Technical Dossier - Cambridge Commodities Ltd

PRODUCT TECHNICAL DOSSIER
VITAMIN C DC 97% (ASCORBIC ACID)
Product Code:
P22155
Raw Material Full Name:
Ascorbic Acid 97% Granular
Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms:
L-threo-hex-2-enoic acid Ɣ – lactone
This material is Food Grade

Limit/Range/Specification:
96% - 98% Ascorbic Acid (Iodine Titration)
CAS Number:
50-81-7
EC/EINECS Number:
E300
Molecular Formula for the raw material:
C6 H8 O6
Average Molecular weight:
176.13 g/mol
Solubility in Water:
Soluble
Solubility in Alcohol:
Soluble
Particle Size:
Min 95% Pass 20 Mesh
Max 30% Pass 100 Mesh
Product Code: P22155
Version: 2
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Bulk Density:
≥0.70g/ml
Tapped Density:
≥0.85g/ml
Specific Gravity:
≥0.70g/ml
pH:
2.1 – 2.6
Loss on Drying:
< 0.25%
Residue on Ignition:
< 0.1%
Country of Origin:
China
Country of Origin of the Manufacture:
China
Base Source/Start Material:
Fermented From Sorbitol (Corn)
Origin of Product – Synthetic, Plant, Mineral, Animal, Fish or Fermented:
Fermented
What is the extraction/processing used? What solvents are used and at what ratio’s?
Water
Compound Ingredients Origin, Function and Percentages:
2.0% - 4.0% (HPMC)
Shelf Life from Date of Manufacture:
3 year
Storage Conditions:
In closed containers, protected from humidity, at room temperature
Product Code: P22155
Version: 2
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Appearance (Fine/Crystals/Crystalline/Hygroscopic):
Free Flowing Granular Powder
Colour:
White/Off White/Yellowish
Flavour/Taste:
Sharp acidic pleasant taste
Odour:
Almost odourless
Microbiological Test
Total Viable Count:
Max 1,000cfu/g
Yeast & Moulds:
Max 100cfu/g
E.Coli:
Negative
Salmonella:
Negative
Staphylococcus:
Negative
Heavy Metals
Heavy Metals:
Max 10ppm
Arsenic (As):
Max 3ppm
Pharmacopeia Standard Used:
USP/FCC/Ph/Eur
Product Code: P22155
Version: 2
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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: P22155
Version: 2
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INTOLERANCE DATA
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
Free from Ethanol
Product Code: P22155
Version: 2
If No please give details
YES
YES
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NO
NO
Base Starting Material
Base Starting Material
YES
YES
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INTOLERANCE DATA
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: P22155
Version: 2
If No please give details
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
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NO
HPMC 2 – 4%
NO
NO
Not Certified
Not Certified
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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 1999/2/EC and 1000/3/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).
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.
Product Code: P22155
Version: 2
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MATERIAL SAFETY DATA SHEET
1. Identification of the substance/preparation
PRODUCT NAME:
VITAMIN C DC 97% (ASCORBIC ACID)
PRODUCT CODE:
P22155
Supplier:
Cambridge Commodities Limited
Lancaster Way Business Park, Ely, Cambridgeshire,
CB6 3NX.
Tel: 01353 667258. Email: [email protected]
Section 2 Ingredients/Identity Information
Characterization
Especially suited for direct compression of tablets
Chemical Name
L-threo-hex-2-enoic acid Ɣ – lactone; 3-oxo-L-gulofuranolactone
(enol form)
Synonyms
L-ascorbic acid, L-xylo-ascorbic acid, L-(+)-ascorbic acid; Vitamin C
CAS Number
50-81-7
Empirical Formula
C6H8O6
Molecular Mass
176.13 g/mol
Section 3 Possible Hazards
Most Important Hazards
No particular hazards known
Section 4 Emergency and First Aid Procedures
Eye Contact
Rinse immediately with tap water for 10 minutes – open
eyelids
forcibly
Skin Contact
Remove contaminated clothes, wash affected skin with water and
soap do not use any solvents
Inhalation
Remove the causality to fresh air and keep him/her calm in the
event of symptoms get medical treatment
Product Code: P22155
Version: 2
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Note to Physician
Treat symptomatically
Section 5 Fire and Hazard Data
Suitable Extinguishing Media
Water spray jet, dry powder, foam, carbon
dioxide Specific Hazards
Severe dust explosion hazard
Protection of Fire-Fighters
Precipitate gases/vapours/mists with water spray
Section 6 Accidental release measures.
