Raw Material Specification Template

PRODUCT TECHNICAL DOSSIER
VITAMIN B3 NICOTINAMIDE
Product Code:
P2210
Raw Material Full Name:
Vitamin B3 Nicotinamide
Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms:
Vitamin B3, Vitamin PP, Niacinamide, Pyridine -3- Carboxyamide.
This material is Food Grade:
Yes
Vegan / Vegetarian Status:
Yes
Limit/Range/Specification:
98.5% - 101.5%
CAS Number:
98-92-0
EC/EINECS Number:
202-713-4
Molecular Formula for the raw material:
C6H6N2O
Average Molecular weight:
122.13g/mol
Solubility in Water:
1g Nicotinamide dissolved in 10ml water
Product Code: P2210
Version: 3
Page 1 of 14
Solubility in Alcohol:
1g Nicotinamide dissolved in 10ml Alcohol
Particle Size:
100%Pass 40 Meshes
98% Pass 60 Meshes
80% Pass 80 Meshes
Bulk Density:
0.5023g/m3
Tapped Density:
0.6218g/m3
pH:
6.0-7.5
Loss on Drying:
Max 0.5%
Residue on Ignition:
Max 0.1%
Country of Origin:
China/India
Country of Origin of the Manufacture:
China
Base Source/Start Material:
3 – Cyanopyridine
Origin of Product – Synthetic, Plant, Mineral, Animal, Fish or Fermented:
Synthetic
Synthetic: What are the starting materials of the synthesis and their sources?
3 – Cyanopyridine
Product Code: P2210
Version: 3
Page 2 of 14
Material is:
100%
Compound Ingredients Origin, Function and Percentages:
None
Shelf Life from Date of Manufacture:
3 Years from date of manufacture
Storage Conditions:
Store under normal conditions keep away from light.
Appearance (Fine/Crystals/Crystalline/Hygroscopic):
Crystalline Powder
Colour:
White to Off White
Flavour/Taste:
Characteristic
Odour:
Characteristic
Microbiological Test
Total Viable Count:
Max 1,000cfu/g
Yeast & Moulds:
Max 100cfu/g
E.Coli:
Negative in 10g
Salmonella:
Negative in 25g
Product Code: P2210
Version: 3
Page 3 of 14
Heavy Metals
Lead (Pb):
Max 3ppm
Cadmium (Cd):
Max 1ppm
Pharmacopeia Standard Used:
EP, USP, FCC, BP, CP, JP
There are no nuts in this recipe; however we cannot guarantee that the raw materials entering the site are nut
free.
Please note that surveillance testing may mean that not all the parameters stated on this specification are
tested for every batch.
Product Code: P2210
Version: 3
Page 4 of 14
INTOLERANCE DATA
If No please give details
Free from All Animal Products (Beef, Pork, Poultry or other)
Free from Bovine Products or Derivatives by using hormones to increase milk yield in cows
Free from Bone Meal
Free from Peanuts and Peanut Derivatives (including possible cross contamination)
Free from other Nut and Nut Derivatives
Free from Nut Derived Oil
Free from Sesame Seeds and Sesame Seed Derivatives
Free from Poppy Seeds and Poppy Seed Derivatives
Free from Sunflower Seeds and Sunflower Seeds Derivatives
Free from other Seeds and Seed Derivatives
Free from Milk and Milk Derivatives (including lactose)
Free from Egg and Egg Derivatives
Free from Cereals containing Gluten (wheat / rye / oats / barley/ spelt/ kamut or their hybridised strains) and
Derivatives
Free from Soya and Soya Derivatives
Free from Maize and Maize Derivatives
Free from Corn and Corn Derivatives
Free from Lupin and Lupin Derivatives
Free from Yeast and Yeast Derivatives
Free from Cotton Seeds (Flour) and Cotton Seed Derivatives
Free from Rice and Rice Derivatives
Free from Mustard and Mustard Derivatives
Free from Celery or Celery Derivatives
Free from Celeriac or Celeriac Derivatives
Free from Fruit and Fruit Derivatives
Free from Vegetable and Vegetable Derivatives
Free from Carrot and Carrot Derivatives
Free from Legumes / Pulses
Free from Fish and Fish Derivatives
Free from Crustaceans / Molluscs and their Derivatives
Free from Additives
Free from Added Salt
Free from Added Sugar
Free from Antioxidants
Free from Artificial Glutamates
Free from Aspartame
Free from Azo and Coal Tar Dyes
Free from Benzoates (E210 / E219)
Free from BHA / BHT (E320 / E321)
Free from Caffeine
Free from Cinnamon
Free from Cocoa
Free from Colours (Artificial / Nature Identical / Natural / Smoked)
