GB 1903.81-2025 English PDF

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GB 1903.81-2025: National food safety standard - Nutrition fortifier - Vitamin K2 (Synthesis method)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 1903.81-2025	179	Add to Cart	3 days	National food safety standard - Nutrition fortifier - Vitamin K2 (Synthesis method)	Valid

Basic data

Standard ID: GB 1903.81-2025 (GB1903.81-2025)
Description (Translated English): National food safety standard - Nutrition fortifier - Vitamin K2 (Synthesis method)
Sector / Industry: National Standard
Classification of Chinese Standard: X40
Word Count Estimation: 9,970
Date of Issue: 2025-09-02
Issuing agency(ies): National Health Commission; State Administration for Market Regulation

GB 1903.81-2025: National food safety standard - Nutrition fortifier - Vitamin K2 (Synthesis method)

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB1903.81-2025
National Standards of the People's Republic of China National Food Safety Standards Vitamin K2 (synthetic method), a food fortifier Published on 2025-09-02 Implemented on 2026-03-02 National Health Commission of the People's Republic of China State Administration for Market Regulation issued National Food Safety Standards Vitamin K2 (synthetic method), a food fortifier 1.Scope This standard applies to products made from vitamin K3 and heptaenolide, or products made from vitamin K3, farnesol, and geraniol, through chemical synthesis. Vitamin K2 is a food fortifier produced by process. 2.Chemical name, molecular formula, structural formula, and relative molecular mass 2.1 Chemical Name 2.2 Molecular Formula C46H64O2 2.3 Structural Formula 2.4 Relative Molecular Mass 649.02 (based on 2022 international relative atomic mass)

3 Technical Requirements

3.1 Sensory Requirements Sensory requirements shall comply with the provisions of Table 1. Table 1 Sensory Requirements Project Requirements Inspection Methods Color. beige to yellow State of powder Odorless Place an appropriate amount of sample in a clean, dry white porcelain dish and observe it under natural light. Its color, state, and smell 3.2 Physicochemical Indicators The physicochemical properties should meet the requirements of Table 2. Table 2 Physicochemical Indicators Project indicator testing methods Vitamin K2 content, w/% 98.0~102.0 (see Appendix A, A.4) Relative content of vitamin K2 cis isomer, relative area/% ≤ 2.0 (See Appendix A, A.5) Moisture,w/% ≤ 0.5 GB 5009.3 Ash content, w/% ≤ 0.1 GB 5009.4 Lead (Pb)/(mg/kg) ≤ 2.0 GB 5009.12 or GB 5009.75 Total arsenic (as As)/(mg/kg) ≤ 1.0 GB 5009.11 or GB 5009.76 Cadmium (Cd)/(mg/kg) ≤ 0.5 GB 5009.15 Total mercury (as Hg)/(mg/kg) ≤ 0.1 GB 5009.17 Note. Commercially available vitamin K2 (synthetic method) products should use vitamin K2 (synthetic method) that conforms to this standard as raw material, and add food ingredients required for the process. When prepared using food additives as excipients, their quality, scope, and dosage shall comply with the relevant national food safety standards, and their content indicators shall comply with... claim. 3.3 Microbiological Indicators Microbiological indicators should comply with the requirements in Table 3. Table 3 Microbiological Indicators Project Limit Testing Methods Total bacterial count (CFU/g) ≤ 1000 GB 4789.2 Mold and yeast count (CFU/g) ≤ 50 GB 4789.15 Coliform bacteria/(MPN/g) ≤ 0.92 GB 4789.3 Salmonella/25g should not be detected (GB 4789.4) Staphylococcus aureus/25g should not be detected (GB 4789.10)

