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Pharmaquinone® 99% Active Ingredient Vitamin K2 as MK-7
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Pharmaquinone® 99% Active Ingredient Vitamin K2 as MK-7

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Product Overview
Essential details
Product name
Pharmaquinone® 99% Active Ingredient Vitamin K2 as MK-7
SKU code
K2MK7
Chemical names
Menaquinone-7 (MK-7)
Common name
Vitamin K2
General product information
Synthetic Vitamin K2 as MK-7 for use in food and dietary supplements
Country of origin
Poland
Manufacturer
Vitasynth
Sample
Available
Our certificates
Industry standard
Industry standard
Industry standard
Industry standard
Industry standard
Industry standard
Delivery
Packaging & labelling
HDPE bottles (high   density   polyethylene)   intended   for contact with food, protecting light-sensitive contents
Storage conditions
The packaged product should be stored at 5-25°C / 41-77°Fand 20-70% humidity. Protect from light and excessive heat. The product is very light sensitive and exposure may deteriorate K2 activity considerably. Avoid excessive humidity.
Batch/lot numbering system
API2307-1
API - the product SKU code
yy.mm - the date format
1st batch of the month
Label information
Product name and SKU code
Batch no., manufacturing date & best before
Handling precautions
VitaSynth contact information
Icons identifying certifications such as Kosher or Halal status
Recommended restriction / Market specific labelling is implemented where required limitation on finished product label
Market specific labelling is implemented where required. Vitamin K2 may counteract the effects of anticoagulation therapy, and therefore is not recommended for patients on blood-thinning medications. The maximal daily dose in food supplement of 0.2 mg should not be exceeded
Up to 300kg
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Above 301kg
db schenker
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Download separate files:
1. Product Information Data Sheet

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2. Packaging specification

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packaging specification
packaging specification
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packaging specification
3. Product specification

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4. Analytical instructions

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5. Dilution preparation instructions

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6. Catalogue

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PQ catalogue page
PQ catalogue page
PQ catalogue page
Sample Certificate of Analysis
Tests
Requirements
Results
Description: Visual determination
Yellow crystalline powder
Complies
Identification
IR spectrum (KBr)
HPLC
Corresponds to the standard IR spectrum
Corresponds to the standard HPLC profile
Complies
Assay of vitamin K2 (MK7) (UPLC method*
Not less than 99.0% - not more than 101.0%
100.65 %
Related substances (UPLC method*) Total impurities
Not more than 1.00%
< 0.03 %
Assay of vitamin K2 (MK7) (USP method)
Not less than 99.0% - not more than 101.0%
100.26 %
Isomeric purity (USP method) Content of cis-menaquinone-7
Not more than 1.00%
Not detected
Loss on drying
Not more than 0.50%
0.19 %
Sulphated ash
Not more than 0.10%
0.02 %
Residual solvents'

