FLOW CHART Vitamin K2 Oil, 1 0%1 3%2 0%5% Revision date 20200430 File No XKG I 3016 00 Strain Fermentation Extraction Concentration Dissolving Packaging Finished Products Crystallization Drying F. Section 1: Product and Company Identification Product Name Vitamin K2 Oil, 1.3% (In MCT Oil) CAS Number 2124574 Chemical Formula C46H64O2 1. Appearance Clear light yellow oil, odorless. Partial crystallisation may occur in low temperature Visual 2. Identification A Identification B Positive Corresponds to standard HPLC 3. Vitamin K2 (alltrans Menaquinone7) ≥ 1.3% HPLC 4. Menaquinone6 ≤10% HPLC
FLOW CHART Vitamin K2 Oil, 1.0%/1.3%/2.0%/5% Revision date: 2020/04/30 File No.: XKG-I-3016-00 Strain Fermentation Extraction Concentration Crystallization Drying Dissolving Filtration Packaging Finished Products Nutrition Statement Product Name: Vitamin K2 Oil, 1.3% (in MCT oil) Item Calories Carbohydrates including sugar Starch and Polyols Dietary Fiber Soluble fiber Insoluble fiber Fat Saturated Fatty Acids Mono Unsaturated Fatty Acids Polyunsaturated Fatty Acids Cholesterol Protein Amino acids Organic Acids Vitamins (other) : Vitamin A (ug RAE/100g) Vitamin D (ug RAE/100g) Vitamin E (mg/100g) Folate (ug DFE/100g) Niacin (mg NE/100g) Potassium Other Minerals Moisture Ash Ethyl Alcohol Assay (on dry base) Date: 03.15,2022 Content 909kcal 0 0 98.7g — — — 0 0 0 60 0 0 0.02 0.01 1.3 / 100 g Date: Mar 15, 2022 Allergen Statement 过敏原信息 Product Name: Vitamin K2 Oil, 1.3% (in MCT oil) √ √ Present on the same Items/项目 Contains Absent production line 包含 不包含 出现在同一生产线 Nuts, including all tree nuts (ex Cashew, almond, pecan, Peanuts （花生） Sesame seeds and derivatives （芝麻及其衍生品） Dairy （牛奶） Egg or egg derivatives （蛋类及其衍生品） Rice or rice derivatives（大米及其衍生品） Wheat or wheat derivatives（小麦及其衍生品） Soy or soy derivatives（大豆及其衍生品） Corn or corn derivatives（玉米及其衍生品） Gluten （麸质/面筋） Oat or oat derivatives （燕麦及其衍生品） Barley or barley derivatives（大麦/薏米及其衍生品） Fruit or fruit derivatives（水果类及其衍生品） Yeast or yeast derivatives（酵母类及其衍生品） Vegetable or vegetable derivatives（蔬菜类及其衍生品） Fish (ex Bass, flounder, cod or tuna) （鱼类，如鲈鱼、 Crustaceans including shellfish (ex Shrimp, lobster, or Mollusks (ex Snails, clams, octopus, or squid) Artificial flavorings, colors or preservatives（人工香料， Carmine/chocineal （胭脂红） Coal tar dyes（煤焦染料/食用色素） MSG（谷氨酸钠/味精） Benzoates (苯甲酸盐) Sulphites or metasulphites（亚硫酸盐，偏亚硫酸盐） BHA/BHT or related compounds（丁基羟基茴香醚/二丁 Artificial sweeteners（人工甜味剂） Monosaccharide (ex glucose)（单糖，如葡萄糖） Disaccharides (ex Sucrose, fructose)（二糖，如蔗糖、果 Polysaccharides (ex starch)（多糖，如淀粉） Sugar alcohols (which ones?)（糖醇类） Alcohol (which one?)（酒精） √ Present on the same production facility 出现在同一生产车间 Comments 备注 √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Ethanol NMT7.5ppm Mustard（芥茉） Celery（芹菜） Caffeine（咖啡因） Unrefined oils（未精炼的油类） Lupin（羽扇豆） Beef and beef derivatives （牛肉类及衍生品） Pork and pork derivatives（猪肉类及衍生品） Lamb and lamb derivatives（羔羊类及衍生品） Animal-derived gelatin （动物明胶） Other animal derivatives （其他动物来源的衍生品） √ √ √ √ √ √ √ √ √ √ Safety Data Sheet (SDS) Section 5: Fire-Fighting Measures VITAMIN K2 OIL, 1.3% (IN MCT OIL) Revision date: 2022/01/04 Version: 1.2 Section 1: Product and Company Identification Product Name CAS Number Chemical Formula