Pharmacopeial Forum

A <83 ? B+ <;;'@ HARMONIZATION 1699

MONOGRAPHS (USP) Add the following:

Alcohol
BRIEFING
Alcohol, USP 26  38   <3;9  PF <9' ?: B ,<%7+ (7;9
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TION Stage 6 
       

 


  

   
    

  
   
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 Identi®cation 
( Identi®cationÐ  A  B     #

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    "  ! 

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3 Clarity of solutionÐ
     
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7 Color of solutionÐ
     
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9 Speci®c gravityÐ/ 
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= AcidityÐ
         Acidity or alkalinity
 
 #
   
8 Limit of nonvolatile residueÐ
 
    
USP Reference standards h66iÐUSP Alcohol RS.

(;  6;;
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6; Water-insoluble substancesÐ
    5  
 Clarity of solutionÐ?/+ C
 Test solution   


    Nonvolatile residue  Volatile 
  Reference suspension A   #   
impurities, 
     
66 Aldehydes and other foreign organic substancesÐ
     
 3
      Reference sus-
   #
Volatile impurities 
6< Amyl alcohol and nonvolatile, carbonizable substancesÐ pension A.@

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Volatile impurities 
6' Ultraviolet absorbanceÐ
     
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 Hydrazine solutionÐ   6;  
   
  
6( Limit of acetone and isopropyl alcoholÐ
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 D $ !    #

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Volatile impurities 
63 MethanolÐ
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Volatile impurities  #   !
 
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# 2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
 Pharmacopeial Forum
1700 HARMONIZATION A <83 ? B+ <;;'@

Primary opalescent suspensionÐ?/+ C
    Test solution B 
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  Reference suspension A.

  
   
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 Methenamine Standard stock solutionÐ,
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solution  
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Opalescence standardÐ?/+ C
   
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Reference suspensionsÐ   3;
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 solution  #     

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Test solution BÐ 6;  <;

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ProcedureÐ   "   Test solution  $  Visual Comparison  Spectrophoto-
A  Test solution B         metry and Light-Scattering h=36i
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Speci®c gravity h=(6i: # ;=6<  ;=67  63378
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Acidity or alkalinityÐ
erence suspension A      
 

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Reference suspension A.@ Test solution A
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# 2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
Pharmacopeial Forum
A <83 ? B+ <;;'@ HARMONIZATION 1701

ProcedureÐ  <;
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 solution A  Test solution B  
 


 

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Test solution BÐ- 63; m.  (

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# 2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
 Pharmacopeial Forum
1702 HARMONIZATION A <83 ? B+ <;;'@

solution D: 
 
 <
 *   
  66 Aldehydes and other foreign organic substancesÐ
  
   #
Volatile impurities 
     "
  
   

6< Amyl alcohol and nonvolatile, carbonizable substancesÐ

      #
Volatile impurities 

 
  
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   6' Ultraviolet absorbanceÐ
   
! 
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 6( Limit of acetone and isopropyl alcoholÐ
     
#
Volatile impurities 
  #
Test solution B: 
 
 
   
 63 MethanolÐ
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Volatile impurities 
67 Volatile impuritiesÐ
 


    
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Test solution B 8
 Add the following:
Limit of nonvolatile residueÐ!   6;;
.    Dehydrated Alcohol

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    6;;8  6;38  6
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 ?64-17-5@
BRIEFING
Dehydrated Alcohol, USP 26  7;
    

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883   !
  63378  ,<%3+%
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 ADOPTION Stage 6

       

 

   


   
    

      

Packaging and storageC!  
   
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 &   3-  35       

 
 
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    # 
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TION Stage 6 
  
  USP

 USP Reference standards h66iCUSP Dehydrated Alcohol

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6 "C/ 
 RS
< Packaging and storageÐ     


  
' USP Reference standardsÐ-      -
 Clarity of solutionÐ?/+ CTest
solution    

   
 Identi®cation 

( Identi®cationÐ  -  5     #

 "   Reference suspension A   #   
! Infrared absorption   
   Speci®c gravity

!  Identi®cation  
 3
      Reference suspen-
3 Clarity of solutionÐ
     
 #

   sion A.@
7 Color of solutionÐ
     
 #
  
  Hydrazine solutionÐ   6;  
   
9 Speci®c gravityÐ/ 

= AcidityÐ
         Acidity or alkalinity  6;;
. !
 D $ !  #   #

 
 #
   
8 Limit of nonvolatile residueC
 
     #   !
 
& -#     (  7


(;  6;;
.
noitazinomraH

6; Water-insoluble substancesÐ
    5  



    Nonvolatile residue  Volatile
impurities, 
     

# 2003 The United States Pharmacopeial Convention, Inc. All Rights Reserved.