahydrofolate Calcium |
Synonyms | methylfolate |
Appearance | White to light yellow crystalline powder,odorless |
Purity | 99% L-5-Methyltetrahydrofolate Calcium |
MOQ | 1 KG |
L-5-Methyltetrahydrofolate Calcium (L-5-MTHF-Ca) is the biologically active form of vitamin B9 (folate). Unlike synthetic folic acid, which requires metabolic conversion, this premium calcium salt (also known as CalciumLevomefolate or Metafolin®) is immediately available for the body. It is especially valuable for individuals with genetic variations (e.g., MTHFR polymorphisms) that may impair folate metabolism. The calcium conjugate form enhances water solubility and bioavailability while providing exceptional stability for formulations. As the naturally occurring folate form in foods, it offers a direct and efficient alternative to conventional folic acid.
Specification:
| Items | Specifications | Methods | |
| 1. Appearance | White to light yellow crystalline powder,odorles | Visual | |
| 2. Identification | Infrared detection | IR | |
Calcium detection | USP43 | ||
The retention time of HPLC main peak was in line with the standard | USP43 | ||
| 3. Content (on dried basis) | 95.0%~102.0% | USP43 | |
| 4. Water | 6.0%~17.0% | USP43 | |
| 5. Calcium (on dry basis) | 7.0%~8.5% | USP43 | |
6. Impurities | 4-aminobenzoyl-glutamic acid | ≤0.5% | USP43 |
4-α-Hydroxy-5-methyltetrahydrofolic acid | ≤1.0% | USP43 | |
(6S,R)-Mefox | ≤1.0% | USP43 | |
Tetrahydrofolic acid | ≤0.5% | USP43 | |
7,8-Dihydrofolic acid | ≤0.5% | USP43 | |
Folic acid | ≤0.5% | USP43 | |
5,10-methylenetetrahydrofolic acid | ≤0.5% | USP43 | |
5-methyltetrahydrop teroic acid | ≤0.5% | USP43 | |
| Dimethyltetrahydrofolic acid | ≤0.15% | USP43 | |
Total impurities | ≤2.5% | USP43 | |
| 7. Heavy Metals | ≤20 mg/kg | USP43 | |
| 8.Elemental Impurities | Plumbum | ≤1.0 mg/kg | USP43 |
Arsenic | ≤1.5 mg/kg | USP43 | |
Mercury | ≤1.5 mg/kg | USP43 | |
Cadmium | ≤1.5 mg/kg | USP43 | |
| Boron | ≤50 mg/kg | USP43 | |
| Platinum | ≤10 mg/kg | USP43 | |
| Chloride | ≤0.5% | USP43 | |
9. Residual Solvents (Ethanol) | ≤0.5% | USP43 | |
| 10. D-5-methyltetrahydrofolic Acid | ≤1.0% | USP43 | |
| 11. Microbial Limits | Total aerobic bacteria | ≤500 CFU/g | USP43 |
Total number of mold and yeast | ≤50 CFU/g | USP43 | |
Salmonella | Non-detectable | USP43 | |
Escherichia coli | Non-detectable | USP43 | |
Staphylococcus aureus | Non-detectable | USP43 | |
Pseudomonas aeruginosa | Non-detectable | USP43 | |
Candida albicans | Non-detectable | USP43 | |
Clostridia | Non-detectable | USP43 | |
Application
1. Healthcare Products
With the growing demand for nutritional supplements to support daily nutritional balance, L-5-Methyltetrahydrofolate Calcium, as the biologically active form of folate, is widely incorporated into healthcare product formulations for its direct metabolic availability. It serves as a supplementary nutritional ingredient to meet the body’s folate requirements.
-Bulk powder: Suitable for large-scale production of dietary supplements, easily mixed with other raw materials such as vitamins, minerals, and botanical extracts;
-Granules: Convenient for direct encapsulation or sachet packaging, facilitating portability and dosage control for end users;
-Microcapsule powder: Enhanced oxidative stability and dispersion properties, adaptable to various formulation types including effervescent tablets, chewables, and oral powders;
-Direct compression grade: Particularly suited for tablet manufacturing, ensuring uniform content distribution and consistent hardness without complex processing steps.
2. Food Industry
As consumers pursue healthier food options, adding natural nutritional components has become a key trend in food processing. L-5-Methyltetrahydrofolate Calcium, with its good stability and nutritional value, is used as a nutritional enhancer to enrich the folate profile of common foods.
