MedicineLakex

Raw material specification template

PRODUCT TECHNICAL DOSSIER
TRIBULUS TERRESTRIS EXTRACT 95% SAPONINS

Product Code:
P20046
Raw Material Full Name:
Tribulus Terrestris Extract 95% Saponins
Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms:
Tribulus Terrestris L
This material is Food Grade
Assay (by UV):
Min 95.0% Saponins
Ratio of Material:
Approx. 10:1
Solubility in Water:
40-50% Soluble in Water
Solubility in Alcohol:
The Solubility of this product in 75-80% Alcohol 80%
Particle Size:
100% pass through 80 Mesh
Bulk Density:
40g/ml – 60g/ml
Loss on Drying:
Max 5%
Ash:
Max 5.0%
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1

Country of Origin:
China
Country of Origin of the Manufacture:
China
Base Source/Start Material:
Fruits of the Tribulus Terrestris L
Origin of Product – Synthetic, Plant, Mineral, Animal, Fish or Fermented:
Plant
What is the extraction/processing used? What solvents are used and at what ratio's?
Physical extraction by 75% ethanol and water
Compound Ingredients:
Max 5% Dextrin sourced from corn
Shelf Life from Date of Manufacture:
2 Years
Storage Conditions:
Store in a well-closed container away from moisture and direct sunlight.
Appearance:
Fine Powder
Colour:
Brown/Yellow
Flavour/Taste:
Characteristic
Texture:
Powder
Odour:
Characteristic
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1

Microbiological Test
Total Viable Count:
Max 100,000cfu/g
Yeast & Moulds:
Max 10,000cfu/g
E.Coli:
Negative
Salmonella:
Negative
Staphylococcus:
Negative
Metals
Heavy Metals:
Max 20ppm
Lead (Pb):
Max 3ppm
Arsenic (As):
Max 2ppm
Pharmacopeia Standard Used:
CP
There are no nuts in this recipe and are no nuts on site, however we cannot guarantee that the raw
materials entering the site are nut free.
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1

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 Colours (Artificial / Nature Identical / Natural / Smoked) Free from Dextrose Free from Dioxins Free from Ethanol Used in Extraction
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1

INTOLERANCE DATA
If No please give
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 Lactose Free from MSG (Added and Naturally Occurring E621) Free from Nucleotides (E627, E630, E631, E635) Free from Polyols Free from Preservatives Contains Dextrin in
Free from Starch Products (Including Maltodextrin) the product
Free from Sorbic Acid (E200, E203) 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 Not Certified
Not Certified
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1 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. Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1 PRODUCT PROCESS FLOW DIAGRAM The Material of Tribulus Terrestris Extraction Solution Filter and Concentrate Concentrated Solution Alcohol Sediment Keep Out Impurities Finished Product Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1 MATERIAL SAFETY DATA SHEET

Section 1 Description

PRODUCT NAME:
TRIBULUS TERRESTRIS EXTRACT 95%

PRODUCT CODE:
Cambridge Commodities Limited 78 Lancaster Way, Ely, Cambridgeshire, CB6 3NW. Tel: 01353 667258. Email: [email protected]
Section 2 Ingredients/Identity Information

Components
Tribulus Terrestris
Section 3 Possible Hazards

Potential Acute Health Effects: Slightly hazardous in case of skin contact (irritant) of eye contact (irritant) of
ingestion, of inhalation.
Potential Chronic Health Effects:
CARCINOGENIC EFFECTS: Not available
MUTAGENIC EFFECTS: Not available
TERTOGENIC EFFECTS: Not available
DEVELOPMENTAL EFFECTS: Not available
Repeated or prolonged exposure is not known to aggravate medical condition

Section 4 Emergency and First Aid Procedures

Eye Contact: Check for and remove any contact lenses. In case of contact immediately flush eyes with plenty of
water for at least 15 minutes. Seek medical attention
Skin Contact: Wash with soap and water, cover the irritated skin with an emollient. Seek medical attention if
irritation develops.
Inhalation: If inhaled remove to fresh air. If not breathing give artificial respiration. If breathing is difficult give
oxygen, get medical attention
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1 Section 4 Continued

