DEC Submission Form

 
DEC Information | CPDD | Annual Reports
Please print out this form and submit to Andy Coop at the address below before 2/28/07.  Compounds will not be accepted after this date.

DATA SHEET FOR COMPOUNDS SUBMITTED FOR BIOLOGICAL EVALUATION UNDER THE
AUSPICES OF THE DRUG EVALUATION COMMITTEE (DEC, CPDD)
NIH or CPDD #                                                     DATE RECEIVED (ACKN.):
----------------------------------------------------------------------------------------------------------------------------------------------
NOTE TO SUBMITTERS
:
Samples submitted for evaluation of their physical dependence potential
and abuse liability, under the auspices of the DEC, should be accompanied by validation of identify
and purity (e.g., for identification: nmr spectrum, for purity: thin layer chromatography (TLC; 2.5 x
10 cm, or 5 x 20 cm plates). Please state the experimental conditions for spectroscopic
identification and, for TLC: 1) Type of TLC plate (e.g., Analtech Silica Gel GF), 2) Solvent system
used - (e.g., CHCl
3:MeOH:NH4OH - 90:9:1), 3) Detecting agent - (e.g., iodine vapor, UV light), 4) Rf
of the compound, run with a comparison standard drug (e.g., codeine, diazepam, PCP), if possible.

_________________________________________________________________________________
DEC POLICY ON RELEASE OF DATA
LIMITS OF CONFIDENTIALITY OF DATA
:
Data obtained under the auspices of the DEC will be held
confidential until three years elapse from the time of receipt of the sample unless: (1) you give us explicit permission to
 publish such data sooner; or, (2) in the rare and unlikely event that a department, agency or instrumentality of the U.S.
 Government or the World Health Organization requests information on a specific compound in the interest of the public
 welfare (e.g., a scheduling decision). Should such a request be made, you will be notified. When any of these
 conditions pertain, the data obtained under the auspices of the DEC and the molecular structure of the compound will be
 released. Information published will not include the source of the compound, the name of the submitter, nor any
 biological data sent to the DEC by the submitter.
_______________________________________________________________________
SUBMITTER - PLEASE SUPPLY THE FOLLOWING INFORMATION

CHEMICAL NAME:

COMMON NAME:

SUBMITTER:                                                      DATE SUBMITTED:

FORMER CODE#:                                              AMOUNT SUBMITTED:
_____________________________________________________________________

MOLECULAR STRUCTURE:

 

MOLEC. FORMULA:

MOLEC. WEIGHT:

% OF ACTIVE DRUG:           IMPURITIES:              PHYSICAL STATE (SOLID, OIL):

HYGROSCOPIC: YES: ____ NO: ____               POSSIBLE TOXICITY:
_____________________________________________________________________

SOLUBILITY - PLEASE CHECK APPROPRIATE BOX:    STABILITY

(IF VERY SOLUBLE IN WATER, NO OTHER

 

(PLEASE CHECK)

SOLUBILITY DATA ARE NEEDED)

STABLE

UNSTABLE

1=>20 mg/ml; 2=10-19 mg/ml; 3=5-9 mg/ml;

 

1) HEAT

   

4=1-5 mg/ml; 5=insoluble in water

 

2) LIGHT

   
 

1

2

3

4

5

 

3) AIR

   

1) WATER

           

4) ACID

   

2) DILUTE HCl

           

5) BASE

   

3) OTHER SOLVENT:

MAXIMUM RECOMMENDED TEMPERATURE FOR 24 HOUR STABILITY IN WATER (IF SOLUBLE):
SEND SAMPLES TO:
Dr. Andy Coop; Biological Coordinator, Drug Evaluation Committee, CPDD; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 20 Penn Street, Rm 637, Baltimore, MD 21201. (Telephone: 410-706-2029; FAX: 410-706-5017; E-mail: acoop@rx.umaryland.edu).

 

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This page was last updated on: 01/27/07