Free from Dextrose
Free from Dioxins
Product Code: P2210
Version: 3
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Page 5 of 14
Free from Ethanol
YES
INTOLERANCE DATA
If No please give
details
Free from Ethylene Oxide
Free from Flavourings (Artificial / Nature Identical / Natural / Smoked)
Free from Garlic
Free from Gelatine
Free from Glutamates (E620 to E625)
Free from Histamine
Free from Hickory
Free from Honey
Free from Lactose
Free from Latex
Free from MSG (Added and Naturally Occurring E621)
Free from Nucleotides (E627, E630, E631, E635)
Free from Polyols
Free from Preservatives
Free from Starch Products (Including Maltodextrin)
Free from Sorbic Acid (E200, E203)
2
Free from Sulphur Dioxide and Sulphites at levels above 10mg/kg or 10mg/litre expressed as SO
Free from Sulphites (E220, E228)
Free from Sweeteners
Free from Vannillin
Suitable for Diabetics
Suitable for Coeliacs
Suitable for Ovo-Lacto Vegetarians
Suitable for Vegans
Kosher Certified
Halal Certified
Product Code: P2210
Version: 3
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
NO
Kosher Certified
Not certified
Page 6 of 14
PRODUCTION FLOW CHART
3 Cyanopyridine
Hydrolysis
Purified Water
Filter Pressing
Decolouration
Filter Pressing
Crystalization
Filtration
Sifting
Packaging
Nicotinamide
Product Code: P2210
Version: 3
Page 7 of 14
CONFIRMATION OF BSE/TSE STATUS
This is to certify that this product complies with all relevant current UK and EU Legislative requirements in
regard to Transmissible Spongiform Encephalopathies (TSE) and Bovine Spongiform Encephalopathy (BSE)
for human food, and so is free of TSE/BSE.
This is also to certify that, during the course of their manufacture, the above-mentioned product did not
come into contact with any materials, which could be derived from TSE/BSE risk materials.
CONFIRMATION OF GM STATUS
This is to certify that this product is not manufactured from GM raw materials and is therefore not subject
to labelling under regulations 1829/2003/EC and 1830/2003/EC.
CONFIRMATION OF NON IRRADIATION STATUS
This is to certify that this product, whole or in part, has not been subjected to Ionising Radiation as per
European Directives 1999/3/EC.
CONFIRMATION OF NANDROLONE STATUS
This is to certify that this product, whole or in part, has not come into contact with Nandrolone or any of
its precursors in any way.
CONFIRMATION OF IOC PRODUCT STATUS
This is to certify that this product, whole or in part, has not come into contact with any product/s, which is
banned by the IOC (International Olympics Committee) and or WADA.
CONFIRMATION OF ANIMAL TESTING STATUS
This is to certify that all the products sold by Cambridge Commodities have not been tested on animals in
any part of its manufacture in accordance with regulation 86/609/EEC.
CONFIRMATION OF PESTICIDES STATUS
This is to certify that the above-mentioned product complies with the regulation (EC) No.396/2005 of 23rd
February 2005 and commission Regulation (EU) No. 559/2011 of 7th June 2011 amending annexes II and III
of the above Regulation.
CONFIRMATION OF NANOPARTICLE STATUS
This is to certify that unless otherwise stated, the above-mentioned product is free of nanoparticles.
Commission Recommendation 2011/696/EU, defines as follows: "'Nanomaterial' means a natural,
incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an
agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more
external dimensions is in the size range 1 nm - 100 nm".
Product Code: P2210
Version: 3
Page 8 of 14
MATERIAL SAFETY DATA SHEET
Section 1 Identification of the Substance/Mixture and of the Company/Undertaking
Product name:
Chemical formula:
Synonym:
Catalog #:
Company:
Vitamin B3 Nicotinamide
C6H6N2O
N/A
P2210
Cambridge Commodities Limited
Lancaster Way, Ely, Cambridgeshire, CB6 3NX
Tel: 01353 667258. Email: [email protected]
Section 2 Hazards Identification
Irritant
Target organs
HMIS rating
NFPA Rating
Irritating to eyes, Respiratory system and skin.