Company Information Emergency telephone number Vitamin K2 Oil, 1.3% (In MCT Oil) 2124-57-4 C46H64O2 Inner Mongolia Kingdomway Pharmaceutical Limited Tuoketuo Industrial Park, Hohhot, Inner Mongolia, China Tel: 0086 471 8660088 Fax: 0086 471 8660099 0086 592 5200446 Section 2: Hazard Identification Classification of the substance The product is not classified hazardous according to the Regulation (EC) 1272/2008 and the Council Directives 67/548/EEC and 1999/45/EEC Eye contact May cause slight irritation Irrigate eye with water Seek medical attention if symptoms persist Skin contact Not skin irritant Section 3: Composition and Information on Ingredients Name Vitamin K2 MCT Oil Content 1.3% 98.7% CAS No 2124-57-4 65381-09-1 Section 4: First Aid Measures General advice Get medical advice Show this safety data sheet to the doctor in attendance Inhalation Remove victim to fresh air and keep at rest in a position comfortable for breathing If you feel that it is difficult to breath, please offer oxygen If not breathing, give artificial respiration Get medical advice Skin contact Remove/ Take off immediately all contaminated clothing Gently wash with plenty of soap and water If skin irritation or rash occurs: Get medical advice Eye contact Rinse cautiously with water for several minutes Remove contact lenses, if present and easy to Continue rinsing If eye irritation persists: Get medical Ingestion Never give anything by mouth to an unconscious person Rinse mouth with water Get medical advice Suitable extinguishing media Dry chemical, foam, carbon dioxide Unsuitable extinguishing media Water (It may scatter and spread fire.) Precautions for firefighters Fire-extinguishing work is done from the windward and the suitable fire-extinguishing evacuate to a safe place In case of fire in the surroundings: Remove movable containers if safe to so Special protective equipment for firefighters When extinguishing fire, be sure to wear personal protective equipment Section 6: Accidental Release Measures Environmental protection Do not allow to enter drains or waterways Nontoxic and biodegradable Methods for cleaning up Absorb spilled material in a suitable absorbent (e.g rag, dry sand, earth, saw-dust) In case of large amount of spillage, contain a spill by bunding Adhered or collected material should be promptly disposed of, in accordance with appropriate law and regulations Section 7: Handling and Storage Precautions for safe handling Technical measures: Handling is performed in a well -ventilated place Wear suitable protective equipment Prevent generation of vapour or mist Wash hands and face thoroughly after handling Use a ventilation, local exhaust if vapour or aerosol will be generated Advice on safe handling: Avoid contact with skin, eyes and clothing Storage The product shall be contained in the unopened original package, protected from light in a dry place at low temperature (≤20°C) Once it opened, please use it up in a short time Section 8: Exposure Controls / Personal Protection Personal protective equipment Respiratory protection not necessary during normal operations- in case of very high dust concentrations: particle mask or respirator with independent air supply Respiratory protection required