What is Melatonin Bulk Powder?
Chemically referred to as N-acetyl-5-methoxytryptamine (CAS: 73-31-4), Melatonin Bulk Powder is a high-purity, white crystalline powder commonly used by clients as an initial raw material in the dieting supplement industry, nutraceutical, as well as compounding pharmacy markets. This synthetic additive requires manufacturers to create specific formulas dedicated to the maintenance of the natural process of rest and repose by the body. Bulk powder form allows the greatest freedom of formulation as the partners can produce an extensive range of finished products such as capsules, tablets, soft gels, liquid solutions, chewables, and tailored powder mixes. The fact that it is a fine powder is suitable in terms of blending and manufacturing operations carried out by large-scale commercial blending and production processes, allowing the control of dosage and the uniformity of batches. It is used to form proprietary wind-down or comprehensive evening support formulas in combination with other complementary ingredients, including Magnesium, L-theanine, Valerian Root, and botanicals, to develop individual-label brands. Being a key component, a consistent and approved bulk supply will be crucial to the contract manufacturers and the already known brand of supplement to fulfill the demand of the market and to sustain production of their retail products without interruptions.

COA
| Item | Specification | Result | Test Method |
| Appearance | White to off-white crystalline powder | Conforms | Visual |
| Odor | Characteristic | Conforms | Organoleptic |
| Assay (Purity) | ≥ 98.0% | 98.60% | HPLC |
| Identification | Positive | Positive | HPLC / IR |
| Loss on Drying | ≤ 0.5% | 0.18% | USP <731> |
| Residue on Ignition | ≤ 0.1% | 0.05% | USP <281> |
| Heavy Metals (Pb, As, Cd, Hg) | ≤ 10 ppm | < 10 ppm | ICP-MS |
| Lead (Pb) | ≤ 3 ppm | 0.52 ppm | ICP-MS |
| Arsenic (As) | ≤ 2 ppm | 0.21 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 1 ppm | 0.05 ppm | ICP-MS |
| Mercury (Hg) | ≤ 0.1 ppm | ND | ICP-MS |
| Residual Solvents | Meets USP <467> | Conforms | GC |
| Particle Size | 100% pass 80 mesh | Conforms | Sieve Test |
| Bulk Density | 0.40 – 0.60 g/mL | 0.48 g/mL | USP Method |
| Tapped Density | 0.60 – 0.80 g/mL | 0.72 g/mL | USP Method |
| Microbiological Tests | |||
| Total Plate Count | ≤ 1,000 CFU/g | < 100 CFU/g | USP <2021> |
| Yeast & Mold | ≤ 100 CFU/g | < 10 CFU/g | USP <2021> |
| E. coli | Negative | Negative | USP <2022> |
| Salmonella | Negative | Negative | USP <2022> |
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Mechanism of Action
The action mode of Melatonin Powder, N-acetyl-5-methoxytryptamine, is mainly two different pharmacological and molecular pathways, which makes it a molecule of great interest in the implementation of various products.
Its main mechanism involves the ability to act as a ligand of high-affinity G protein-coupled receptors, namely Melatonin Receptor 1 (MT1) and Melatonin Receptor 2 (MT2). These receptors are found in almost all tissues, and they are predominantly coupled with Gi/o proteins. The stimulation of the MT1 and the MT2 causes cells to inhibit adenylyl cyclase, which lowers the levels of cyclic AMP (cAMP) in the cells. This transduction cascade plays an important role in the regulation of various physiological activities at the cellular level, such as in regulation of biological rhythms and other processes in the body.
Its second important activity is that of a potent non-receptor-mediated direct and indirect antioxidant that is of great effect. It is relatively lipophilic and hydrophilic, and as such, it can easily penetrate all the compartments of the cell, such as the mitochondria. It is a strong scavenger of a number of Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS). Moreover, it increases the cellular antioxidant defense system in a non-direct, indirect manner by inducing the expression of endogenous antioxidant enzymes. This follow-up of action, i.e., a receptor-mediated signaling and a pleiotropic free radical scavenging role, highlights its application as a multi-purpose raw material in superior formulations.
Process
1. Starting Material Synthesis/Acylation:
The procedure usually starts with Tryptamine or 5-methoxytryptamine. The most notable one is the acylation of the amine group (N-H) with acetylating agent, e.g., acetic anhydride, to produce N-acetylserotonin (a precursor), which is in effect the introduction of the characteristic N-acetyl group.
2. Methoxylation/Methylation:
In case the precursor is not already methoxylated, a very essential methylation reaction is done. This reaction involves a methylating agent to insert a methoxy group (O-CH3) at the 5 position of the indole ring, thereby completing the structural synthesis process and giving rise to N-acetyl-5-methoxytryptamine (Melatonin).
3. Reaction Quenching & Isolation:
After the synthesis is completed, the reaction is well quenched to deactivate the residual reagents and halt the chemical reaction. This crude melatonin product is then usually recovered from the solution through controlled precipitation by varying such factors as temperature or solvent mixture.
4. Purification (Crystallization):
This is a very important step towards attaining the high purity needed to make bulk sales. The raw solid is dissolved and recrystallized under discriminating temperature conditions. This causes the pure melatonin to choose to crystallize out, leaving most chemical impurities in the mother liquor.
5. Drying and Milling:
The crystals are purified, and filtration processes are used to extract the purified crystals, which are then dried under vacuum in order to remove all traces of solvents and moisture, in order to comply with the high safety standards. The resulting product is then usually milled (micronized) to provide a fine, uniform particle size that is necessary to provide uniform blending in the final finished product manufacturing.
6. Quality Control & Packaging:
The finished Pure Bulk Melatonin is then subjected to extensive tests according to the cGMP requirements. Testing will also involve checking identification, assay purity 98% and heavy metals, microbial contaminants, and solvent remnants limits. After being certified by a Certificate of Analysis (COA), the final product is packed in bulk packaging, e.g,. in 25 kg fiber drums, to be distributed.

Suitable For
1. The Adult Working-Age Population:
Being the most affected by lifestyle-related sleeping disorders, stressful work schedules, and more screen time, this segment requires high-volume needs on the convenience of Melatonin Supplement dosage forms, such as fast-dissolve pills, gummies, and liquid shots, to aid in creating a routine evening routine.
2. Travelers and Shift Workers:
These people need special formulations to overcome temporary circadian rhythm problems, including the recovery of jet lag or problems of rotating night and day shifts. Immediate-release and controlled-release technologies are offered to this segment by manufacturers.
3. The Aging Population (Geriatric Consumers):
This is the ageing population of the world, which needs efficient solutions to the natural changes of their age cycles. Products that are finished targeting this segment are usually based on convenience to consumption, e.g., liquids or chewables, with specific, lower dosage and a powerful interest in quality consistency.
4. The Wellness and Functional Food Market:
This is a fast-growing segment that involves consumers who want to add some functional ingredients to their daily food. The manufacturers, in this case, therefore, provide material to diversify the product into functional beverages, specialty food mixes, as well as combination supplements that include synergistic ingredients such as L-Theanine and Magnesium.
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