Ethanol

Ethyl acetate


Not more than 1500 ppm

Not more than 500 ppm


Not detected

< 30 ppm
Heavy metals

Arsenic

Cadmium

Lead

Mercury


Not more than 2 ppm

Not more than 1 ppm

Not more than 3 ppm

Not more than 0.1 ppm


< 0.33 ppm

< 0.33 ppm

< 0.41 ppm

< 0.10 ppm
Product Information Data Sheet
Pharmaquinone logo

Pharmaquinone® 99% Active Ingredient Vitamin K2 as MK-7

1. Product Identity and Form
Product name
Pharmaquinone® 99% Active Ingredient Vitamin K2 as MK-7
SKU code
K2MK7
CAS number
2124-57-4
Chemical names
Menaquinone-7 (MK-7)
Common name
Vitamin K2
General product information
Synthetic Vitamin K2 as MK-7 for use in food and dietary supplements
Country of origin
Poland
2. Responsible for Product Development, Research and Regulatory Affairs
Product developer, marketing responsible IPR holder and regulatory affairs
VitaSynth Sp. z o. o.
Office and postal address
2 Szałwiowa Street 03-167 Warsaw Poland
Telephone
+48 22 602 22 29
Info
sales@pharmaquinone.com
Web
www.pharmaquinone.com
Country of origin
Poland
3. Manufacturing and Quality Assurance/Quality Control Information
QA/QC and control Manufacturer
VitaSynth
Manufacturing process
Multi-stage organic synthesis of vitamin MK7 frommenadione, geraniol and farnesol
Manufacturing flow chart
See section 14
Quality Assurance Systems
See section 5 for details.
Certificates available upon request
Residual solvent in accordance
See section 6 for details
Irradiation or chemical sterilization
No irradiation or chemical sterilization is used during production. See section 6 Regulatory Status
Traceability system for product identity
In place
SDS
See section 15
Last revision of QA/QC systems
2023
4. Lot Number System, Product Storage, Packaging and Labelling Information
Packaging and labelling
HDPE bottles (high   density   polyethylene)   intended   for contact with food, protecting light-sensitive contents
Storage conditions
The packaged product should be stored at 5-25°C / 41-77°F and 20-70% humidity. Protect from light and excessive heat. The product is very light sensitive and exposure may deteriorate K2 activity considerably. Avoid excessive humidity.
Batch/lot numbering system
API2307-1
API - the product SKU code
yy.mm - the date format
1st batch of the month
Label information
Product name and SKU code
Batch no., manufacturing date & best before
Handling precautions
VitaSynth contact information
Icons identifying certifications such as Kosher or Halal status
Recommended restriction / limitation on finished product label
Market specific labelling is implemented where required. Vitamin K2 may counteract the effects of anticoagulation therapy, and therefore is not recommended for patients on blood-thinning medications. The maximal daily dose in food supplement of 0.2 mg should not be exceeded
5. Certifications and Compliance
Certification
Status
Third party
Expiry
Kosher
Certified
EarthKosher
18.08.2023
Halal
Certified
HFCE
31.01.2024
Vegan
Certified
Vegan Society
20.06.2024
FDA
Statement*
NA
NA
cGMP
Statement*
NA
NA
HACCP
Certified
NA
NA
ISO (FSSC22000)
Certified
NA
NA
Non-GMO
Statement*
NA
NA
* See section 16
6. Regulatory Status and IPR

Compliance with Regulations
Pharmaquinone® Products are identical to already authorised under Regulation 258/1997/EC novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation EU 20015/2283. Therefore Pharmaquinone® Products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® Productsare in line with the authorised specifications and conditions of use as set out in the Union list of authorised novel foods and/or the implementing Regulations authorizing these substances in accordance to COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.

Compliance to Regulations in Europe and the US
GMO
Complies with EU Regulation No 1829/2003, including amended EU Directive 2001/18/EC
Ionizing radiation
Complies with EU Directive 1999/2/EC.Product has not been sterilized
Contaminants/toxins
Complies with Regulation (EC) No. 1881/2006 setting maximum levels for certain contaminants in food stuffs and amendments as per(EC) No 629/2008 of 2 July 2008
Pesticides
Complies with EU Regulations (EC) No 396/2005, including amended EU Directive 91/414/EEC
Residual Solvents
Complies with good manufacturing practice, EU Directive 2009/32/EC and Ph. Eur. p. 2.4.24 / USP <467> Residual Solvents requirements
BSE/TSE*
Complies with good manufacturing practice and EU Regulation (EC)No 999/2001.
Prop 65
Does not contain compounds listed in California Proposition 65
Nano material
No nano material substances as per definition of EU REG.1169/2011
WADA
Do not contain any substances included in the prohibited list of the World Anti-Doping Agency (WADA)
* See section 16
Stability Protocol

Stability program follows ICH Guideline to meet market specific requirements.

