Brought to you by the International Journal of Pharmaceutical Compounding
April 27, 2007 Volume 4, Issue 17
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: Quality Assurance in Compounding, Part VI

United States Pharmacopeia (USP) Chapter <741> Melting Range or Temperature

Over the past couple of years, several compounding pharmacists have inquired about the use of a melting point apparatus to confirm the melting points of incoming compounding materials; basically, a double-check for comparison against the Certificate of Analysis.

USP Chapter <741> Melting Range or Temperature is the chapter covering this topic. It defines the melting range or temperature of a solid as those points of temperature where the solid coalesces and is completely melted, unless defined otherwise for Class II and III drugs. Any apparatus or method capable of equal accuracy can be used, and the accuracy of the apparatus should be checked at suitable intervals using one or more of the six USP Melting Point Reference standards, preferably those that melt nearest the melting points of the substances being tested. It should be noted that most drugs have melting points less than 300�C with most of them less than about 250�C.

A very general procedure is as follows (more detail is provided in the USP):

  1. Comminute the test material to a very fine powder.
  2. If a hydrate, render it anhydrous (this can be done by placing a dehydrating material (Indicating Drierite) in a sealable container and setting the container of the test material (open) into the sealable container, sealing the larger container and letting it set overnight.
  3. Depending upon the device used, place the required quantity of dried, fine powder on the sample holder.
  4. Follow the instructions of the manufacturer of the melting point apparatus being used.
  5. Document the results obtained.

The temperature at which the substance is observed to collapse definitely at any point is defined as the beginning of melting. The temperature at which the substance becomes liquid throughout is defined as the end of melting or the "melting point." Both temperatures should fall within the limits of the melting range required for that substance.

There are many types of apparatus that can be used, and this is a relatively simple and straightforward method after one becomes experienced in its use.


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

 
Compounding Pharmacy Survey

USP is conducting a survey regarding compounded medications used in pediatric and geriatric patients to determine the most frequently compounded medications and how often these medications are requested. USP is interested in providing quality standards for compounded medications in order to assist those practitioners who provide this service to patients, and to ensure that the medications compounded are safe for patients and consumers.

Every respondent, who completes the survey and provides their name, address, and e-mail, will receive a $5.00 gift certificate to Starbucks. As a further incentive, the first 10 respondents will receive a free USP Pharmacists' Pharmacopeia (a $225.00 value). For more information see http://www.usp.org/hqi/pharmInfo/compoundingPharmSurvey.html

 
Regulatory Information

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists (IACP). For more information, www.iacprx.org.

Senator Pat Roberts Clarifies his Position on SDCA
and
Dr. Allen Testifies on Behalf of Compounding Pharmacists

Read more about these items at http://iacprx.convio.net/site/MessageViewer?em_id=2982.0

 
Compounding Tip of the Week

Stay Informed!
If you are not already active on the Compounders' Network List (CNL), you might consider joining in as the political activities are warming up. New legislation being discussed in Congress will affect ALL pharmacists, not just compounding pharmacists. The CNL is the most efficient way of discussing and keeping up with what is going on and is an excellent way of getting your views heard on these topics. Also, it is vitally important to consider attending "Compounder's on Capitol Hill", sponsored by IACP, this summer. If you have never attended, it is something you will long remember; being a part of our political process. You will see the good, the bad, and the �! But, it is an open process, and it is up to us to participate; after all, we have the freedom to do so!

Join the CNL by going to either www.ijpc.com or www.CompoundingToday.com and click on the Compounders' Network and follow the instructions.

RxTriad
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