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Pharmaquinone®0.2% MCC Powder Vitamin K2 as MK-7

Pharmaquinone® 0.2% MCC Powder Vitamin K2 as MK-7

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Essential details
Product name
Pharmaquinone®0.2% MCC Powder Vitamin K2 as MK-7
SKU code
020P
Chemical names
Menaquinone-7 (MK-7)
Common name
Vitamin K2
General product information
Synthetic Vitamin K2 as MK-7 in MCC oil for use in food and dietary supplements
Country of origin
Poland
Manufacturer
Vitasynth
Dilution site
Europharma Alliance, Poland
Sample
Available
Our certificates
FDA logotype
Industry standard
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halal logotype
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Delivery
Packaging & labelling
Polyethylene Zip  lock  bag inside  a  silver,  aluminum-based doypack with appropriate labelling
Storage conditions
The packaged product should be stored at 5-25°C / 41-77°F and 30-50% 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
020P2307-1
020P - 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
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1. Product Information Data Sheet

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2. Product specification

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4. Catalogue

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5. Pharmaquinone Leaflet

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Sample Certificate of Analysis
Tests
Requirements
Results
Appearance
Light yellow to yellow powder
Complies
Identification
Corresponds to the standard HPLC profile
Complies
Total Vitamin K2 as MK-7 (UPLC Method*)
> 0.20 % or > 2 000 ppm
0.23 %
Related substances (UPLC Method*) Total impurities
≤ 1.50 %
0.56 %
Total Vitamin K2 as MK-7 (USP method)
> 0.20 % or > 2 000 ppm
0.22 %
Isomeric purity (UPLC Method) Content of cis-menaquinone-7
≤ 1.50%
Not detected
Particle size
100% passes through 40 mesh
Complies
Bulk density
0.3 – 0.55 g/ml
0.314 g/ml
Water solubility
Insoluble
Complies
Loss of drying (105˚C/ 4h)
≤ 8.0 %
3.80 %
Heavy metals
Arsenic

Cadmium

Lead

Mercury

≤ 0.5 ppm

≤ 0.3 ppm

≤ 0.5 ppm

≤ 0.1 ppm

< 0.010 ppm

< 0.001 ppm

0.026 ppm

0.0022 ppm
Microbiological parameters
TAMC in 1g

TYMC in 1g

E. Coli in 1g

Salmonella in 25 g

Staphylococcus aureus in 1g

Bile tolerant gram negative bacteria**in 1g

≤ 1 x 103 CFU

≤ 1 x 102 CFU

Absent

Absent

Absent

≤ 1 x 102 CFU

1.0 x 101 CFU

< 1.0 x 101 CFU

Absent

Absent

Absent

< 1.0 x 101 CFU
Product Information Data Sheet
Pharmaquinone logo

Pharmaquinone®0.2% MCC Powder Vitamin K2 as MK-7

1. Product Identity and Form
Product name
Pharmaquinone®0.2% MCC Powder Vitamin K2 as MK-7
SKU code
020P
Chemical names
Menaquinone-7 (MK-7)
Common name
Vitamin K2
General product information
Synthetic Vitamin K2 as MK-7 in MCC Powder 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 is responsible for Vitamin K2 quality and control EuroPharma Alliance, ul. Al. LED 1, 55-020 Rzeplin, Poland (sister company of VitaSynth, CMO facility)
Manufacturing process
Pure K2 vitamin is mixed with MCT oil in a prolonged process and controlled heating. The  oil  obtained  in  the  process  is combined  with  MCC.  The  powder  concentrate  is  further mixed with MCC to a given concentration.
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
Polyethylene Zip  lock  bag inside  a  silver,  aluminum-based doypack with appropriate labelling
Storage conditions
The packaged product should be stored at 5-25°C / 41-77°F and 30-50% 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
020P2307-1
020P - 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
TÜV Rheinland
03.01.2026
ISO (FSSC22000)
Certified
TÜV Rheinland
03.01.2026
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.