Appendix A

Test methods A.1 Safety Tips Some reagents used in the test methods of this standard are toxic or corrosive, and should be used with caution and in accordance with relevant regulations. If splashed on the skin, rinse immediately with water; severe cases require immediate medical attention. Volatile acids should be used in a fume hood. A.2 General Provisions Unless otherwise specified, only reagents certified as analytical grade and Grade I water as specified in GB/T 6682 shall be used in the analysis. (The test methods are not specified in the provided text.) Unless otherwise specified, standard titration solutions, standard solutions for impurity determination, preparations and products shall be handled in accordance with GB/T 601. Prepared according to the specifications in GB/T 602 and GB/T 603.Unless otherwise specified, all solutions used are aqueous solutions. Vitamin K2 is sensitive to light, so care should be taken to avoid light during the experiment. A.3 Identification Test High-performance liquid chromatography (HPLC) analysis was performed according to the method for determining vitamin K2 content. The retention times of the sample and vitamin K2 standard were compared. The retention time of the main peak in the chromatogram of the sample should be consistent with that of the main peak in the standard. A.4 Determination of Vitamin K2 Content A.4.1 Method Principles The sample was dissolved in tetrahydrofuran and analyzed by high-performance liquid chromatography under specified conditions. The retention time was compared with that of vitamin K2 standard. The content of vitamin K2 in the sample was determined by external standard method based on peak area. A.4.2 Reagents and Materials A.4.2.1 Tetrahydrofuran. chromatographically pure. A.4.2.2 Anhydrous ethanol. chromatographic grade. A.4.2.3 Vitamin K2 standard. heptaenide-7 (MK-7, molecular formula. C46H64O2, CAS No.. 2124-57-4), purity ≥98%, or as determined by [further testing/treatment]. Nationally certified reference materials that have been granted reference material certificates. A.4.2.4 Vitamin K2 Standard Stock Solution. Weigh 25 mg (accurate to 0.1 mg) of vitamin K2 standard (A.4.2.3) into 50 mL In a brown volumetric flask, add 1 mL of tetrahydrofuran (A.4.2.1), dissolve, and then dilute to the mark with anhydrous ethanol (A.4.2.2). Mix well and filter. The membrane, as a stock solution, should be stored at 0℃~4℃ away from light, with a shelf life of 1 month. A.4.2.5 Vitamin K2 Standard Solution. Pipette 5 mL of vitamin K2 standard stock solution (A.4.2.4) into a 25 mL brown volumetric flask. In the middle, dilute to the mark with anhydrous ethanol (A.4.2.2), mix well, filter through a membrane, and prepare fresh for use. A.4.2.6 Sample solution. Weigh 25 mg (accurate to 0.1 mg) of the sample into a 50 mL brown volumetric flask, add 1 mL of tetrahydrofuran. (A.4.2.1), dissolve and dilute to the mark with anhydrous ethanol (A.4.2.2). Pipette 5 mL of this solution into a 25 mL amber volumetric flask, and dilute with anhydrous ethanol. Add water and ethanol (A.4.2.2) to the mark, mix well, and filter through a membrane. A.4.2.7 Microporous filter membrane. 0.45μm, organic system. A.4.3 Instruments and Equipment A.4.3.1 High-performance liquid chromatograph. equipped with an ultraviolet detector or a diode array detector. A.4.3.2 Analytical balance. sensitivity 0.1 mg. A.4.4 Reference chromatographic conditions A.4.4.1 Chromatographic column. C18 column, 4.6 mm × 25 cm, particle size 2.6 μm, or equivalent column. A.4.4.2 Mobile phase. anhydrous ethanol. water = 97.3. A.4.4.3 Flow rate. 0.7 mL/min. A.4.4.4 Column temperature. 25℃. A.4.4.5 Injection volume. 10 μL. A.4.4.6 Detection wavelength. 268nm. A.4.4.7 Detection time. at least 1.5 times the retention time of the vitamin K2 peak. A.4.5 Analysis Steps A.4.5.1 System Adaptability Inject a vitamin K2 standard solution (A.4.2.5) into the liquid chromatograph, record the chromatogram, and repeat the injection 6 times. Observe the peak area of vitamin K2. The relative standard deviation (RSD) of the response value should not exceed 3.0%, and the resolution R between the vitamin K2 main peak and its nearest impurity peak should not be less than [value missing]. 1.5. A.4.5.2 Sample Determination After the system's adaptability was deemed satisfactory, 10 μL of both the standard solution (A.4.2.5) and the sample solution (A.4.2.6) were injected into the liquid chromatograph for testing. The determination was performed using retention time for qualitative analysis and peak area as the external standard method for quantitative analysis. See Figure B.1 in Appendix B for a reference chromatogram. A.4.6 Result Calculation Vitamin K2 content W1, expressed as w/%, is calculated using formula (A.1). W1= Au As× Cs Cu× 100 (A.1) In the formula. Au --- Peak area corresponding to vitamin K2 in the sample; As --- Peak area corresponding to vitamin K2 in the standard; Cs --- The mass concentration of vitamin K2 in the standard solution, expressed in milligrams per milliliter (mg/mL); Cu --- The mass concentration of vitamin K2 in the sample solution, expressed in milligrams per milliliter (mg/mL); 100 --- Conversion factor. The experimental results are considered the arithmetic mean of parallel measurements. The absolute difference between two independent measurements obtained under repeatability conditions is also considered. The value is no greater than 10% of the arithmetic mean. A.5 Determination of the relative content of vitamin K2 cis isomer A.5.1 Method Principles The sample was dissolved in tetrahydrofuran and ethanol, separated by high-performance liquid chromatography (HPLC), and detected by a UV detector. Qualitative analysis was performed based on relative retention time. The percentage of the cis peak area to the sum of the cis and trans peak areas is used to determine the relative content of the cis isomer of vitamin K2 in the sample. A.5.2 Reagents and Solutions A.5.2.1 Anhydrous ethanol. chromatographic grade. A.5.2.2 Methanol. chromatographic grade. A.5.2.3 Tetrahydrofuran. chromatographically pure. ......

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