Eyes. Kidneys
Health: 2*
Flammability : 0
Reactivity: 0
Health: 2
Flammability: 0
Reactivity: 0
*Additional chronic hazards present.
For additional information on toxicity, please refer to section 11.
Section 3 Composition/Information on Ingredients
Components
Vitamin B3 Nicotinamide
% in Product
100
CAS Number
98-92-0
Formula
C6H6N2O
EINECS Number
202-713-4
Section 4 Emergency and First Aid Measures
Eyes
Skin
Product Code: P2210
in the case of contact immediately flush eyes with copious amounts
of water for at least fifteen minutes.
In the case of contact, immediately wash skin with soap and copious
amounts of water.
Version: 3
Page 9 of 14
Swallowing
Inhalation
If swallowed, wash out mouth with water provided person is
conscious. Call a physician.
If inhaled remove to the fresh air. If not breathing give artificial
respiration. If breathing is difficult give oxygen.
Section 5 Fire-fighting measures
Flash Point
Auto ignition temp:
Flammability
Extinguishing Media
Fire Fighting Instructions
Specific Hazard(s)
302°F 150°C
Method: Closed cup
No Data Available
No Data Available
Foam, water spray, carbon dioxide, dry chemical powder.
Wear a self-contained breathing apparatus and protective clothing
to prevent contact with skin and eyes.
Emits toxic fumes under fire conditions.
Section 6 Accidental Release Measures
Procedures of personal precaution
Cleaning up Methods
Wear respirator, chemical safety goggles, rubber boots and heavy
rubber gloves.
Sweep up, place in a bag and hold for waste disposal. Avoid raising
dust. Ventilate area and wash spill site after material pickup is
complete.
Section 7 Handling and Storage
Handling
Storage
Do not breathe in dust. Avoid contact with eyes, skin, and clothing.
Avoid prolonged or repeated exposure.
Keep tightly Closed.
Section 8 Exposure Controls/Personal Protection
Engineering Measures:
Respiratory Protection
Hand/Body Protection
Eye Protection
Product Code: P2210
Safety shower and eye bath. Mechanical exhaust required.
Government approved respirator.
Compatible chemical resistant gloves.
Chemical Safety Goggles
Version: 3
Page 10 of 14
Section 9 Physical and Chemical Properties
Physical state
Colour
Odour
Solubility
Sieve Analysis
Crystalline Powder
White/Off White
Characteristic
Soluble in both water and alcohol.
100% pass 40 Meshes
98% pass 60 Meshes
80% Pass 80 Meshes
Section 10 Stability and Reactivity
Chemical Stability
Hazardous Polymerisation
Incompatibility
Hazardous Decomposition Products
Stable
Product will not undergo hazardous polymerisation.
Strong oxidising agents.
May form Carbon Dioxide, Carbon Monoxide and Nitrogen
oxides.
Section 11 Toxicological Information
Routes Of Exposure
Skin Contact
Skin Absorption
Eye Contact
Inhalation
Ingestion
Target Organs
Signs and symptoms of exposure.
Conditions aggravated by exposure
Toxicity Data
Product Code: P2210
Causes Skin Irritation
May be harmful if absorbed through skin
Causes Eye irritation
May be harmful in inhaled, Material is irritation to mucous
membranes and upper respiratory tract.
Harmful if swallowed in large amounts
Liver. Eyes . Kidneys.
Other symptoms of exposure can include anorexia, excessive
Salivation, Pupillary Construction, Bronchoconstriction, Respiratory
failure. Tightness of the chest, coma, pulmonary, ureter and bladder
effects. To the best of our knowledge the chemical, physical and
toxicological properties have not been thoroughly investigated.
