Monographs

Updated June 27, 2013

Excipients

E-01 Alcohol
l USP Title: Alcohol
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2, correction 1

E-02 Dehydrated Alcohol, Rev 2
USP Title: Dehydrated Alcohol
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2

E-03 Benzyl Alcohol
USP Title: Benzyl Alcohol
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2, Correction 1

E-04 Calcium Disodium Edetate
USP Title: Edetate Calcium Disodium
USP Expert Committee (2010–2015): Monographs—Small Molecules 3
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: First

E-05 Calcium Phosphate Dibasic
USP Title: Dibasic Calcium Phosphate Dihydrate
USP Expert Committee (2010–2015): Monographs—Dietary Supplements
USP Scientific Liaison: Huy Dinh
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 1

E-06 Calcium Phosphate Dibasic Anhydrous
USP Title: Anydrous Dibasic Calcium Phosphate
USP Expert Committee (2010–2015): Monographs—Dietary Supplements
USP Scientific Liaison: Huy Dinh
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 1

E-07 Carmellose Calcium
USP Title: Carboxymethylcellulose Calcium
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-08 Carmellose Sodium
USP Title: Carboxymethylcellulose Sodium
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: N/A
  • USP Stage 6 PF or posting date: N/A

E-09 Croscarmellose Sodium
USP Title: Croscarmellose/ Sodium
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: First

E-10 Microcrystalline Cellulose
USP Title: Microcrystalline Cellulose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-11 Cellulose, Powdered
USP Title: Powdered Cellulose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-12 Cellulose Acetate
USP Title: Cellulose Acetate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-13 Cellulose Acetate Phthalate
USP Title: Cellacefate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-14 Citric Acid, Anhydrous
USP Title: Citric Acid
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Robert Lafaver
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2

E-15 Citric Acid, Monohydrate
USP Title: Citric Acid Monohydrate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2

E-16 Crospovidone
USP Title: Crospovidone
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: First

E-17 Ethylcellulose
USP Title: Ethylcellulose USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-18 Hydroxyethylcellulose
USP Title: Hydroxyethyl cellulose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-19 Hydroxypropylcellulose
USP Title: Hydroxypropyl cellulose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 35(3)
  • USP Stage 6 PF or posting date:

E-20 Hydroxypropylcellulose, Low Substituted
USP Title: Low-substituted Hydroxypropyl cellulose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 35(3)
  • USP Stage 6 PF or posting date:

E-21 Hydroxypropylmethylcellulose
USP Title: Hypromellose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: First

E-22 Hypromellose Phthalate
USP Title: Hypromellose Phthalate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: First

E-23 Lactose, Anhydrous
USP Title: Anhydrous Lactose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 3

E-24 Lactose, Monohydrate
USP Title: Lactose, Monohydrate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 2

E-25 Magnesium Stearate
USP Title: Magnesium Stearate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Correction 3

E-26 Methylcellulose
USP Title: Methylcellulose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 1

E-27 Methyl Paraben
USP Title: Methylparaben
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1, Correction 1

E-28 Petrolatum
USP Title: Petrolatum
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 35(5)
  • USP Stage 6 PF or posting date:

E-29 Petrolatum, White
USP Title: White Petrolatum
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 35(5)
  • USP Stage 6 PF or posting date:

E-30 Polyethylene Glycol
USP Title: Polyethylene Glycol
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 31(3)
  • USP Stage 6 PF or posting date:

E-31 Polysorbate 80
USP Title: Polysorbate 80
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1, Correction 1

E-32 Povidone
USP Title: Povidone
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: First

E-33 Saccharin
USP Title: Saccharin
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-34 Saccharin, Sodium
USP Title: Saccharin Sodium
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore

Lead PDG Pharmacopeia: USP
Current PDG version: Revision 1

E-35 Saccharin, Calcium
USP Title: Saccharin Calcium
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Removed from PDG Work Program 01–Jun–2011

E-36 Silicon Dioxide
USP Title: Silicon Dioxide
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 31(4)
  • USP Stage 6 PF or posting date:

E-37 Silicon Dioxide, Colloidal
USP Title: Colloidal Silicon Dioxide
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 31(4)
  • USP Stage 6 PF or posting date:

E-38 Sodium Chloride
USP Title: Sodium Chloride
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 2

E-39 Sodium Starch Glycolate
USP Title: Sodium Starch Glycolate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Revision 3

E-40 Starch, Corn
USP Title: Corn Starch
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 2

E-41 Starch, Potato
USP Title: Potato Starch
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 2

E-42 Starch, Rice
USP Title: Rice Starch
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: First

E-43 Starch, Wheat
USP Title: Wheat Starch
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 2

E-44 Stearic Acid
USP Title: Stearic Acid
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: First

E-45 Sucrose
USP Title: Sucrose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-46 Talc
USP Title: Talc
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-47 Titanium Dioxide
USP Title: Titanium Dioxide
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 30(4)
  • USP Stage 6 PF or posting date: Removed from PDG Work Program 01–Jun–2011

E-48 Ethyl Paraben
USP Title: Ethylparabenv USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-49 Propyl Paraben
USP Title: Propylparaben
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-50 Butyl Paraben
USP Title: Butylparaben
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Revision 1

E-51 Glycerin
USP Title: Glycerin
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF:
  • USP Stage 6 PF or posting date:

E-52 Carmellose
USP Title: Carmellose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Revision 1

E-53 Calcium Carbonate
USP Title: Calcium Carbonate
USP Expert Committee (2010–2015): Monographs—Dietary Supplements
USP Scientific Liaison: Huy Dinh
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF:
  • USP Stage 6 PF or posting date:

E-54 Copovidone
USP Title: Copovidone
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 32(6)
  • USP Stage 6 PF or posting date:

E-55a Gelatin, gelling type and 55b, non-gelling type
USP Title: Gelatin
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: First

E-56 Glucose Monohydrate/Anhydrous
USP Title: Liquid Glucose
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Hong Wang
Lead PDG Pharmacopeia: EP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 33(6)
  • USP Stage 6 PF or posting date:

E-57 Glyceryl Monostearate
USP Title: Glyceryl Monostearate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Removed from PDG Work Program: 09–Nov–2011

E-58 Mannitol
USP Title: Mannitol
USP Expert Committee (2010–2015): Monographs—Small Molecules 4
USP Scientific Liaison: Sujatha Ramakrishnaa
Lead PDG Pharmacopeia: EP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 34(6)
  • USP Stage 6 PF or posting date:

E-59 Propylene Glycol
USP Title: Propylene Glycol
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF: 33(2)
  • USP Stage 6 PF or posting date:

E-60 Sodium Laurylsulfate
USP Title: Sodium Lauryl Sulfate
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF:
  • USP Stage 6 PF or posting date:

E-61 Starch, Pregelatinized
USP Title: Pregelatinized Starch
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: JP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF:
  • USP Stage 6 PF or posting date:

E-62 SWFI in Containers
USP Title: Sterile Water for Injection
USP Expert Committee (2010–2015): General Chapters—Chemical Analysis
USP Scientific Liaison: Antonio Hernandez-Cardoso
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF:
  • USP Stage 6 PF or posting date:

E-63 Lactose for Inhalation
USP Title: TBD
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: USP
Current PDG version: Not signed off

  • PDG sign-off: N/A
  • USP Stage 4 PF:
  • USP Stage 6 PF or posting date:

E-64 Isomalt
USP Title: Isomalt
USP Expert Committee (2010–2015): Monographs—Excipients
USP Scientific Liaison: Kevin Moore
Lead PDG Pharmacopeia: EP
Current PDG version: First