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
CAS
2000ppm
Origin
GMO status
Menaquinone-7
2124-57-4
0.2%
Chemical synthesis
non-GMO
Medium chain triglyceride oil (MCT)
73398-61-5
1.8%
Vegetable origin
non-GMO
Microcrystalline cellulose (MCC)
9004-34-6
98.0%
Vegetable origin
non-GMO
9. Nutritional Profile*
Component
Typical value per 100 g
Total calories
12.2 Kcal
Total proteins
0.00 g
Total fat
1.8 g
Dietary fiber
98.0 g
Total sugars
0.00 g
Carbohydrates
0.00 g
Salt
0.00 g
Vitamin K2 as MK7
2000 ppm
* 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
Yes
Crustaceans and products thereof
No
Yes
Eggs and products thereof
No
No
Fish and products thereof
No
Yes
Peanuts and products thereof
No
No
Soybeans and products thereof
No
Yes
Milk and products thereof (including lactose)
No
Yes
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
Yes
Lupin and products thereof
No
No
Molluscs and products thereof
No
Yes
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®0.2% MCC Powder
Vitamin K2 as MK-7
SKU codes
020P
Vitamin K2 content
NLT 10.000 mg K2 as MK-7/g
Packaging
1 kg or 5 kg of Product in 3 mil polyethylene „slider zip” bag inside a silver, aluminum-based doypack
Tests
Requirements
Method
Appearance
Light yellow to yellow powder
Visual assessment
Identification
Corresponds to the standard HPLC profile
UPLC method* /
USP <621>
Total Vitamin K2 as MK-7
> 0.20% or > 2000 ppm
UPLC method*
Related substances Total impurities
Not more than 1.50%
UPLC method*
Total Vitamin K2 as MK-7
> 0.20% or > 2000 ppm
USP <621>
Isomeric purity Content of cis-menaquinone-7
≤ 1.50%
USP <621>
Particle size
100% passes through 40 mesh
USP <786>
Bulk density
0.3 –0.55 g/ml
Ph. Eur. <2.9.34> / USP<616>
Water solubility
Insoluble
Ph. Eur. <General notices / USP <General notices>
Loss of drying (105 ̊C/ 4h)
≤ 8.0%
Ph. Eur. <2.2.32>
Weight tolerance limit
Not less than 100% of the declared weight
Each unit container is weighed Sampling/emptying allowance is added to each unit container
Uniformity of mix
All samples must pass assay test
n + 1 unit containers are drawnfrom each production batch
Heavy metals
Arsenic***

Cadmium***

Lead***

Mercury***

≤ 0.5 ppm

≤ 0.3 ppm

≤ 0.5 ppm

≤ 0.1 ppm

Ph. Eur. <2.2.58> / USP <233>
Ph. Eur. <2.2.58> / USP <233>
Ph. Eur. <2.2.58> / USP <233>
Ph. Eur. <2.2.58> / USP <233>
Microbiological parameters
TAMC in 1g

TYMC in 1g

E. Coli in 1g

Salmonella in 25 g

Staphylococcus aureus in 1g
Bile tolerant gram negative bacteria**in 1g

≤ 1 x 103 CFU

≤ 1 x 102 CFU

Absent

Absent

Absent

≤ 1 x 102 CFU

Ph. Eur. <2.6.12> / USP <2021>
Ph. Eur. <2.6.12> / USP <2021>
Ph. Eur. <2.6.13> / USP <2022>
Ph. Eur. <2.6.13> / USP <2022>
Ph. Eur. <2.6.13> / USP <2022>
Ph. Eur. <2.6.13> / USP <2021>

* <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

30 months of date of production. The packed Product should be stored in temperature 5-25 °C andhumidity 30-50%. Protect from the light.
The product is very light sensitive and exposure may deteriorate K2 activity

The only „Single peak” vitamin K2
0.2% powder graph
13. Certificate of Analysis
Product name
Pharmaquinone®0.2 % MCC Powder
Vitamin K2 as MK-7
SKU codes
020P
Batch number
-
Best before
30 months from manufacture
Manufacturing date
-
Expiry date
-
Storage
The packed product should be stored in temperature 5-25°C and humidity 30-50%. Protect from light
Packaging
unit doypack with zipper bag
Tests
Requirements
Results
Appearance
Light yellow to yellow powder
Complies
Identification
Corresponds to the standard HPLC profile
Complies
Total Vitamin K2 as MK-7 (UPLC Method*)
> 0.20% or > 2 000 ppm
-
Related substances (UPLC Method*) Total impurities
≤ 1.50%
-
Total Vitamin K2 as MK-7 (UPLC Method)
> 0.20% or > 2 000 ppm
-
Isomeric purity (UPLC Method) Content of cis-menaquinone-7
≤ 1.50%
-
Particle size
100% passes through 40 mesh
-
Bulk density
0.3 - 0.55 g/ml
-
Water solubility
Insoluble
-
Loss of drying (105 ̊C/ 4h)
≤ 8.0%
-
Heavy metals
Arsenic

Cadmium

Lead

Mercury

≤ 0.5 ppm

≤ 0.3 ppm

≤ 0.5 ppm

≤ 0.1 ppm
-
Microbiological parameters
TAMC in 1g

TYMC in 1g

E. Coli in 1g

Salmonella in 25 g

Staphylococcus aureus in 1g
Bile tolerant gram negative bacteria**in 1g

≤ 1 x 103 CFU

≤ 1 x 102 CFU

Absent

Absent

Absent

≤ 1 x 102 CFU
-

* <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

14. Flowchart
0.2% powder flowchart
15. Safety Data Sheet
1. Identification of the substance/mixture and of the company/undertaking
Product identifiers
Product name
Pharmaquinone®0.2% MCC Powder
Vitamin K2 as MK-7
Product Number
020P
Brand
VitaSynth Sp. z o. o.
Recommended use
Food, dietary supplements
Identified uses
The manufacturing of food products, including food supplements, have been 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
Name ingredient
CAS
concetration
Menaquinone-7
2124-57-4
0.2%
Medium chain triglyceride oil (MCT)
73398-61-5
1.8%
Microcrystalline cellulose (MCC)
9004-34-6
98%