when vapors/aerosols are generated Eye protection required (safety glasses) Hand protection protective gloves Remarks Strong skin discoloration on contact Page of Not a DOT controlled material (United States) Land and inland navigation transport (ADR/RID/GGVS/GGVE/ADNR) No hazardous material as defined by the transport regulations IATA Classification They are considered to be non-dangerous by the 63th IATA Dangerous Goods Regulations and it is not restricted as per SPECIAL PROVISION A3 Suggestion according to IMO IMDG Code The substance is not subject to IMO IMDG Code Section 9: Physical and Chemical Properties 9.1 Appearance 9.2 Odor 9.3 Melting point/ Freezing point 9.4 Flash point 9.5 Density/ Relative density 9.6 Molecular Weight Light yellow oily liquid Characteristic, no odor -8~18°C 275°C 0.915~0.938g/mL 649.00g/mole Section 10: Stability and Reactivity Data Section 15: Other Regulatory Information Stability The product is stable under the conditions mentioned in chapter The product is stable When exposed to light and heat, potency will deteriorate Conditions to avoid Sensitive to air, sensitive to light Should preserve in inert gases Materials to avoid Strong oxidizing agents Hazardous polymerization Not determined nor anticipated under normal handling & storage conditions Section 11: Toxicological Information Routes of entry Eye contact Inhalation Effects of overexposure No signs and symptoms of exposure Chronic effect No signs and symptoms of exposure Other toxic effects on humans May irritate to eyes Medical conditions generally aggravated by exposure No information available EINECS This product is on the European Inventory of Existing Commercial Chemical Substances Protective equipment Gloves, lab coat, dust respirator, be sure to use an approved/certified respirator or equivalent, safety glasses Section 16: Other Information References Not available Other Special Considerations Not available The information above is believed to be accurate and represents the best information currently available to us However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use Users should make their own investigations to determine the suitability of the information for their particular purposes Section 12: Ecological Information Bioaccumulation No information available Biodegradability Inherently biodegradable Toxicity No information available Section 13: Disposal Considerations Dispose of in accordance with all applicable local, regional and national environmental laws and regulations Incineration of waste material is a permitted facility in accordance with local, regional and federal regulations is recommended Section 14: Transport Information DOT classification Page of Vitamin K2 Oil, 1.3% (in MCT oil) Conform to USP standard PRODUCT NAME PHARMACOPOEIA NAME Menaquinone-7 Revision date: 2022/01/13 ITEM File No.: XKG-I-0016-04 SPECIFICATION TEST METHOD Clear light yellow oil, odorless Partial crystallisation may occur in low temperature Positive Corresponds to standard ≥ 1.3% Visual Appearance Identification A Identification B Vitamin K2 (all-trans Menaquinone-7) Menaquinone-6 ≤10% HPLC Cis-Menaquinone-7 ≤2.0% HPLC Lead ≤3.0μg/g EP/USP Arsenic ≤2.0μg/g EP/USP Mercury ≤0.1μg/g EP/USP Cadmium ≤1.0μg/g EP/USP ≤1000cfu/g ≤100cfu/g Negative/g Negative/10g Negative/g EP/USP EP/USP EP/USP EP/USP EP/USP HPLC HPLC 10 Microbial Limit Test (1) Total Plate Count (2) Yeast & Mold (4) E Coli (5) Salmonella (6) S.aureus MANUFACTURING PROCESS SHELF LIFE (UNOPENED) 24 months STORAGE The product shall be contained in the unopened original package, protected from light in a dry place at low temperature (≤20°C) Once it opened, please use it up in a short time NUTRITIONAL INFORMATION (PER 100G OF RAW MATERIAL) ITEM Energy Protein Total Fat Carbohydrates Sodium UNIT KJ g g g mg PACKAGING ITEM ASSAY Vitamin K2 (all-trans Menaquinone-7) NLT 1.3% MCT Oil NMT 98.7% VALUE 3803 98.7 0 1kg Aluminum tin 5kg Aluminum tin 20kg Aluminum tin OBTAINING ROUTE STRAIN ORIGIN Microbial Fermentation Bacillus subtilis natto China Strain ↓ Fermentation ↓ Extraction ↓ Concentration ↓ Crystallization ↓ Drying ↓ Dissolving ↓ Filtration ↓ Packaging ↓ Finished Products 报告编号：A2210315158101001E Report No.:A2210315158101001E 检测报告 Test Report 样品名称: 维生素 K2（发酵法）油剂 Sample Name : Vitamin K2 Oil 委托单位: 内蒙古金达威药业有限公司 Client Name: Inner Mongolia Kingdomway Pharmaceutical Limited 检测类型: 委托检测 Type: Authorized test 华测检测认证集团北京有限公司 Centre Testing International Group Beijing Co., Ltd www.cti-cert.com 检 测 报 告 Test Report 报告编号： Report No.: 第1页 共8页 Page of A2210315158101001E A2210315158101001E 委托单位： 内蒙古金达威药业有限公司 Client Name: Inner Mongolia Kingdomway Pharmaceutical Limited 委托单位地址： 内蒙古自治区呼和浩特市托克托工业园区 Tuoketuo Industrial Park, Hohhot, Inner Mongolia, 010206 China Client Address : 样品检测信息 Sample Testing information: 样品名称 Sample Name ： 维生素 K2（发酵法）油剂 / Vitamin K2 Oil 样品状态 Sample Status ： 油状 / Oily 样品商标 Sample Brand ：/ 生产日期 Product Date ： 2021.06.03 样品数量 Sample Quantity ： 600mL 批号 Lot No ： 81-210602 规格 Specification ：/ 生产厂家 Manufacturer ： 内蒙古金达威药业有限公司 / Inner Mongolia Kingdomway Pharmaceutical Limited 生产厂家地址 Address of Manufacturer ： 内蒙古自治区呼和浩特市托克托工业园区 / Tuoketuo Industrial Park, Hohhot, Inner Mongolia, 010206 China 样品接收日期 Sample Received Date ： 2021/08/06 样品检测日期 Sample Tested Date ： 2021/08/06～2021/08/16 检测项目: 色泽，滋味、气味，性状，杂质，维生素 K₂ 的含量等 20 项 Color, Taste, Odour, Character ,Impurity, vitamin K₂ etc 20 items Test Item(s): 检测结论： 经检测，所检项目符合国家卫生计生委 关于海藻酸钙等食品添加剂新品种 Test Conclusion: 的公告 （2016 年第 号）要求。 The following tested items of samples meet the requirements specified in Announcement of the national health and Family Planning Commission on new varieties of food additives such as calcium alginate (No 8, 2016) 详细信息请见下页。 See next page for detail 编 制 审 核 Compiled by: Reviewed by: 批 日 准 Approved by : 华测检测认证集团北京有限公司 Centre Testing International Group Beijing Co., Ltd 期 Approved date: 2021 年 08 月 20 日 检测地址：北京市北京经济技术开发区科创十四街 99 号 20 幢 Testing address: Bldg No.20,No.99 Kechuang Fourteen Street,Beijing Economic Development Zone, Beijing 公司地址：北京市北京经济技术开发区科创十四街 99 号 21 幢 Company address: Bldg No.21,No.99 Kechuang Fourteen Street,Beijing Economic Development Zone, Beijing 检 测 报 告 Test Report 报告编号： Report No.: 第2页 共8页 Page of A2210315158101001E A2210315158101001E 检测结果： Test Result(s): 序号 No 检测项目 Test Item(s) 色泽*1 Color*1 滋味、气味*1 Taste, Odour*1 性状*1 Character*1 单位 Unit / / / 检测结果 Test Result 浅黄色 light yellow 本品特有的气 味、滋味，无 异味 This product has unique smell and taste, without