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Oatmeal - plant - Avena sativa
Whey Protein concentrate - cow milk- animal - cow
Soy flour - plant - Glycine max NON GMO
Vitamin Mix
Maltodextrin
Sodium chloride
Calcium carbonate
(precipitated)
synthetic
flow chart
synthetic, mineral
flow chart
L-Choline bitartrate
Magnesium chloride *
6H2O
synthetic
flow chart
synthetic
plant (Maize, Sugar Beet),
mineral
origin, composition
synthetic
vegtable (corn) =>
fermentation
flow chart
Potassium citrate
Magnesium oxide (heavy)
Vitamin C (ascorbic acid)
Vitamin E 50% (dl-alphatocopheryl acetate, 500 IU)
flow chart
Potassium iodate
synthetic
n.a.
Niacin (niacinamide)
Vitamin A (retinol acetate)
325000 IU
synthetic
vegetable( beet sugar,
maize, acacia), synthetic)
synthetic,
vegetable(maize, sugar
cane, coconut),
animal wool grease (fat)
flow chart
synthetic
flow chart
Folic acid
petrochemical
flow chart
Chromium chloride
synthetic
n.a.
Biotin
Vitamin B12
(cyanocobalamin)
synthetic
flow chart
flow chart
Vitamin K1 5%
fermentation
synthetic,
vegetable(maize, acacia)
Vitamin B2 (riboflavin)
Copper sulphate
Vitamin B6 (pyridoxine
hydrochloride)
synthetic
Vitamin D3
Pantothenic acid (calciumD-pantothenate)
synthetic
flow chart
flow chart
flow chart
flow chart
ffi4ffi W
&dgffifu.w
Dissolving
lnsolubles
(Clay, anhydrite,
magnesium hydroxide)
Sedimentation
Evaporation I Crystallisation
Packaging
25 I 50 ks PE baqs,
{--
Vitamin D3 100 SD
Preparation of Matrix
(water soluble
components in water)
Preparation of
Oil Phase
Emulsification (Highpressure)
Pressure control
Holding
Spray Drying
Sifting
Packaging
Temperature control
Screen size
Nutraceuticals
Herstellungsmethode (Calciumcarbonat, schwer, Magnesia 449):
Calcit
Zerkleinern
Trocknen
Siebung
Mahlen
Analysieren, CaCO3
Verpacken
Comments on the production process:
Only natural Calcium carbonate (CaCO3) from 5 m to 4 6 mm is micronized. Raw material in
stones of 10 cm arrives in the main plant from the quarry, 8 km far, and here it starts to be
micronized. Micronization takes place in two different lines: technical line and pure line. In the
technical line all products for technical market are obtained, while in the pure line only products for
both food and pharmaceutical market are manufactured. Both lines are completely closed and
separated and no contaminations are possible.
Thanks to the dry and friable raw material, during the process no liquids or chemicals are used and
only compressed air is used for cleaning machinery.
In the process there are three metal detectors. They are able to detect only ferrous materials,
whereas for the pure line a glass procedure is in place.
The plant works for 24 hours per day, 7 days per week. Maintenance is done during summer time
and winter holidays when machinery is off.
Controls of critical steps:
Raw material:
In-process-controls:
Finished product:
chemical analysis
periodically throughout the manufacturing process; physical analysis
and insoluble matter in acetic acid
chemical and physical analysis
71805
Fermentation
Continuous lysis
Membrane filtration
Adsorption in column
Storage in
warehouse
Dibenzyl biotin/
Hydrobromic acid
Checking
materials
Water/
Methylbenzene
Debenzylation
Dropping liquid
caustic/Keeping PH
Storage in
Plant
Receiving by
Plant
Thermal
insulation
Recovering
hydrobromic acid
Extracting/
Demixing
Checking
equipments
Liquid caustic
HB/Methylbenzene
solution
Extraction
Adjust pH in
aqueous layer
Filtration
Crystallization/
Centrifugalization
Water/ Activated
carbon/EDTA
Biotin crude
Refluxing/
Filtration
Drying
Milling
CCP1
Packaging
Storage in
Plant
Sampling
CCP2
Test by QC
Release by
QA
Storage in
warehouse
Transport to
customer
1/1
neutralization
crystallization
centrifugation
drying
sieving
NO2
packaging
p-nitrobenzoyl chloride
Alkali liquor
Water
Monosodium glutamate
Condensation
Stand to delamination
Version 05.11, supersedes 04.07
-1/1-
TPC_G10_EN
Iron powder
Adjusting
Recollect
Reduction
Distillation
Ammonium chloride
Toluene
Temperature Preservation
Filter
Decolorization
Filter
Salt formation
Human Nutrition
Flow Chart:
Dry Vitamin A-Acetate 325 GFP/E
Powdering agent
Atomization
Air
Drying
Air
February 2012
For information only not for regulatory purposes no update service - August 2005
Manufacturing site:
CONFIDENTIAL
Process Chart of
Pyridoxine Hydrochloride
Starting materials: 4-methyl-5-ethoxyoxazole, n-propyl dioxepin
Flow chart:
Ethanol
4-Methyl-5-ethoxyoxazole
Addition reaction
Aromatization
n-Propyl dioxepin
Drying
Milling/Sieving
Purification
Hydrolysis
Finished product
Remark: CCP is the Milling process. Inside the milling machine there is a screen. The
integrity of the screen and the remains of material on the screen are inspected and recorded
for each batch production.
Human Nutrition
Flow Chart:
Calcium D-Pantothenate
Manufacturing site: Ludwigshafen, Germany
P.C.: 333300
Fax: +86-798-6702928
Website: http://www.txpharm.com
Calcium -alaninate
D-pantolactone
Page 1 of 2
Methanol
Crystallisation
Water
Spray drying
Calcium D-pantothenate
For information only not for regulatory purposes no update service - January 2005
Version 1, 03.2011
Emulsion of Vitamin K1
Powdering agent
Atomization
Air
Drying
Air
Sieving
This document, or any answers or information provided herein by BASF, does not constitute a legally binding obligation of BASF.
While the descriptions, designs, data and information contained herein are presented in good faith and believed to be accurate, it is
provided for your information only and not to be used for purposes of pharmaceutical registrations.
There is no automatic update service for this information.
SELLER MAKES NO WARRANTY OF ANY KIND; EITHER EXPRESS OR IMPLIED, BY FACT OR LAW, INCLUDING
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE.
METHOD OF MANUFACTURE
Magnesium Oxide, heavy
Magnesium Oxide
Demin. Water
Suspension
Purification
Drying
Packing
The raw materials are ordered by the Dr. Paul Lohmann GmbH KG according
to internal specifications or pharmacopoeia, controlled by Quality Control and
released for production thereafter.
Only Demineralised Water is used as a cleansing agent and solvent.
The final product is analysed by QC according to methods of specification or
pharmacopoeia.
If all tests comply with the limits, the material is released for shipment.
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