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

4. First aid measures
Description of first-aid measures
Inhalation
Move to fresh air. Call a physician if symptoms develop or persist.
Skin contact
Wash off with soap and water. Get medical attention if irritation developsand persists.
Eye contact
Rinse with water. Get medical attention if irritation develops and persists
Ingestion
Persons receiving anticoagulant therapy, like warfarin or coumarins, should notify their physician. Product contains vitamin K which interferes with the biological activity of some anticoagulants.
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

Treat symptoms. Product has low, dermal, inhalation toxicity and is non-irritating to eye and skin.

5. Firefighting measures
Extinguishing media

Carbon dioxide (CO2). Foam. Dry extinguishing powder. Do not use water.

Special hazards arising from the substance or mixture

During fire, gases hazardous to health may be formed.

Advice for firefighters

Self-contained breathing apparatus and full protective clothing must be worn in case of fire.

Further information

Use standard firefighting procedures and consider the hazards of other involved materials.No unusual fire or explosion hazards noted.

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

Keep unnecessary personnel away. For personal protection see section 8.

Environmental precautions

Avoid discharge into drains, water courses or onto the ground.

Methods and materials for containment and cleaning up

Sweep up using spill control material, collect and dispose appropriately.

Reference to other sections

For disposal see section 13.

7. Handling and storage
Precautions for safe handling

Observe good industrial hygiene practices.

Conditions for safe storage, including any incompatibilities

Keep container tightly closed, may be stored in temperatures between 5 °C and 25 °C (RH: 30-50%). 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
Specific end use(s)
Substance:
Cellulose
CAS-No.:
9004-34-6
EC-No. (EINECS/ELINCS):
232-674-9
OEL (CA-QUEBEC, CA ONTARIO, NZ):
10 mg/m³
OEL (GB):
10 mg/m³ inhalable aerosol; 4 mg/m³ respirable aerosol
OEL (NZ):
10 mg/m³
OEL (US-OSHA):
15 mg/m³ total dust; 5 mg/m³ respirable dust
Engineering controls:
Good general ventilation should be used. Ventilation rates should  be  matched  to  conditions. Respiratory  protection required in the case of dust formation.
Individual protection measures, such as personal protective equipment
Eye/face protection
Safety glasses or chemical goggle
Hand and skin protection
Appropriate  dust  resistant  clothing  and  protective  gloves. No special gloves are required.
Respiratory protection
Dust   mask   or   respirator   approved   by   NIOSH/MSHA   is required (in the absence of proper environmental controls).
Thermal hazard
Not available.
General hygiene considerations

Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.

9. Physical and chemical properties
Information on basic physical and chemical properties
Appearance Form
Light yellow to yellow powder
Odor
No data available
Odor Threshold
No data available
pH
5-7
Melting point/freezing point
~23 °F (-5 °C)
Initial boiling point and boiling range
Not applicable
Flash point
Not determined
Evaporation rate
Not applicable
Flammability (solid, gas)
Not applicable
Upper/lower flammability or explosive limit
Approx. 30 g/m3 / Approx. 11 g/m3
Oxidizing characteristics
Not oxidizing
Vapor pressure
Not applicable
Vapor density
Not applicable
Density (in 20˚C)
0.3 –0.55 g/ml
Water solubility
Insoluble
Organic solvents
0%
Partition coefficient n-octanol/water
Not determined
Auto-ignition temperature
Not applicable
Decomposition temperature
Approx. 200°C
Viscosity
Not applicable
Explosive properties
Potential dust explosive
Auto-ignition temperature
Not determined
10. Stability and reactivity
Reactivity

The product is stable and non-reactive under normal conditions of use, storage and transport.

Chemical stability

This product is stable under normal conditions.

Possibility of hazardous reactions

No dangerous reaction known under conditions of normal use.

Conditions to avoid

Protect from light. Keep away from sources of heat.

Incompatible materials

Strong oxidizing agents. This product may react with strong alkalies.

Hazardous decomposition products

At high temperatures acrolein may be formed. 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
> 5000 mg/kg
Inhalation
> 5.8 mg/l/4hrs
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

Readily biodegradable

Bioaccumulative potential

No indication of bio-accumulation potential.

Mobility in soil

No data available

Results of PBT and vPvB assessment

This substance does not meet the criteria for classification as PBT or vPvB.

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

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 incontact 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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2. Packaging specification

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2. Product specification

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3. Analytical instructions

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4. Catalogue

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5. Pharmaquinone Leaflet

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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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