Product name: Pharmaquinone®99%Active Ingredient, Vitamin K2 as MK-7
Batch No.: MK7-20.05.08
Mfg. date: 05.2020
Exp. date: 06.2022
Study:  Accelerated Time period: 6months
Storage   condition: 40°C  ±  2°C/ 75% RH ± 5% RH
Time period covered by data at submission: 6months
TESTS
REQUIREMENTS
METHOD
Result (0M)
Result(3M)
Result(6M)
1. Description
Yellow crystalline powder
Visual assessment
Comply
Comply
Comply
2.Assay of vitamin K2 (MK7)
Not less than 99.0% -not more than 101.0 %
UPLC method (Jedynak et al.)
100,75%
100,40%
100,81%
3. Assay of vitaminK2 (MK7)
Not less than 99.0% -not more than 101.0 %
USP method
100,49%
100,78%
100,78%
4. Related substances Total impurities
Not more than 1.00%
UPLC method (Jedynak et al.)
0,21%
0,19%
0,21%
5. Isomeric purity Content of cismenaquinone-7
Not more than 1.00%
USP method
ND
ND
ND
6. Loss on drying
Not more than 0.50 %
Ph. Eur.<2.2.32>
0,09%
0,14%
0.00%
Study:  Accelerated Time period: 36 months
Storage   condition: 25°C  ±  2°C/ 60% RH ± 5% RH
Time period covered by data at submission: 24 months
TESTS
REQUIREMENTS
METHOD
Result (0M)
Result(6M)
Result(9M)
Result(12M)
Result(18M)
Result(24M)
1. Description
Yellow crystalline powder
Visual assessment
Comply
Comply
Comply
Comply
Comply
Comply
2.Assay of vitamin K2 (MK7)
Not less than 99.0% -not more than 101.0 %
UPLC method (Jedynak et al.)
100,75%
100,65%
100,33%
100,61%
100.25 %
99.96 %
3. Assay of vitaminK2 (MK7)
Not less than 99.0% -not more than 101.0 %
USP method
100,49%
100,72%
100,46%
100,34%
100.37 %
99.65 %
4. Related substances Total impurities
Not more than 1.00%
UPLC method (Jedynak et al.)
0,21%
0,19%
0,22%
0,21%
0.22 %
0.28 %
5. Isomeric purity Content of cismenaquinone-7
No more than 1.00%
USP method
ND
ND
ND
ND
ND
ND
6. Loss on drying
Not more than 0.50 %
Ph. Eur. 2.2.32
0,09%
0.00%
0.00%
0.05%
0.12 %
0,29 %
Intellectual Property Rights/Patents Granted/Patent Pending

To whom it may concern,

To the best of our knowledge, the Product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

Tariff Code, FDA Registration and Compendial Standard
EU export tariff code
2936 29 00 00
US import tariff code
2936 29 50 50
U.S. FDA Registration VitaSynth No.
18752137180
DUNS VitaSynth No.
425446420
Compendial standard
USP monograph for menaquinone-7 and in-house methods
7. Food Safety System

To whom it may concern,

Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU.The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

8. Origin and Composition
Name ingredient
Origin
CAS
Concentration
Manufacturer
GMO status
Menaquinone-7
Chemical synthesis
2124-57-4
NLT 99%
Vitasynth
non-GMO
9. Nutritional Profile*
Component
Typical value per 100 g
Total calories
NA
Total proteins
NA
Total fat
NA
Dietary fiber
NA
Total sugars
NA
Carbohydrates
NA
Salt
NA
Vitamin K2 as MK7
NLD 99%
* Based on theoretical calculations
10. Allergens on Production Line

Free from allergens in compliance with EU Directive 1169/2011 Annex II

Raw material/allergen
Presence in Pharmaquinone® Product
Presence on production line for other products
Cereals containing gluten1 and products thereof
No
No
Crustaceans and products thereof
No
No
Eggs and products thereof
No
No
Fish and products thereof
No
No
Peanuts and products thereof
No
No
Soybeans and products thereof
No
No
Milk and products thereof (including lactose)
No
No
Nuts2 and products thereof
No
No
Celery and products thereof
No
No
Mustard and products thereof
No
No
Sesame seeds and products thereof
No
No
Sulphur dioxide and sulphites3
No
No
Lupin and products thereof
No
No
Molluscs and products thereof
No
No
11. Free from Allergen Statement

To whom it may concern,

In compliance with EU Directive 1169/2011 Annex II
1. Cereals containing gluten
2. Crustaceans and products thereof
3. Eggs and products thereof
4. Fish and products thereof
5. Peanuts and products thereof
6. Soybeans and products thereof
7. Milk and products thereof (including lactose)
8. Nuts and products thereof
9. Celery and products thereof
10. Mustard and products thereof
11. Sesame seeds and products thereof
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2
13. Lupin and products thereof
14. Molluscs and products thereof

Your faithfully,
Name: Elżbieta Filutowska
Designation: Quality Department

12. Product Specification
Product name
Pharmaquinone®99% Active Ingredient
Vitamin K2 as MK-7
SKU codes
K2MK7
Vitamin K2 content
NLT 99.0% MK-7
Packaging
HDPE bottles intended for contact with food,protecting light-sensitive contents
Tests
Requirements
Method
Appearance
Yellow crystalline powder
Visual assessment
Identification
IR
HPLC
Corresponds to the standard IR spectrum
Corresponds to the standard HPLC profile
UPLC method* /
USP <621>
Assay of vitamin K2 (MK7)
Not less than 99.0% - not more than 101.0%
UPLC method*
Related substances Total impurities
Not more than 1.00%
UPLC method*
Assay of vitamin K2 (MK7)
Not less than 99.0% - not more than 101.0%
USP method
Isomeric purity Content of cis-menaquinone-7
No more than 1.00%
USP <621>
Loss on drying
Not more than 0.50%
Ph. Eur. <2.2.32>
Sulphated ash
Not more than 0.10%
Ph. Eur. <2.4.14>
Residual solvents
Acetone
Ethyl acetate

