Cdex, Inc. (fka CDEX)

[capnmike]

Crow3, more on your misinformed belief and assumptions regarding shelf life, compounded pharmaceutical stability, beyond use dating, etc etc...

Shelf-Life of the Substance Cisplatin
http://www.inchem.org/documents/pims/pharm/cisplat.htm

pharmacy compounded parenteral and shelf life
http://books.google.com/books?id=vI3DtcTA2RkC&pg=PR2-IA32&lpg=PR2-IA32&dq=parenteral+shelf+life+compounded&source=bl&ots=7-h3sGhNlf&sig=VdJ6Y2ZOiF1sIIm0jscqxlK6FoU&hl=en&sa=X&ei=xLdVUrDGJ4T48gTQ6YCIBw&ved=0CDEQ6AEwAQ#v=onepage&q=parenteral%20shelf%20life%20compounded&f=false

Stability of a pharmaceutical product
is defined by USP-NF as the “extent to
which a product retains, within specified
limits and throughout its period of
storage and its use (i.e., its shelf life),

Determination of beyond-use
dating for compounded preparations
can be challenging and is based on stability
studies when such data are available

http://www.cedrugstorenews.com/userapp//lessons/page_view_ui.cfm?lessonuid=&pageid=98A4D0865060D9CDE96A50282801AE4D

Concerns regarding stability had led the pharmacy staff to prepare three syringes each of succinylcholine (10 mL of 20 mg/mL) and ePHEDrine (10 mL of 5 mg/mL) every other day to stock in the labor and delivery anesthesia cart. The succinylcholine was drawn into a 10 mL syringe directly from the 10 mL vial. For ePHEDrine, normal saline was used to first dilute the 50 mg/mL, 1 mL ampul to a final concentration of 5 mg/mL. However, each 10 mL dose was prepared in a 20 mL syringe to help differentiate the two drugs.

http://www.ismp.org/newsletters/acutecare/articles/20110602.asp

Many others are available to you on the Web...

regulatory requirement for distinct specifications for release and for shelf-life where different. ...... c) Sterility: All parenteral products should have a test procedure and acceptance criterion .... (Example: Compound A has as its lowest solubility at.
..................
Stability and degradation kinetics of etoposide-loaded parenteral lipid emulsion. ... The shelf life (T(90%)) of etoposide in lipid emulsion was estimated to be 47 days ...
......................
... be large enough to maintain the product pH for a reasonably long shelf-life. ... On the other hand, the buffer capacity of ophthalmic and parenteral products ...
........................

CDEX Ships ValiMed G4 Medication Validation System

Prominent Global Medical Technology Company to Use for Research and Development

the first ValiMed™ G4 drug validation system to a prominent US based global medical technology company. The company intends using the ValiMed G4 as a lab instrument for a research and development project to determine the shelf life of parenteral admixtures with regards to potency over time.

http://finance.yahoo.com/news/CDEX-Ships-ValiMed-G4-iw-3043086989.html

The ValiMed G4 allows them to retain product sterility by performing analysis through the container.

The ValiMed G4 uses Raman Spectroscopy data, plus Fluorescence Spectroscopy data, plus Reflective data in a simultaneous and unique manner to obtain an optical signature, and uses those same processes to capture the optical signature of a target of interest (say, a parenteral admixture, a drug in a vial, an irrigation solution in a bottle or FDA approved bag, etc etc, and provides the user with drug ID as well as concentration.

The global medical technology company that got the first ValiMed G4 was apparently happy with the drug signatures available and are using it to do just what has been published...determine the shelf life of parenteral admixtures with regards to potency over time.

To see what the ValiMed G4 system is designed to do, check the patent app

http://appft.uspto.gov/netahtml/PTO/search-bool.html

United States Patent Application 20130120741
Kind Code A1
POTEET; Wade M. ; et al. May 16, 2013

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CHEMICAL AND MOLECULAR IDENTIFICATION AND QUANTIFICATION SYSTEM UTILIZING ENHANCED PHOTOEMISSION SPECTROSCOPY


Abstract

An enhanced photoemission spectroscopy (EPS) system uses at least three photoelectric detection processes to identify a substance or substances in a target. The target can be in a container, and the EPS system accounts for this in the identification process. The photoelectric detection processes include Raman scattering, fluorescence and spectral reflection. The EPS system uses all three processes to generate spectral data that is then combined to derive a target signature. The target signature is then compared to stored signature data to determine the substance or substances in the target.

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Inventors: POTEET; Wade M.; (Vail, AZ) ; STARZINGER; Carey W.; (Benson, AZ) ; BRUMFIELD; Jeffery K.; (Romona, CA)


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CDEX, INC