peculiar smell 澄清 Clarification 检出限 DL / / / 标准要求 Limit 浅黄色 light yellow 本品特有的气 味、滋味，无 异味 This product has unique smell and taste, without peculiar smell 澄清或微混浊 油状 Clear or slightly turbid oily 单项结论 Conclusion 检测方法 Test Method 符合 Accordance 国家卫生和计划生育委 员会公告 2016 年第 号 三、维生素 K₂ (发酵法) Announcement No 8, 2016 of the national health and Family Planning Commission 3、Vitamin K2 (fermentation method) 符合 Accordance 国家卫生和计划生育委 员会公告 2016 年第 号 三、维生素 K₂ (发酵法) Announcement No 8, 2016 of the national health and Family Planning Commission 3、Vitamin K2 (fermentation method) 符合 Accordance 国家卫生和计划生育委 员会公告 2016 年第 号 三、维生素 K₂ (发酵法) Announcement No 8, 2016 of the national health and Family Planning Commission 3、Vitamin K2 (fermentation method) 检 测 报 告 Test Report 报告编号： Report No.: 第3页 共8页 Page of A2210315158101001E A2210315158101001E 检测结果： Test Result(s): 序号 No 检测项目 Test Item(s) 杂质*1 Impurity*1 单位 Unit / 检测结果 Test Result 无正常视力可 见的杂质 No foreign matter can be seen in normal vision 检出限 DL / 标准要求 Limit 无正常视力可 见的杂质 No foreign matter can be seen in normal vision 单项结论 Conclusion 检测方法 Test Method 符合 Accordance 国家卫生和计划生育委 员会公告 2016 年第 号 三、维生素 K₂ (发酵法) Announcement No 8, 2016 of the national health and Family Planning Commission 3、Vitamin K2 (fermentation method) 维生素 K₂ 的 含量*1 vitamin K₂ *1 μg/g 2329 / ≥1500 符合 Accordance 酸价 Acid value (Calculated in fat) mg(KOH) /g 0.08 / ≤1.0 符合 Accordance 过氧化值 Peroxide value meq/kg 1.2 / ≤5.0 符合 Accordance 国家卫生和计划生育委 员会公告 2016 年第 号 三、维生素 K₂ (发酵法) Announcement No 8, 2016 of the national health and Family Planning Commission 3、Vitamin K2 (fermentation method) GB 5009.229-2016 第二法 GB 5009.229-2016 Part GB 5009.227-2016 第一法 GB 5009.227-2016 Part 检 测 报 告 Test Report 报告编号： Report No.: 第4页 共8页 Page of A2210315158101001E A2210315158101001E 检测结果： Test Result(s): 序号 No 检测项目 Test Item(s) 单位 Unit 检测结果 Test Result 检出限 DL 标准要求 Limit 单项结论 Conclusion 总砷(以 As 计) Total Arsenic mg/kg 未检出 N.D 0.010 ≤0.1 符合 Accordance 铅(Pb) Lead mg/kg 未检出 N.D 0.04 ≤0.1 符合 Accordance 检测方法 Test Method GB 5009.11-2014 第一篇 第一法 GB 5009.11-2014 Chapter 1，Part GB 5009.12-2017 第一法 GB 5009.12-2017 Part 10 汞(Hg) Mercury mg/kg 未检出 N.D 0.01 ≤0.05 符合 Accordance GB 5009.17-2014 第一篇 第一法 GB 5009.17-2014 Chapter 1，Part 11 镉(Cd) Cadmium mg/kg 未检出 N.D 0.003 ≤0.1 符合 Accordance GB 5009.15-2014 12 六六六 HCH mg/kg 未检出 N.D 0.01 ≤0.05 符合 Accordance 13 滴滴涕 DDT mg/kg 未检出 N.D 0.01 ≤0.05 符合 Accordance GB/T 5009.19-2008 第一法 GB/T 5009.19-2008 Part GB/T 5009.19-2008 第一法 GB/T 5009.19-2008 Part 黄曲霉毒素(B1+B2+G1+G2) Total Aflatoxin(B1+B2+G1+G2) 14 黄曲霉毒素 B₁ Aflatoxin B₁ μg/kg 未检出 N.D 0.1 / / GB 5009.22-2016 第一法 GB 5009.22-2016 Part 检 测 报 告 Test Report 报告编号： Report No.: 第5页 共8页 Page of A2210315158101001E A2210315158101001E 检测结果： Test Result(s): 序号 No 检测项目 Test Item(s) 单位 Unit 检测结果 Test Result 检出限 DL 标准要求 Limit 单项结论 Conclusion 黄曲霉毒素 B₂ Aflatoxin B₂ μg/kg 未检出 N.D 0.1 / / 黄曲霉毒素 G₁ Aflatoxin G₁ 黄曲霉毒素 G₂ Aflatoxin G₂ μg/kg μg/kg 未检出 N.D 未检出 N.D 0.1 0.1 / / 检测方法 Test Method GB 5009.22-2016 第一法 GB 5009.22-2016 Part / GB 5009.22-2016 第一法 GB 5009.22-2016 Part / GB 5009.22-2016 第一法 GB 5009.22-2016 Part 黄曲霉毒素总量 (B₁ 、B₂ 、G₁ 、 G₂ ) Total Aflatoxin (B1+B2+G1+G2) μg/kg 未检出 N.D 0.1 ≤5.0 符合 Accordance GB 5009.22-2016 第一法 GB 5009.22-2016 Part 15 菌落总数 Aerobic plate count CFU/g