Not more than 1500 ppm
Not more than 500 ppm
Ph. Eur. <2.4.24> / USP <467>
Heavy metals
Arsenic***

Cadmium***

Lead***

Mercury***

Not more than 2 ppm

Not more than 1 ppm

Not more than 3 ppm

Not more than 0.1 ppm

Ph. Eur. <2.2.58> / USP <233>

* <A novel method for the determination of chemical purity and assay of menaquinone-7. Comparison with the methods from theofficial USP monograph> by Jedynak et al.
** BILE TOLERANT GRAM NEGATIVE BACTERIA INCLIDE ENTEROBACTERIACEAE, PSEUDOMONAS AND AEROMONAS
*** EVERY THIRD BATCH IS TESTED

Shelf life, storage and handling

36 months of date of production. The packed Product should be stored in temperature 5-25 °C andhumidity 20-70%. Protect from the light.
The product is very light sensitive and exposure may deteriorate K2 activity

The only „Single peak” vitamin K2
API 99% graph
13. Certificate of Analysis
Product name
Pharmaquinone® 99% Active Ingredient
Vitamin K2 as MK-7
SKU codes
K2MK7
Batch number
-
Manufacturing date
-
Retest date
-
Storage
The packed product should be stored in temperature 5-25°C and humidity 20-570%. Protect from light
Packaging
HDPE containers intended for contact with food, protecting light-sensitive contents
Tests
Requirements
Results
Description: Visual determination
Yellow crystalline powder
Complies
Identification
IR spectrum (KBr)
HPLC
Corresponds to the standard IR spectrum
Corresponds to the standard HPLC profile
Complies

Complies
Assay of vitamin K2 (MK7) (UPLC method*)
Not less than 99.0% - not more than 101.0%
-
Related substances (UPLC Method*) Total impurities
Not more than 1.00%
-
Assay of vitamin K2 (MK7) (USP method*)
Not less than 99.0% - not more than 101.0%
-
Isomeric purity (UPLC Method) Content of cis-menaquinone-7
Not more than 1.00%
-
Loss on drying
Not more than 0.50%
-
Sulphated ash
Not more than 0.10%
-
Residual solvents
Acetone
Ethyl acetate

Not more than 1500ppm
Not more than 500ppm
-
Heavy metals
Arsenic

Cadmium

Lead

Mercury

Not more than 2ppm

Not more than 1ppm

Not more than 3ppm

Not more than 0.1ppm
-
14. Flowchart
API 99% flowchart
15. Safety Data Sheet
1. Identification of the substance/mixture and of the company/undertaking
Product identifiers
Product name
Pharmaquinone®99% Active Ingredient
Vitamin K2 as MK-7
Product Number
K2MK7
Brand
VitaSynth Sp. z o. o.
CAS-No.:
2124-57-4
Recommended use
Food, dietary supplements
Identified uses
The manufacturing of food products, including food supplements, havebeen Generally Recognized as Safe (self-affirmed GRAS), meaning that they are safe for human consumption. In the European Union Pharmaquinone products are recognized as Generic Novel Foods.
Details of the supplier of the safety data sheet
Company
VitaSynth Sp. z o. o.
2 Szałwiowa Street
PL- 03-167 Warsaw
Telephone
+48 22 602 22 29
E-mail address
sales@pharmaquinone.com
Emergency telephone
Emergency Phone
+(48)-223988029 (CHEMTREC)
998 (fire department)
112 (emergency call center)
2. Hazards identification
Classification of the substance or mixture
Not a hazardous substance or mixture according to Regulation (EC) No 1272/2008.
Label elements
Not a hazardous substance or mixture according to Regulation (EC) No 1272/2008.
Other hazards
None known
3. Composition/information on ingredients
Substance:
Vitamin K2 (MK-7)
Synonyms:
Menaquinone-7
Formula:
C46H64O2
Molecular weight:
649 g/mol
CAS-No.:
2124-57-4
Content:
NLT 99%

No components need to be disclosed according to the applicable regulations.

