I. Basic Chemical Identification (Core Parameters)
- Common Names: Nicotinamide Riboside Malate, NR Malate, Nicotinamide Riboside Hydrogen Malate
- English Name: Nicotinamide Riboside Malate, Nicotinamide Riboside Hydrogen Malate (NRHM)
- CAS Registry Number: 2415659-01-5
- Molecular Weight: 388.33 Da
- Molecular Formula: C₁₅H₂₀N₂O₁₀
- Category: Fine chemical raw material, belonging to vitamin B3 (niacin) derivatives, and also a carboxylic acid derivative
- Core Characteristics: It is an oral active NAD+ precursor, which can increase the level of NAD+ in the body through metabolic pathways, activate SIRT1 and SIRT3 proteins, and has nutritional supplement and physiological activity-related characteristics.
II. Key Physicochemical Properties (Detailed Parameters)
- Appearance: White to off-white crystalline powder, no visible impurities, no obvious odor, uniform crystal form, no caking phenomenon
- Solubility: Easily soluble in purified water, normal saline and other aqueous solvents; soluble in polar organic solvents such as methanol and ethanol; slightly soluble in non-polar organic solvents; it is weakly acidic in aqueous solution, and the solution is clear and transparent without precipitation after dissolution.
- Stability: Stable under dark, sealed and dry environment; can be stored for a short time (1-3 months) at room temperature (25℃±2℃); long-term storage needs to avoid high temperature, humidity and strong light to prevent degradation.
- Melting Point: 158-162℃ (decomposition point), decomposition will occur when heated to the decomposition point, producing a small amount of nicotinamide by-products.
- Hygroscopicity: Slightly hygroscopic, easy to absorb moisture and agglomerate in an environment with relative humidity >60%, so the storage environment needs to be strictly controlled.
- Cosmetic Efficacy: It has skin conditioning and skin protection effects, and can be used as a raw material for skin care products to assist in improving skin state.
III. Synthesis Process and Process Control
A two-step synthesis method is adopted, with mature and controllable process, which can effectively ensure product purity and yield, and meet the requirements of fine chemical production specifications. The specific process and control points are as follows:
- Step 1: Preparation of Nicotinamide Riboside — Using nicotinamide and ribose as raw materials, under the action of a catalyst, a condensation reaction is carried out at 35-40℃ for 4-6 hours. The reaction end point is monitored by HPLC (conversion rate ≥98%), and high-purity nicotinamide riboside intermediate is obtained after purification and drying.
- Step 2: Malic Acid Complexation Reaction — Mix nicotinamide riboside and malic acid at a molar ratio of 1:1, carry out complexation reaction in anhydrous ethanol system, control the reaction temperature at 25-30℃, stir at a speed of 200-300r/min for 2-3 hours, and monitor the reaction progress by HPLC.
- Process Control Points: The water content of the reaction system must be strictly controlled (≤0.5%) to avoid affecting the complexation effect; the catalyst should be free of heavy metal residues to ensure that the heavy metal indicators of the finished product meet the standard; the drying temperature is controlled at 60-70℃, and the vacuum degree is -0.08~-0.10MPa to prevent product degradation or moisture absorption.
IV. Quality Standards and Detection Methods (Industrial/Scientific Research Grade)
The quality standards strictly comply with the relevant specifications of fine chemical raw materials and GMP requirements, divided into industrial grade and scientific research grade, with accurate and traceable detection methods:
- HPLC Purity: Industrial grade ≥98.0%, scientific research grade ≥99.0%; Detection conditions: Mobile phase is methanol-0.1% phosphoric acid aqueous solution (volume ratio 30:70), detection wavelength 260nm, flow rate 1.0mL/min.
- Key Impurity Control: Single impurity ≤0.5%, total impurity ≤2.0%, no obvious unknown impurities (content ≥0.1% need to be qualitatively confirmed).
- Routine Indicators: Moisture ≤8.0% (detected by Karl Fischer method); Heavy metals (calculated as Pb) ≤10ppm (detected by atomic absorption spectrophotometry); Ash ≤0.1%.
- Identification Method: Infrared spectroscopy (IR) — characteristic absorption peaks appear at 1650cm⁻¹, 1550cm⁻¹, 1200cm⁻¹; Thin layer chromatography (TLC) — clear spots, no miscellaneous spots; HPLC retention time is consistent with the standard product.
V. Storage, Transportation and Safety Specifications
1. Storage Requirements
- Packaging: Double-layer sealed packaging, inner layer is food-grade polyethylene plastic bag, outer layer is cardboard barrel or aluminum foil bag, which is tightly sealed to prevent moisture and air leakage.
- Storage Environment: Store in a cool, dry and well-ventilated place, avoid high temperature, humidity and strong light; control the relative humidity ≤60%, storage temperature ≤25℃.
- Shelf Life: Under sealed conditions, it can be stored stably for 12 months at room temperature; stored at 2-8℃, it can be stored stably for 24 months; it should be used as soon as possible after opening, and the remaining products should be re-sealed and stored in a refrigerated environment.
2. Transportation Requirements
- Transportation Method: Ordinary goods transportation, avoid high temperature, humidity and strong light during transportation, and properly fix the packaging to prevent damage and leakage.
- Loading and Unloading Requirements: Handle with care, avoid collision and extrusion, and prevent packaging damage and product moisture absorption or degradation.
3. Safety Protection
- Operation Protection: Operators should wear disposable gloves, protective masks and goggles to avoid direct skin contact and inhalation of dust; the operation area should be well-ventilated and equipped with flushing equipment.
- Emergency Treatment: If it comes into contact with the skin, rinse with plenty of water in time; if it gets into the eyes, rinse with plenty of water for 15 minutes, and seek medical advice if necessary; if accidentally ingested, drink plenty of warm water to induce vomiting and seek medical treatment in time.
VI. Application Fields and Specification Requirements
- Main Application Fields: ① Scientific research field — used as a research reagent for NAD+ metabolism, cell experiment and other related research; ② Fine chemical field — used as an intermediate for the synthesis of high-value derivatives; ③ Cosmetics field — used as a raw material for skin care products, playing a role in skin conditioning and protection; ④ Nutritional supplement field — used as a raw material for functional nutritional supplements (for research and development only, not for food addition without relevant qualifications).
- Specification Requirements: ① Industrial grade products are marked with "For Industrial Use Only"; ② Scientific research grade products are marked with "For Research Use Only"; ③ Cosmetic grade products must meet the relevant standards of cosmetic raw materials, and it is strictly prohibited to use them for clinical medical treatment, food addition and other fields without relevant qualifications; ④ When exported, it is necessary to provide a complete quality inspection report to meet the import standards of the target country/region.