-Cereal products (breakfast cereals, bars): Incorporated during processing to fortify folate content without affecting taste or texture;
-Beverages (fruit juices, functional drinks): Utilized in soluble powder or microcapsule form to enhance nutritional diversity while maintaining product clarity and flavor;
-Dairy products: Added to milk, yogurt, and powdered milk products to complement naturally occurring folates, improving product nutritional composition.
3. Maternal and Infant Nutrition
Maternal and infant nutrition requires strict compliance with safety and nutritional balance standards, with folate being an essential nutrient for normal growth and development during gestation and early life. L-5-Methyltetrahydrofolate Calcium, when meeting relevant safety thresholds, is used as a supplementary nutritional ingredient in products for this population.
-Prenatal and postpartum supplements: Added in appropriate proportions to support increased folate needs during pregnancy and lactation, compatible with other nutritional components such as iron, vitamin B12, and DHA;
-Infant formula milk powder: Formulated as the folate source in powdered infant formulas, providing a folate profile that closely resembles that found in human breast milk;
-Nutritional supplements for infants and young children: Prepared into soluble powders or microcapsules for easy mixing with milk or complementary foods, ensuring convenient intake.
4. Medical Nutrition
Medical nutrition products require ingredients with reliable bioavailability, stability, and compatibility with specialized formulations. L-5-Methyltetrahydrofolate Calcium, with its direct metabolic pathway and consistent quality characteristics, serves as a nutritional component in certain medical nutrition applications.
-Enteral formulas: Used as a folate source in liquid nutrition products designed for individuals with specific dietary management needs;
-Specialized dietary products: Incorporated into formulations where predictable nutrient delivery is required, supporting consistent nutritional intake;
-Oral nutritional supplements: Added to ready-to-drink or powder formats for use in clinical or home care settings.
5. Advanced Formulation Systems
Modern product development increasingly demands ingredients that perform reliably across diverse delivery formats. L-5-Methyltetrahydrofolate Calcium offers formulation flexibility beyond conventional tablet and capsule applications.
-Chewables and gummies: Compatible with processing conditions requiring heat and moisture management, maintaining stability throughout manufacturing;
-Liquid formulations: Water-soluble characteristics enable uniform dispersion in syrups, drops, and liquid nutritional products;
-Multi-layer and combination tablets: Compatible with other active ingredients such as B-complex vitamins, allowing for integrated product designs;
-Stick packs and single-dose sachets: Microencapsulated or granular forms provide moisture protection and dosage accuracy for on-the-go formats.
Q&A
Q1: What is the key difference between L-5-Methyltetrahydrofolate Calcium and folic acid?
A1: Folic acid is a synthetic form that must be converted into the active folate in the body. L-5-Methyltetrahydrofolate Calcium is already the biologically active form, bypassing this conversion step. This is particularly relevant for individuals with MTHFR gene polymorphisms, who may have reduced conversion capacity, ensuring they receive effective folate directly.
Q2: Is L-5-Methyltetrahydrofolate Calcium safe for use in supplements and foods?
A2: Yes. Its safety is supported by extensive studies, including genotoxicity, subchronic toxicity, and prenatal developmental toxicity tests in rats, which established a No Observed Adverse Effect Level (NOAEL) of 400 mg/kg bw/day. It is recognized as safe for its intended applications.
Q3: What are typical applications for this ingredient?
A3: It is versatile and used in dietary supplements (tablets, capsules, powders), prenatal vitamins, functional foods (fortified cereals, dairy, bars), infant formula, and medical nutrition products. Its stability and solubility suit various manufacturing processes.
Q4: How should L-5-Methyltetrahydrofolate Calcium be stored?
A4: For optimal stability, store in a sealed container under refrigeration (2–8°C), protected from light and moisture. An inert atmosphere such as nitrogen is recommended. Refer to the Certificate of Analysis for detailed guidelines.
Q5: Can it be used for long-term daily supplementation?
A5: Yes, within established intake levels. Typical daily doses range from 200 to 1000 μg for maintaining adequate folate levels, though specific products may vary. GEMSEN recommends consulting a healthcare professional or following local regulations for appropriate use.
Q6: What formulation advantages does the calcium salt form offer?
A6: The calcium salt enhances oxidative stability and water solubility, improving bioavailability and shelf life. It ensures consistent performance in finished products, making it a preferred choice for quality-focused manufacturers.