4. First aid measures
Description of first-aid measures
Inhalation
If breathed in, move person into fresh air. If not breathing, give artificial respiration.
Skin contact
Wash off with soap and plenty of water
Eye contact
Flush eyes with water as a precaution.
Ingestion
Never give anything by mouth to an unconscious person. Rinse mouth withwater.
General information
In all cases of doubt, or when symptoms persist, seek medical advice.
Most important symptoms and effects, both acute and delayed

The most important known symptoms and effects are described in the labelling (see section 2) and/or in section 11

Indication of any immediate medical attention and special treatment needed

No data available

5. Firefighting measures
Extinguishing media

Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Special hazards arising from the substance or mixture

Carbon oxides

Advice for firefighters

Wear self-contained breathing apparatus for firefighting if necessary

Further information

No data available

6. Accidental release measures
Personal precautions, protective equipment and emergency procedures

Avoid dust formation. Avoid breathing vapors, mist or gas. For personal protection see section 8

Environmental precautions

Do not let product enter into soil or sewer.

Methods and materials for containment and cleaning up

Sweep up and shovel. Keep in suitable, closed containers for disposal.

Reference to other sections

For disposal see section 13.

7. Handling and storage
Precautions for safe handling

Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide adequate ventilation and local exhaust ventilation at places where dust is formed.

Conditions for safe storage, including any incompatibilities

Keep container tightly closed, may be stored in temperatures between 5 °C and 25 °C (RH: 20-70%). After opening the container, use as soon as possible or tightly close the container and store in refrigerator.Store in dark. Store away from incompatible materials such as oxidizing agents and materials with high alkaline levels.

Specific end use(s)

Apart from the uses mentioned in section 1 no other specific uses are stipulated.

8. Exposure controls/personal protection
Control parameters

Ingredients with workplace control parameters.

Exposure controls
Engineering controls used:
Handle in accordance with health and safety. Wash hands before breaks and at the completion of the work.
Individual protection measures, such as personal protective equipment
Eye/face protection
Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protection
Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.
The selected protective gloves have to satisfy the specifications of Regulation (EU) 2016/425 and the standard EN 374 derived from it.
Body protection
Choose body protection in relation to its type, to the concentration and amount of dangerous substances, and to the specific work-place., The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection
In case of insufficient ventilation, wear suitable respiratory equipment.
Control of environmental exposure:
No special environmental precautions required.
9. Physical and chemical properties
Information on basic physical and chemical properties
Appearance Form
Yellow crystalline powder
Odor
No data available
Odor Threshold
Odorless
pH
No data available
Melting point/freezing point
54 °C ÷ 55 °C
Initial boiling point and boiling range
No data available
Flash point
No data available
Evaporation rate
No data available
Flammability (solid, gas)
No data available
Upper/lower flammability or explosive limit
No data available
Vapor pressure
No data available
Vapor density
No data available
Relative density
No data available
Water solubility
Insoluble
Partition coefficient n-octanol/water
No data available
Auto-ignition temperature
No data available
Decomposition temperature
No data available
Viscosity
No data available
Explosive properties
Not explosive
Auto-ignition temperature
Not oxidizing
10. Stability and reactivity
Reactivity:
No data available
Chemical stability:
Stable under recommended storage conditions.
Possibility of hazardous reactions:
No data available
Conditions to avoid:
Protect from light. Keep away from sources of heat.
Incompatible materials:
Strong oxidizing agents.
Hazardous decomposition products
Hazardous decomposition products formed under fire conditions:
Carbon oxides
Other decomposition products:
No data available
In the event of fire:
See section 5
11. Toxicological information
Information on toxicological effects
Most likely routes of exposure
Skin and inhalation.
Symptoms
Potential irritation of respiratory tract or eyes. No known hazards by inhalation, skin or eye exposure.
Method
Risk assessment based on values and information of ingredients found in literature.
Skin irritation
Non-irritating
Eye irritation
Non-irritating
Acute dermal
No indication
Acute oral
LD50 more than 500 mg/kg
Inhalation
No indication
Sensitization
Not a sensitizer
Mutagenicity
Not mutagenic
Target organ effects
No indication
Carcinogenicity
No indication
Teratogenicity
No indication
12. Ecological information
Toxicity

Not expected to have significant environmental effects

Persistence and degradability

No data available

Bioaccumulative potential

No indication of bio-accumulation potential

Mobility in soil

No data available

Results of PBT and vPvB assessment

This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher

Other adverse effects

Negative ecological effects are not expected.

