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
Trang 1FLOW 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
Dissolving
Packaging
Finished Products
Crystallization
Drying
Filtration
Trang 2Nutrition Statement
Product Name : Vitamin K2 Oil, 1.3% (in MCT oil)
Calories 909 kcal
Carbohydrates including sugar 0
Starch and Polyols 0
Dietary Fiber 0
Soluble fiber 0
Insoluble fiber 0
Fat 98.7g Saturated Fatty Acids —
Mono Unsaturated Fatty Acids —
Polyunsaturated Fatty Acids —
Cholesterol 0
Protein 0
Amino acids 0
Organic Acids 0
Vitamins (other) : 0
Vitamin A (ug RAE/100g) 0
Vitamin D (ug RAE/100g) 0
Vitamin E (mg/100g) 60
Folate (ug DFE/100g) 0
Niacin (mg NE/100g) 0
Potassium 0
Other Minerals 0
Moisture 0.02 Ash 0.01 Ethyl Alcohol 0
Assay (on dry base) 1.3
Date: 03.15,2022
Trang 3
Date: Mar 15, 2022
Allergen Statement
过敏原信息 Product Name: Vitamin K2 Oil, 1.3% (in MCT oil)
√ √
Items/项目 Contains
包含
Absent 不包含
Present on the same production line 出现在同一生产线
Present on the same production facility 出现在同一生产车间
Comments
备注
Nuts, including all tree nuts (ex Cashew, almond, pecan, √
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， √
Disaccharides (ex Sucrose, fructose)（二糖，如蔗糖、果 √
NMT7.5ppm
Trang 4Page 1 of 2
Safety Data Sheet (SDS)
VITAMIN K2 OIL, 1.3% (IN MCT OIL)
Revision date: 2022/01/04 Version: 1.2
Section 1: Product and Company Identification
Product Name Vitamin K2 Oil, 1.3% (In MCT Oil)
Chemical Formula C46H64O2
Company Information Inner Mongolia Kingdomway
Pharmaceutical Limited Tuoketuo Industrial Park, Hohhot, Inner Mongolia, China
Tel: 0086 471 8660088 Fax: 0086 471 8660099 Emergency telephone
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
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 do 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
Section 5: Fire-Fighting Measures 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 do 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
Trang 5Page 2 of 2
Section 9: Physical and Chemical Properties
9.1 Appearance Light yellow oily liquid
9.2 Odor Characteristic, no odor
9.3 Melting point/
Freezing point -8~18°C
9.4 Flash point 275°C
9.5 Density/ Relative
9.6 Molecular Weight 649.00g/mole
Section 10: Stability and Reactivity Data
Stability
The product is stable under the conditions mentioned in
chapter 7 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
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
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 15: Other Regulatory Information 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
Trang 6PRODUCT NAME Vitamin K2 Oil, 1.3%
Conform to USP standard Revision date: 2022/01/13 File No.: XKG-I-0016-04
1 Appearance Clear light yellow oil, odorless
Partial crystallisation may occur in low
temperature
Visual
2 Identification A
Identification B
Positive
10 Microbial Limit Test
Strain
↓ Fermentation
↓ Extraction
↓ Concentration
↓ Crystallization
↓ Drying
↓ Dissolving
↓ Filtration
↓ Packaging
↓ Finished Products
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)
PACKAGING
1kg Aluminum tin 5kg Aluminum tin 20kg Aluminum tin
Vitamin K2
(all-trans
Menaquinone-7)
NLT
Fermentation
Bacillus subtilis natto China
98.7%
Trang 7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
报告编号：A2210315158101001E Report No.:A2210315158101001E
Trang 8检 测 报 告
Test Report
华测检测认证集团北京有限公司
Centre Testing International Group
Beijing Co., Ltd
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
样品检测信息 Sample Testing information:
Inner Mongolia Kingdomway Pharmaceutical Limited
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:
Test Item(s):
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
检测结论：
Test Conclusion:
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 的公告 （2016 年第 8 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
Trang 9检 测 报 告
Test Report
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
检测方法 Test Method
light yellow /
浅黄色 light yellow
符合 Accordance
国家卫生和计划生育委 员会公告 2016 年第 8 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)
Taste, Odour*1 /
本品特有的气 味、滋味，无
异味 This product has unique smell and taste, without peculiar smell
