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Vitamin k2 (mk7 ) oil ( Specification , flow chart ,SDS ,Test report )

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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
0
0
0
98.7g



0
0
0
0
0
0
0
60
0
0
0
0
0.02
0.01
0
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 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.

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.

Page 1 of 2


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 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

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 2 of 2


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

1.

Appearance

2.
3.

Identification A
Identification B
Vitamin K2 (all-trans Menaquinone-7)

4.

Menaquinone-6

≤10%

HPLC

5.

Cis-Menaquinone-7


≤2.0%

HPLC

6.

Lead

≤3.0μg/g

EP/USP

7.

Arsenic

≤2.0μg/g

EP/USP

8.

Mercury

≤0.1μg/g

EP/USP

9.


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)
1.
2.
3.
4.
5.

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
0
98.7
0
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 1 of 8

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 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.








Compiled by:

Reviewed by:







Approved by :

华测检测认证集团北京有限公司
Centre Testing International Group

Beijing Co., Ltd.



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 2 of 8

A2210315158101001E
A2210315158101001E

检测结果:
Test Result(s):
序号

No.

1

2

3

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 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)

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)

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)


检 测 报 告
Test Report
报告编号:
Report No.:

第3页 共8页
Page 3 of 8

A2210315158101001E
A2210315158101001E

检测结果:
Test Result(s):
序号
No.

4

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 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

μg/g

2329


/

≥1500

符合
Accordance

6

酸价
Acid value
(Calculated in
fat)

mg(KOH)
/g

0.08

/

≤1.0

符合
Accordance

7

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 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)
GB 5009.229-2016
第二法
GB 5009.229-2016
Part 2
GB 5009.227-2016
第一法
GB 5009.227-2016
Part 1



检 测 报 告
Test Report
报告编号:
Report No.:

第4页 共8页
Page 4 of 8

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

8

总砷(以 As 计)
Total Arsenic

mg/kg

未检出
N.D.

0.010

≤0.1

符合
Accordance

9

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 1
GB 5009.12-2017
第一法
GB 5009.12-2017
Part 1

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 1

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 1
GB/T 5009.19-2008
第一法
GB/T 5009.19-2008
Part 1

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 1


检 测 报 告
Test Report
报告编号:
Report No.:

第5页 共8页
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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 1

/


GB 5009.22-2016
第一法
GB 5009.22-2016
Part 1

/

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)

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 1

15

菌落总数
Aerobic plate
count

CFU/g

<10

/

≤300

符合
Accordance

GB 4789.2-2016

16

霉菌和酵母
Moulds and
yeasts count


CFU/g

<10

/

≤25

符合
Accordance

17

大肠菌群
Coliform bacteria

MPN/g

<3.0

/

<3.0

符合
Accordance

GB 4789.15-2016
第一法
GB 4789.15-2016

Part 1
GB 4789.3-2016
第一法
GB 4789.3-2016
Part 1


检 测 报 告
Test Report
报告编号:
Report No.:

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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

18

大肠埃希氏菌
Escherichia coli

MPN/g

<3.0

/

<3.0

符合
Accordance

19

沙门氏菌

Salmonella

/25g

未检出
N.D.

/

不得检出
Absent

符合
Accordance

GB 4789.4-2016

20

金黄色葡萄球菌
Staphylococcus
aureus

符合
Accordance

GB 4789.10-2016
第一法
GB 4789.10-2016
Part 1


/25g

未检出
N.D.

/

不得检出
Absent

检测方法
Test Method
GB 4789.38-2012
第一法
GB 4789.38-2012
Part 1

以下空白
Blank below
备注:

Note(s):

1. DL = 检出限
2. N.D. =未检出
3. *1 表示该项目/方法不在 CNAS 认可范围内。
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.


检 测 报 告
Test Report
报告编号:
Report No.:

A2210315158101001E
A2210315158101001E

样品图片
Photo(s) of the sample(s)

第7页 共8页
Page 7 of 8


检 测 报 告
Test Report
报告编号:
Report No.:

A2210315158101001E
A2210315158101001E

第8页 共8页
Page 8 of 8

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 :

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:
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 ***




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