13. Disposal considerations
Waste treatment methods

Product
Offer surplus and non-recyclable solutions to a licensed disposal company.

Contaminated packaging
Contaminated packaging convey the established processors of waste.

14. Transport information
UN number
ADR/RID: -
IMDG: -
IATA: -
UN proper shipping name
ADR/RID:
Not dangerous goods
IMDG:
Not dangerous goods
IATA:
Not dangerous goods
Transport hazard class(es)
ADR/RID: -
IMDG: -
IATA: -
Packaging group
ADR/RID: -
IMDG: -
IATA: -
Environmental hazards
ADR/RID: no
IMDG Marine pollutant: no
IATA: no
Special precautions for user

No data available

15. Regulatory information
Safety, health and environmental regulations/legislation specific for the substance or mixture

Generic authorizations of Novel Foods:
Authorizations are no longer individual. Instead, authorized novel foods are added to the EU list, which serves as a so-called ‘positive list’. Every food business operator that complies with the conditions of the authorization can place the respective novel food on the market. Also the applicant-specific novel food authorizations under the old Regulation have been included in the European Union list. This led to an initial list containing 125 entries (numbers as mentioned on the website of the European Commission).

16. Other information
Further information

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by Road; AIIC- Australian Inventory of Industrial Chemicals; ASTM -American Society for the Testing of Materials; bw- Body weight; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardization; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rateresponse; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Codefor the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organization for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - LethalConcentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. -Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed(Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bio accumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of theCouncil concerning the Registration, Evaluation, Authorization and Restriction of Chemicals; RID -Regulations concerning the International Carriage of Dangerous Goods by Rail; SADT -Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN- United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative.

Further information

The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide.
The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions.
It does not represent any guarantee of the properties of other product. VitaSynth shall not be held liable for any damage resulting from handling or from contact with the above product.

16. Attachments
FDA/ CGMP STATEMENT

To whom it may concern,

We hereby confirm our various Menaquinone-7 products has been shipped to USA market under FDA supervision for several years. As a result, our Menaquinone-7 dilutions preparation site (sister company):

Europharma Alliance sp. z o. o.AL. LED 1, 55-020 Rzeplin, Poland

has been audited by FDA on 9th and 10th of October, 2019. It was a comprehensive surveillance inspection of foreign dietary supplement raw material manufacturer conducted in accordance with PAC0314, CGMP/Limited Scope PCHF Inspections, with Operation ID 126761. This inspection covered manufacturing of Vitamin K2 bulk premix as dietary ingredient requiring further processing. Inspection of raw ingredient/material receiving, quarantine, batch production, master manufacturing records, sanitation, quality and complaints produced 0 FDA 483 Inspectional Observations. No complaints regarding the firm were found in FACTS. FDA “closed” inspection under 21 CFR 20.64(d)(3).

Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

NON-GMO STATEMENT

To whom it may concern,

VitaSynth sp. z o. o. takes every precaution to manufacture and provide safe and functional product range under the trademark: Pharmaquinone®, Vitamin K2 as MK-7 used in the food and chemical industry.

To the best of our knowledge, the product listed above is not derived from genetically modified starting raw materials, or additives that are derived from genetically modified organisms, and do not contain detectable levels of genetically modified materials (known as PCR negative) in compliance with EU Regulation No 1829/2003, including amended EU Directive 2001/18/EC.

Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

BST/BSE FREE STATEMENT

To whom it may concern,

VitaSynth sp. z o. o. takes every precaution to manufacture and provide safe and functional product range under the trademark: Pharmaquinone®, Vitamin K2 as MK-7 used in the food and chemical industry.

The manufacturing process does not use any ingredient of animal origin nor do our products come in contact with animal products during storage and transportation. To the best of our knowledge, the product listed above is free from Transmissible Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE) in compliance with good manufacturing practice and EU Regulation (EC) No 999/2001.

Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

FAQ
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1. What is MOQ?

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2. What's the shipping time?

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1. What transportation methods does our company have?

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4. Can you supply the free sample?

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5. Does our company support third party testing?

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1. Product Information Data Sheet

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2. Packaging specification

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3. Product specification

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4. Analytical instructions

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5. Dilution preparation instructions

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6. Catalogue

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Pharmaquinone logo
Manufacturer: VitaSynth Sp. z o.o. ul. Szałwiowa 2, 03-167 Warsaw, Poland
Dilutions site: EuroPharma Alliance Sp. z o.o. Aleja Led 1, 55-020 Rzeplin, Poland
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