Ingestion: Do NOT induce vomiting unless directed to do so by medical personal, never give anything by mouth
to an unconscious person. If large quantities of this material are swallowed seek medical assistance immediately,
loosen tight clothing such as collar, tie, belt or waistband.
Section 5 Fire and Hazard Data

Flammability: May be combustible at high temperature.
Auto-Ignition Temperature: Not available
Flash Point: Not available
Fire Hazards in Presence of Various Substances: Slightly flammable to flammable in presence of heat. Non-
flammable in presence of shocks.
Explosion Hazards in Presence of Various Substances: Risk of explosions of the product in presence of
mechanical impact: not available. Risks of explosion of the product in presence of static discharge: not available
Fire Fighting Media and Instructions: SMALL FIRE: Use dry chemical powder. LARGE FIRE: Use water
spray, fog or foam. Do not use water jet.
Special Remarks on Explosion Hazards: Organic dusts can form explosive mixtures in the air.
Section 6 Accidental release measures.

Small Spill: Use appropriate tools to put the spilled in a convenient waste disposal container. Finish cleaning by
spreading water on the contaminated surface and dispose of according to local and regional authority requirements
Large Spill: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by
Spreading water on the contaminated surface and allow to evacuate through the sanitary system.
Section 7 Precautions for Safe Handling and Storage

Precautions: Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk,
evaporate the residue under a fume hood. Ground all equipment containing the material. Do not breath dust.
Storage: Keep container tightly closed. Keep container in a cool well-ventilated area. Do not store above 24oC
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1 Section 8 Control Methods/Personal Protection

Engineering Measures
Provide sufficient mechanical (general and/or local exhaust) ventilation. Respiratory Protection Avoid inhalation. 3M Dust respirator No. 8710 or 9900 is recommended, or a NIOSH/MSHA jointly approved dust respirator Hand/Body Protection Avoid contact and prolonged or repeated exposure. Wear resistant gloves such as rubber. Wash thoroughly after handling. Protective clothing recommended. Safety glasses in compliance with OSHA regulations are recommended.
Section 9 Physical and Chemical Properties

Physical state

Section 10 Stability and Reactivity

Stability: The product is stable
Instability Temperature: Not available
Conditions of Instability: High temperature, dust generation
Corrosivity: Not available
Section 11 Toxicological Information

Route of Entry: Inhalation, Ingestion.
Toxicity to Animals: LD50: Not available. LC50: Not available.
Chronic Effects on Humans: Not available
Other Toxic Effects on Humans: slightly hazardous in case of skin contact (irritant) of ingestion of inhalation.
Special Remarks on Other Toxic Effects on Humans:
Acute Potential Health Effects:
Skin: Unlikely to cause skin irritation or injury
Eyes: Dust can cause eye irritation
Inhalation: This material may produce dust may cause respiratory tract irritation. Breathing small amounts of this
material during normal handling is not likely to be harmful. Ingestion: Swallowing small amounts of this material
during normal handling is not likely to be harmful. The toxicological properties of this substance have not been
fully investigated.
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1 Section 12 Ecological Information

Eco-toxicity: Not available
BOD5 & COD: Not available
Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However long
term degradation products may arise
Toxicity of The Products of Biodegradation: Not available
Section 13 Disposal Considerations

Waste must be disposed of in accordance with 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
This product is not classified according to the EU regulations. Reviews, Standards and Regulations Health & Safety at work act 1974. COSHH Regulations (1994). EH40 Occupational exposure limits.
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.
We confirm that the information above is sourced from the original manufacturers/suppliers
Specification.
To be used as per local legislation.
Version No: 1
Compiled and Authorised By: S. Frankish Issue Date: 14.02.12. Version No: 1

Source: http://www.c-c-l.com/ugc-1/pdfs/spec-20046.pdf