/
本品特有的气 味、滋味，无
异味 This product has unique smell and taste, without peculiar smell
符合 Accordance
国家卫生和计划生育委 员会公告 2016 年第 8 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)
Clarification /
澄清或微混浊
油状 Clear or slightly turbid oily
符合 Accordance
国家卫生和计划生育委 员会公告 2016 年第 8 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)
Trang 10检 测 报 告
Test Report
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
检测方法 Test Method
无正常视力可 见的杂质
No foreign matter can be seen in normal vision
/
无正常视力可 见的杂质
No foreign matter can be seen in normal vision
符合 Accordance
国家卫生和计划生育委 员会公告 2016 年第 8 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)
5
维生素 K₂ 的
含量*1
vitamin K₂ *1
Accordance
国家卫生和计划生育委 员会公告 2016 年第 8 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)
6
酸价
Acid value
(Calculated in
fat)
mg(KOH)
Accordance
GB 5009.229-2016 第二法
GB 5009.229-2016 Part 2
Accordance
GB 5009.227-2016 第一法
GB 5009.227-2016 Part 1
Trang 11检 测 报 告
Test Report
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
检测方法 Test Method
Total Arsenic mg/kg
未检出
Accordance
GB 5009.11-2014 第一篇 第一法
GB 5009.11-2014 Chapter 1，Part 1
未检出
Accordance
GB 5009.12-2017 第一法
GB 5009.12-2017 Part 1
未检出
Accordance
GB 5009.17-2014 第一篇 第一法
GB 5009.17-2014 Chapter 1，Part 1
未检出
Accordance GB 5009.15-2014
未检出
Accordance
GB/T 5009.19-2008 第一法 GB/T 5009.19-2008 Part 1
未检出
Accordance
GB/T 5009.19-2008 第一法 GB/T 5009.19-2008 Part 1
14
黄曲霉毒素(B1+B2+G1+G2)
Total Aflatoxin(B1+B2+G1+G2)
黄曲霉毒素 B₁
Aflatoxin B₁ μg/kg
未检出
GB 5009.22-2016 第一法
GB 5009.22-2016 Part 1
Trang 12检 测 报 告
Test Report
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
检测方法 Test Method
黄曲霉毒素 B₂
Aflatoxin B₂ μg/kg
未检出
GB 5009.22-2016 第一法
GB 5009.22-2016 Part 1
黄曲霉毒素 G₁
Aflatoxin G₁ μg/kg
未检出
GB 5009.22-2016 第一法
GB 5009.22-2016 Part 1
黄曲霉毒素 G₂
Aflatoxin G₂ μg/kg
未检出
GB 5009.22-2016 第一法
GB 5009.22-2016 Part 1 黄曲霉毒素总量
(B₁ 、B₂ 、G₁ 、
G₂ )
Total Aflatoxin
(B1+B2+G1+G2)
Accordance
GB 5009.22-2016 第一法
GB 5009.22-2016 Part 1
15
菌落总数
Aerobic plate
count
Accordance GB 4789.2-2016
16
霉菌和酵母
Moulds and
yeasts count
Accordance
GB 4789.15-2016 第一法
GB 4789.15-2016 Part 1
符合 Accordance
GB 4789.3-2016 第一法
GB 4789.3-2016 Part 1
Trang 13检 测 报 告
Test Report
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
检测方法 Test Method
符合 Accordance
GB 4789.38-2012 第一法
GB 4789.38-2012 Part 1
未检出
不得检出 Absent
符合 Accordance GB 4789.4-2016
20
金黄色葡萄球菌
Staphylococcus
aureus
不得检出 Absent
符合 Accordance
GB 4789.10-2016 第一法
GB 4789.10-2016 Part 1 以下空白
Blank below
2 N.D =未检出
3 *1 表示该项目/方法不在 CNAS 认可范围内。
Note(s): 1 DL = Detection Limit
2 N.D =Not Detected
3 *1 indicates the item(s)/ the method(s) is (are) not in CNAS accreditation scope
Trang 14检 测 报 告
Test Report
样品图片 Photo(s) of the sample(s)
Trang 15检 测 报 告
Test Report
声明 Statement:
1 报告无批准人签字、检验检测专用章及报告骑缝章，或经涂改，以及复印报告未加盖红 色检验检测专用章均视作无效。
This report is considered invalidated in one or more of the following conditions: no approval signature; no testing seal of CTI; no cross-page seal; altered; a copy without the red testing seal of CTI
2 未经本公司批准，不得部分复制本报告。
Without written approval of CTI, this report shall not be reproduced partly
3 样品信息由客户提供，本报告检测结果仅对受检样品负责。
The sample Information is provided by the customer,and the results shown in this test report refer only to the sample(s) tested
4 不得擅自使用检测结果进行不当宣传。
Unauthorized use of the test results for improper publicity is impermissible
5 如果对检测结果有异议，请于收到报告之日起 15 日内提出，逾期不予受理。
Objection to the test results should be raised within 15 days from the date of receiving the report , otherwise it will not be accepted
6 扫 描 报 告 首 页 二 维 码 ， 即 可 查 询 报 告 真 伪 ， 如 有 疑 问 ， 请 联 系 邮 箱 ： fdd.checkreport@cti-cert.com。
Scan the QR code on the first page of the report, verify the authenticity of the report For any questions, please contact the following email: fdd.checkreport@cti-cert.com
7 本报告中的全部/部分检测项目未取得资质认定，仅供科研、教学、企业内部质量控制、 企业产品研发等目的用。
All/part of the test items in this report are not in the scope of qualification confirmation accreditation, and should be only used for scientific research, teaching, internal quality control and product development of enterprise
*** 报告结束 ***
*** End of report ***