Methods for Cleaning Up
Collect solids (avoid dust formation) and hand over to waste
removal, rinse with plenty of water
Section 7 Storage & Handling
Handling
Technical Measures
Processing in closed systems, if possible superposed by inert gas
(e.g nitrogen) local exhaust ventilation necessary, take
precautionary measures against electrostatic charging avoid dust
formation, high dust explosion hazard
Suitable Materials
Stainless steel, coated steel (protective lacquer), glass,
polyethylene, polypropylene, enamel
Unsuitable Materials
Aluminium, copper, zinc,iron etc
Storage
Storage Conditions
In closed containers, protect from humidity, at room
temperature Packing Materials
Tightly closed material like polyethylene
Section 8 Control Methods/Personal Protection
Engineering Measures
See Section 7
Threshold Value Air
None established
Analytics
Sampling in water and gravimetric or chemical determination
Product Code: P22155
Version: 2
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Section 8 Control Methods/Personal Protection - Continued
Personal Protective Equipment
Respiratory Protection
In case of high dust concentrations: particle mask or
respirator with independent air supply
Skin Protection
clothing
Wear protective gloves and clean body-covering
Eye Protection
Safety glasses
Section 9 Physical and Chemical Properties
Colour
Form
Odour
Section 10 Stability and Reactivity
White/Off White/Yellowish
Free Flowing Granular Powder
Almost odourless
Stability
humidity
Conditions to Avoid
Materials to Avoid
metal salts
Note
Stable at room temperature under exclusion of
Humidity
Oxidising agents, atmospheric oxygen, bases, metals,
On prolonged storage, a yellow discolouration may
occur through slow decomposition, which does not
noticeably diminish biological activity, however in
aqueous solutions ascorbic acid is very susceptible to
oxidative decomposition, particularly in the presence
of alkali resp. Heavy metal irons
Section 11 Toxicological Information
Acute Toxicity
LD50 11’900 mg/kg (oral, rat)
LD50 8’000 mg/kg (oral, mouse)
LD50 518 mg/kg (i.v.,mouse)
Local Effects
Eye: may cause mild irritations
Mucous membranes: may cause mild irritations
Skin: may cause mild irritations; particularly in
with humidity (perspiration)
conjunction
Product Code: P22155
Version: 2
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Chronic Toxicity
calculum
In predisposed individuals 4-12 g/d may cause urinary
Mutagenicity
Carcinogenicity
(several species)
Reproduction Toxicity
No suspicion of human mutagenicity
Not carcinogenic
Note
Oral uptake of up to 9g per day does not produce
any toxic
effects, however even lesser quantities may cause
diarrhoea. RDA (recommended daily allowance):
60mg
Not teratogenic, not embryo toxic
Section 12 Ecological Information
Inherent Biodegradability
Ecotoxicity
Air Polution
Well inherently biodegradable
97%, 5 d
100%, 15 d
(Zahn-Wellens test, OECD No. 302 B)
Barely toxic for fish (rainbow trout) LC50 (96h) 1020 mg/l (OECD
No. 203)
The inhibitory concentration relates to re-attachment to
substrate (Dreissena polymorpha), MIC (48h) > 50 mg/l (nominal
concentration)
Observe local/national regulations
Section 13 Disposal Considerations
Waste from residues
Observe local/national regulations regarding waste
disposal. Drain very small quantities into waste water
treatment plant. Large amounts incinerate in a qualified
installation with flue gas scrubbing
Section 14 Transport Information
Transport classification
Product Code: P22155
Not classified as dangerous for any mode of UK or
International transport.
Version: 2
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Section 15 Regulatory Information
European Regulation
regulations.
This product is not classified according to the EU
Reviews, Standards and Regulations
Health & Safety at work act 1974.
COSHH Regulations (1994).
EH40 Occupational exposure limits.
US Federal Regulations
Not known.
Section 16. Other Information
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.
Product Code: P22155
Version: 2
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Change History
Version
Change
1
2
First Issue
Iodine titration added as assay test method. Format updated
Customer Notification
required Yes / No
N/A
No
Document Approval
Task
Role
Name
Amended By
QC Technician
Kelsey Martin
11.08.2015
Approver
Quality Technician
M Lee
11.08.2015
Product Code: P22155
Version: 2
Sign
Date
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