| UNIBIOCHEM
fully conducts under ISO 9001: 2000 international quality management
system and controls the whole production process including purchase
of raw materials, production process and test of final products,
which guarantees the output of quality products. We have established
a complete standard operation procedure (SOP) and we also operate
and manage according to the SOP strictly. High quality and high
efficiency commercial manufacture ability, special regular job
training and standard strict quality control system give the
products efficiency guarantee. |
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| The
quality target of UNIBIOCHEM is to provide high quality products
to satisfy or exceed the customers' quality expectation. We
offer products that are non-animal/human origin and offer an
origin certificate as part of an order. The strict evaluating
procedure guarantees and controls the origin of raw materials.
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| Quality
of product is closely inspected through multiple steps starting
from raw material control, it includes but not limited to: material
test and release, master batch sheet approval, executing batch
sheet approval, batch sheet implementation monitoring, QC in
process control and intermediate test, batch sheet review, product
release, pre-shipment inspection and sample delivery, shipment
tracking. |
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| We
believe that quality of product is not obtained from test, it's
built into product in each step of supply chain such as product
process design, manufacturing, sales etc. by numerous quality
assurance activities. Quality Systems Approach to Pharmaceutical
Current Good Manufacturing Practice Regulations. |
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| We
also use the following analysis methods and apparatus for product
testing: |
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·
Enantiomer Content
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Electrospray Mass Spectroscopy (ESI-MS Iontrap, Quadrupol &
TOF) |
| ·
Elemental Analysis (CHN) |
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Endotoxins (LAL-test) |
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Gas Chromatography (GC) |
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Heavy Metals |
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High Performance Liquid Chromatography (HPLC) |
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High Performance Liquid Chromatography coupled with Mass Spectroscopy
(HPLC-MS) |
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Infrared Spectroscopy (IR) |
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Ion Chromatography (IC) |
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Loss on Drying |
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Melting Point |
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Nuclear Magnetic Resonance Spectroscopy (NMR) |
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Residue on Ignition |
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Solubility |
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Specific Rotation |
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Sulfated Ash |
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Thin Layer Chromatography (TLC) |
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Titration |
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Total Organic Carbon (TOC) |
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Total Viable Aerobic Counts |
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UV/VIS Spectroscopy |
| ·
Water Content |
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UNIBIOCHEM
