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Diagnostics - About our Drug Reference Standards

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:

  1. Clip off the aluminium center of the cap.
  2. 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.
  3. 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.