Lipomed's Values
Since the synthesis of its first morphine glucuronides in 1993, Lipomed has
become a leading producer and supplier of high quality Drugs of Abuse
Reference Standards. Lipomed currently provides more than 190 different
native and/or deuterated reference substances intended for forensic
analysis, toxicology, pharmaceutical development, drug disposition research
and many other applications.
With the regular appearance of new designer drugs (e.g. 2C-I) and/or drugs
diverted from their therapeutic application (e.g. Tramadol), the need for
high quality and reliable reference standards is increasing. To meet this
demand, Lipomed's Research and Development department has established a
continuous development program for the synthesis of new reference
substances.
If you wish to be kept up-to-date with Lipomed's new Drug Reference
Standards, please visit www.lipomed.com. Lipomed's customers will also be
informed by email about new entries. In order to receive electronic product
information news free of charge please send an email to
lipomed@lipomed.com.
If the products you are looking for are not available from Lipomed's
existing product line, a custom synthesis service is offered. Please
complete the Custom Synthesis Request Form and send it to
Lipomed's Technical Service
Department. A
confidential and quick reply is guaranteed.
Commitment to Quality
At Lipomed quality is the corner-stone of all operations. Lipomed's quality
process ensures that all customers always receive reliable and accurate
products.
Lipomed's Drug Reference Standards are extensively documented to allow full
traceability at the synthesis and distribution levels. Quality starts with
the raw materials, whereby only materials with the highest purity are used
for synthesis.
Every selected compound is run through an extensive range of tests,
including elemental analysis, MS, NMR, IR, UV, optical rotation, melting
point, Karl Fisher water titration and other techniques as appropriate.
Lipomed's solid form standards are certified for purity, identity, and
additionally the quantity for the calibrated form. Lipomed's solution
standards are certified for purity, identity, and additionally the strength
for the calibrated form.
Lipomed's Drug Reference Standards will be supplied with lot-specific
certificates of analysis together with the defined specifications.
Calibrated and Non-Calibrated
Lipomed's Drug Reference Standards are available in two qualities:
calibrated and non-calibrated.
The calibrated quality refers to ready-to-use reference standards
(available in both solid and solution forms) intended for quantitative
purposes. Accurate weight and/or strength of calibrated reference standards
are based on the free drug substance.
Non-Calibrated Drug Reference Standards will be supplied as highly purified
bulk material. Weight and/or strength are based on the drug substance.
Solutions and Solids Available!
Lipomed's Drug Reference Standards are available in both solid and solution
form. We have done this to meet the specific needs of our customers, many
of whom prefer to leave the preparation of solutions to us. With Lipomed,
customers are able to choose the most appropriate form for their needs.
Standard solutions are supplied in 1 ml amber glass ampules.
Ready-to-use Solid Reference Standards
Lipomed's 1 mg vials contain high precision calibrated freeze-dried Drug
Reference Standards to an accuracy of 1.00 ± 0.05 mg of free drug substance
in 20 ml amber glass septum-capped vials.
Instructions for the Safe Use of Calibrated Solid Reference Standards
Calibrated standard solutions are prepared in an easy and safe way as
follows:
- Clip off the aluminium center of the cap.
- Add the solvent of choice through the septum using a gas tight
precision syringe. Gently shake and invert the vial several times to
ensure complete dissolution of the solid.
- Withdraw desired volume of calibrated solution through the septum
using a syringe.
Shelf life
Retest dates for all Lipomed's Drug Reference Standards are given on the
certificate of analysis, together with the corresponding batch numbers in
order to ensure full traceability.
Stability monitoring is performed on all Drug Reference Standards at
appropriate intervals.
Storage
Lipomed recommends airtight storage of their reference standards at a
temperature of 2-8°C and in a dark location unless otherwise indicated on
the label.
Use
Lipomed's Drug Reference Standards are specified for laboratory use only
and must not be used in humans.
Safety
All products mentioned in this catalogue have to be considered potentially
toxic substances and must be handled by suitably trained staff only.
Drug Testing Validation
In addition to the ready-to-use calibrated Drug Reference Standards,
Lipomed's drug substances are also available in bulk as 10, 50, and 100 mg
standard packs and by request in larger quantities.
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