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Methylfolate Levomefolate Calcium 151533-22-1
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Item | Specification | Test Method |
Active Ingredient | ||
Assay(On dry basis) | 95.0% ~ 102.0% | HPLC |
L-5-MTHF | 72.0% ~ 82.0% | Calculation |
D-5-Methylfolate | NMT 1.0% | HPLC |
Calcium(On dry basis) | 7.0% - 8.5% | USP 40 |
Total Related Compounds | NMT 2.5% | HPLC |
4-Aminobenzoylglutamic Acid | NMT 0.5% | HPLC |
4a-Hydroxy-5-Methyltetrahydrofolic Acid | NMT 1.0% | HPLC |
(6S)-Mefox | 1.0 (sum of 6R and 6S)% | HPLC |
Tetrahydrofolic Acid | NMT 0.5% | HPLC |
7,8-Dihydrofolic Acid | NMT 0.5% | HPLC |
Folic Acid | NMT 0.5% | HPLC |
5,10-Methylenetetrahydrofolic Acid | NMT 0.5% | HPLC |
5-Methyltetrahydropteroic Acid | NMT 0.5% | HPLC |
Dimethyltetrahydrofolic Acid | NMT 0.15% | HPLC |
Enantiomeric Impurity (D-5-methyltetrahydrofolate) | NMT1.0% | HPLC |
Physical Control | ||
Appearance | White to light yellowish crystalline powder | Visual |
Identification | The retention time of the principle peak should conforms with standard | HPLC |
Solubility in water | Water soluble | Organoleptic |
Water Content | 6% - 17.0% | Karl Fischer |
Particle Size | NLT 90% pass 80mesh | USP 40 |
Bulk Density | NLT 0.2g/ml | USP 40 |
Residue Solvents | Ethanol: NMT 5000ppm | USP<467> |
Chemical Control | ||
Platinum | NMT 10ppm | USP 40 |
Boron | NMT 50ppm | USP 40 |
Chloride | NMT 0.5% | USP 40 |
Heavy Metals | NMT 10ppm | USP<231> |
Lead (Pb) | NMT 1.0ppm | IPC-MS |
Arsenic (As) | NMT 1.0ppm | IPC-MS |
Cadmium (Cd) | NMT 0.5ppm | IPC-MS |
Mercury (Hg) | NMT 0.1ppm | IPC-MS |
Microbiological Control | ||
Total Plate Count | NMT 1,000cfu/g | USP 40 |
Yeast & Mold | NMT 100cfu/g | USP 40 |
Salmonella | Negative | USP 40 |
E.Coli | Negative | USP 40 |
Staphylococcus Aureus | Negative | USP 40 |
Pseudomonas aeruginosa | Negative | USP 40 |
Candida albicans | Negative | USP 40 |
Clostridia | Negative | USP 40 |
About us
Nudlehealth is an international company with a presence in multiple countries, it’s Headquarters are based in Chengdu under Nudlehealth Biotechnology Limited.
Based on our business philosophy of focus, efficiency, dedication and reputation, Nudlehealth is committed to offering cutting-edge products and services with strong competitiveness and creativity, aiming to establish ourselves as one of the most reputable companies in the industry.
Chengdu Nudlehealth Biotechnology Limited is a high-tech enterprise dedicated to the development of: high-end pharmaceutical intermediates, health care raw materials, extraction of natural products, chemical raw materials, chemical processes and chemical drugs. The core team is composed of Dr. Returnees, whom was an executive at a global fortune 500 company, whilst our technical and marketing directors were all part of listed large foreign trade companies. Members have long been engaged in relevant research, management and market development, and have advanced technical concepts, rich management experience and market expansion experience coupled with our complete system from R&D to marketing. In addition to the company's cutting-edge technology and experienced team, the company also attaches great importance to cooperation with domestic and foreign research institutes, and has now reached strategic cooperation with Shanghai Jiaotong University, Sichuan University and other universities.
Nudlehealth Biotechnology (PTY) Limited is based in Johannesburg, South Africa. The team has been rooted in Africa for more than 30 years and we focus on extracts of natural plants in Africa. The main products are Marula oil, hemp oil and other natural product extracts.
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