May Produce reversible liver damage
Oral
Rat
Oral
Rat
Version: 3
Page 11 of 14
Remarks
Toxicity Data
3500mg/kg
3500mg/kg
LD50
LD50
Subcutaneous
Subcutaneous
Rat
Rat
1680MG/KG
1680MG/KG
LD50
LD50
Lungs, Thorax, or Respiration: other changes. Lungs, Thorax, or
respiration: other Changes
Oral
Oral
Mouse
Mouse
2500Mg/kg
2500Mg/kg
LD50
LD50
Intraperitoneal
Intraperitoneal
Mouse
2050Mg/kg
LD50
Subcutaneous
Mouse
2GM/KG
LD50
Mouse
2050Mg/kg
LD50
Subcutaneous
Mouse
2GM/KG
LD50
Species
Dose
Cell type
Mutation Test
Human
10MMOL/L
Lymphoycte
Sister Chromatid
Exchange
Rat
20MMOL
Liver
DNA Inhibition
Human
10MMOL/L
Lymphoycte
Sister Chromatid
Exchange
Rat
20MMOL
Liver
DNA Inhibition
Species
Dose
Cell Type
Mutation test
Rat
25mg/kg
Ovary
Body fluid Assay
Rat
25mg/kg
Ovary
Body Fluid Assay
Chronic Exposure - Mutagen
Species
Dose
Cell Type
Mutation Test
Product Code: P2210
Version: 3
Page 12 of 14
Species
Dose
Cell type
Mutation Test
Hamster
5MMOL/L
Ovary
Sister Chromatid
Exchange
Hamster
5MMOL/L
Ovary
Sister Chromatid
Exchange
Section 12 Ecological Information
Eco-toxicity
No Data Available
Section 13 Disposal Considerations
Waste from residues
Dissolve or mix material with a combustible solvent and burn in
a chemical incinerator equipped with an afterburner and scrubber.
Observe all federal, state, and local environmental regulations.
Section 14 Transport Information
Transport classification
Not classified as dangerous for any mode of UK or International
transport.
Section 15 Regulatory Information
European Regulation
Safety Statements
Symbol of danger Xi Irritant R 36/37/38.
May be irritating to respiratory system and skin S 26/36.
in case of contact with eyes rinse immediately with plenty of water
and seek medical advice. Wear suitable protective clothing
Section 16 Other Information
Product Code: P2210
Version: 3
Page 13 of 14
This advice is given by Cambridge Commodities Ltd who accepts no legal liability for it. The information
contained herein is based on the present state of our knowledge and is intended to describe our products
from the point of view of safety requirements. It should not therefore be construed as guaranteeing specific
properties.
Individuals working with chemicals should consider all chemicals to be potentially hazardous even if their
individual hazards may be uncharacterised or unknown.
This Information provided in this document is subject to change and the batch specific Certificate of
Analysis should always be referenced.
To be used as per local legislation.
Change History
Version
Change
1
2
First Issue
Updated format corrected spelling error in title and added Kosher
status
Clerical error MSDS (Vitamin B3)
3
Customer Notification
required Yes / No
N/A
No
No
Document Approval
Originator Job Title
Quality Specialist
Assistant Quality
Manager
Hannah Pritchard (Mar 10, 2016)
Lucia Valle (Mar 9, 2016)
Product Code: P2210
Approver Job Title
Version: 3
Page 14 of 14
P2210-Vitamin B3
Nicotinamide-Technical
Dossier
Adobe Document Cloud Document
History
3/10/16
Created:
3/9/16
By:
Hannah Pritchard ([email protected])
Status:
SIGNED
Transaction ID:
CBJCHBCAABAAB63kkQdtP7_SM7k9PyW5guKsYyB5082m
“P2210-Vitamin B3 Nicotinamide-Technical Dossier” History
Document uploaded by Hannah Pritchard ([email protected]) from Reader
3/9/16 - 5:58:18 PST - IP address: 81.145.42.226
Document emailed to Lucia Valle ([email protected]) for signature
3/9/16 - 5:58:21 PST
Document viewed by Lucia Valle ([email protected])
3/9/16 - 6:31:59 PST - IP address: 81.145.42.226
Document e-signed by Lucia Valle ([email protected])
Signature Date: 3/9/16 - 6:32:23 PST - Time Source: server - IP address: 81.145.42.226
Document emailed to Hannah Pritchard ([email protected]) for signature
3/9/16 - 6:32:24 PST
Document viewed by Hannah Pritchard ([email protected])
3/10/16 - 4:52:12 PST - IP address: 81.145.42.226
Document e-signed by Hannah Pritchard ([email protected])
Signature Date: 3/10/16 - 4:52:33 PST - Time Source: server - IP address: 81.145.42.226
Signed document emailed to Hannah Pritchard ([email protected]) and Lucia Valle
([email protected])
3/10/16 - 4:52:33 PST