Product name
|
Tribulus 2500 tablet
|
Code
|
2013/05.A.00002
|
Edition
|
1
|
Approval date
|
02-12-2016
|
Physical requirements
|
Appearance
|
Red, oblong, biconvex coated tablets
|
Weight
|
1800 mg
|
|
Packaging
|
Packaging
|
120 tablets
|
Bottle volume
|
300 ml
|
Bottle material
|
PET
|
Label size
|
|
Others
|
lid & seal
|
|
Nutritional Facts
|
Supplement Facts
|
Serving Size: Two red, oblong tablets
|
Servings Per Container: 60
|
Amount Per Serving (2 tabs)
|
|
% Daily Value*
|
Tribulus Terrestris extract (100% fruit)
(Standardized to 87% (+/-5%) saponins)
|
2500 mg
|
ƚ
|
* Percent Daily Values are based on a 2000 calorie diet.
ƚ Daily Value not estabilshed.
|
Other Ingredients: Tribulus Terrestris extract (100% fruit; Standardized to 87% (+/-5%) saponins), bulking agents (microcrystalline cellulose, hydroxypropyl methyl cellulose), glazing agent (hydroxypropyl methyl cellulose), anti-caking agents (magnesium stearate, silicon dioxide), colors (titanium dioxide; Ponceau 4R*). *May have an adverse effect on activity and attention in children.
|
|
Expiration
|
The Vitalab product called Tribulus Terrestris 2500 tablet has a shelf life of 3 years from date of manufacture.
|
Storage
Requirements
|
Store in tightly closed container, at 15 - 25°C. Protect from light and humidity.
|
Certificate of Origin
|
Made in EU.
|
Distinctive signs
|
Production date, LOT number
|
Manufacturing process
|
Raw materials are to be put under quality check based on their unique registration number.
- Formula raw materials are to be weight out in closed system.
- After weighing, raw materials are to be homogenized, instantized and drizzled.
- Raw materials are to be mixed homogeneous according to strict regulation by industrial air mixing homogenizer.
- A wet granulate is prepared by adding the liquid binder–adhesive to the powder blend and mixing thoroughly.
- The damp mass is passed through a mesh to form pellets or granules.
- The granulation is dried.
- Tablets are formed from the granulation.
- Tablets get coating.
- The ready product is to be checked by its flavor, composition, consistence, color.
- The product goes to the packaging section of the factory in a sterile and closed gravity system.
- According to appearance, it is to be filled in sack, box or pack by the automatic filling system.
- Product labels, caps, sleeves are to be affixed on the product by the automatic system, induction closing as well as production number (which accompanies the whole production documentation) and expiry date are to be put on.
- Products are to be put in carton boxes and carton labels are to be affixed.
Samples are to be taken from each production number during production and they are to be retained until the end of expiry. Product sampling is to be carried out in different production phrases and their qualities are to be checked.
|
Chemical Requirements
|
|
Minimum
|
Test
|
Method
|
per serving
|
Frequency
|
AOAC 14 ed.
|
Calories
|
8,45 kJ/2,1 kcal
|
audit
|
by calculation
|
Protein
|
0 g
|
per lot
|
AOAC 2.057
|
Carbohydrates
|
0 g
|
audit
|
by calculation
|
Fat
|
0 g
|
audit
|
AOAC 16.219
|
Dietary Fibre
|
1,056 g
|
audit
|
AOAC 67.6
|
Polyol
|
0 g
|
audit
|
HPLC
|
Organic acid
|
1 g
|
audit
|
AOAC 986.13
|
Moisture
|
< 3%
|
audit
|
AOAC 16.212
|
Ash
|
< 4%
|
audit
|
AOAC 16.216
|
|