mortar and pestle
Robert P. Shrewsbury
ROBERT P. SHREWSBURY PhD
Beard Hall, Room # 202B
Email: bob_shrewsbury@unc.edu
  Resources

UV/VIS Assays

Progesterone Suppositories

Progesterone

200.0 mg/supp

Silica gel

35.0 mg/supp

Witepsol H-15 base

s.a. *

Mft. 12 suppositories

 
*calculated based on the calibration of the suppository mold
Link to Formulation Record:

Process of Analysis:
Wavelength: 340 nm using quartz glass cuvettes
Sample Preparation: To analyze the progesterone suppositories, two suppositories were selected from the compounded preparation. Each was dissolved in 20 mL of tetrahydrofuran, and when dissolution was complete, the mixture was hand shaken to mix well.  The samples were left to stand overnight.  The supernatant was read.
Standard Solutions: Standard preparations of 150–250 mg/suppository of progesterone were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount.  
Expected Concentration of API: 200 mg per suppository



 
Ketoprofen PLO Emulsion

Ketoprofen

10% w/v

Ethoxy Diglycol

20% v/v

Lecithin Isopropyl Palmitate Solution

22% v/v

Poloxamer 407 20 % Gel

qs 100%

Mft. 10 mL

 

Link to Formulation Record:

Process of Analysis:
Wavelength:340 nm using quartz cuvettes
Sample Preparation:Ketoprofen was analyzed by dissolving a 0.5 mL sample of the PLO emulsion in 20 mL of tetrahydrofuran and reading the dissolved sample.
Standard Solutions: Standard preparations of 8.0% to 11% of ketoprofen were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount.
Expected Concentration of API: 1.0 g/10 mL


 

Hydrocortisone Medication Stick

Hydrocortisone USP, micronized

2.5%

White Beeswax

20%

Cetyl Esters Wax

20%

Mineral Oil

55%

Acacia

5%

Mft. 45 gm Medication Stick

 
Link to Formulation Record:

Process of Analysis:
Wavelength:  242 nm using quartz cuvettes
Sample Preparation: A 250 mg sample was removed from the top of the stick, dissolved in 20 mL of tetrahydrofuran, and when dissolution was complete, the mixture was hand-shaken to mix well. The samples were left to stand overnight. One (1) mL of the supernatant was further diluted with 10 mL of tetrahydrofuran and was read.
Standard Solutions: Standard preparations of 2.0% to 3.0% of hydrocortisone medication sticks were prepared in the same manner as the student preparations, and were used as a linear standard curve to determine the student preparation percentage.
Expected Concentration of API: 2.5%

 

Metoprolol Tablet Triturates

Metoprolol Tartrate USP

625 mg

Sucrose, Powder FCC

qs*

Lactose, Hydrous NF

qs*

Mft. 50 Tablets

 
*calculated based on the calibration of the tablet triturate mold
Link to Formulation Record:

Process of Analysis:
Wavelength: 280 nm using plastic cuvettes
Sample Preparation: A tablet was selected at random from the compounded tablets and dissolved in 20mL of distilled water and read.
Standard Solutions: Standard preparations of 10-15 mg/tablet of metoprolol were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount.
Expected Concentration of API: 12.5 mg per tablet
 

Furosemide Tablet Triturate

Furosemide USP

500 mg

Sucrose, Powder FCC

qs*

Lactose, Hydrous NF

qs*

Mft. 50 Tablets

 
*calculated based on the calibration of the tablet triturate mold
Link to Formulation Record:

Process of Analysis:
Wavelength: 300 nm using plastic cuvettes
Sample Preparation: A tablet was selected at random and dissolved into 20 mL of 75% methanol and 25% distilled water. Samples were sonicated for approximately 20 minutes until dissolved.
Standard Solutions: Standard preparations of 5-15 mg/tablet of furosemide were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount.
Expected Concentration of API: 10 mg per tablet

 

Co-enzyme Q10 Troches
Tartrazine was substituted for Co-enzyme Q10 in the formulation.

Tartrazine (Co-enzyme Q10)

2.4 g

Aspartame

0.55 g

Silica Gel

0.24 g

Acacia

0.5 g

Citric Acid Monohydrate

0.7 g

Flavoring Oil

2-3 drops

Polyethylene Glycol 1450

qs*

Mft. 24 troches

 
*calculated based on the calibration of the troche mold
Link to Formulation Record:

Process of Analysis:
Wavelength: 530 nm using plastic cuvettes
Sample Preparation: A troche was selected at random and dissolved in 20 mL of pH 10 buffer. The samples were left to stand overnight and read.
  • pH 10 buffer:
    • Solution A:
      • 12.37 g boric acid
      • 100 mL 1.0 N sodium hydroxide
      • qs 1 L distilled water
    • Solution B:
      • 0.1 N sodium hydroxide
    • Combine 59.6 mL of Solution A with 40.4 mL of solution B to get the pH 10 buffer used for sample preparation
Standard Solutions: Standard preparations of 50-150 mg/troche of tartrazine were prepared in the same manner as the student preparations, and were used as a linear standard curve to determine the student preparation amount. Make sure the standards are left to stand overnight in order to get a linear curve.
Expected Concentration of API: 100 mg tartrazine per troche

 

Menthol and Phenol Troches

Phenol

0.36 g

Menthol

0.24 g

Aspartame

0.55 g

Silica Gel

0.24 g

Acacia

0.5 g

Citric Acid Monohydrate

0.7 g

Polyethylene Glycol 1450

qs*

Mft. 24 troches

 
Link to Formulation Record:

Process of Analysis:
Wavelength: 270 nm using plastic cuvettes
Sample Preparation: A troche was selected at random and dissolved in 20 mL of pH 10 buffer. A second dilution was prepared by adding 2 mL of the first dilution into 20 mL of pH 10 buffer and was then read.
  • pH 10 buffer:
    • Solution A:
      • 12.37 g boric acid
      • 100 mL 1.0 N sodium hydroxide
      • qs 1 L distilled water
    • Solution B:
      • 0.1 N sodium hydroxide
    • Combine 59.6 mL of Solution A with 40.4 mL of Solution B to get the pH 10 buffer used for sample preparation.
Standard Solutions: Standard preparations of 8.3-20.8 mg/troche of methanol were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount. Make sure the standards are left to stand overnight in order to get a linear curve.
Expected Concentration of API: 15 mg of phenol per troche

 

Lidocaine Dental Gel

Lidocine USP

2%

Carbopol 940 NF

2%

Alcohol USP

90.0%

Distilled Water

6.0%

Mft. 20 g of gel

 
Link to Formulation Record:

Process of Analysis:
Wavelength: 210 nm using plastic cuvettes
Sample Preparation: A 0.5 g sample was dissolved in 20 mL of ethanol and left to stand overnight. Without shaking the first dilution, 0.5 mL of the first dilution was pipetted into 20 mL of ethanol and read. It is important to pre-wet the pipette tip before drawing up the 0.5 mL sample.
Standard Solutions: Standard preparations of 1.5% to 2.5% lidocaine gel were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount.
Expected Concentration of API: 2% lidocaine

 

Salicylic Acid in Flexible Collodion

Salicylic Acid

16.7% (w/v)

Lactic Acid, 88%

16.7% (v/v)

Flexible Collodion

qs

Mft. 30 mL of Solution

 
Link to Formulation Record:

Process of Analysis:
Wavelength: 310 nm using plastic cuvettes
Sample Preparation: A 0.5 mL sample was diluted into 20 mL of methanol. A second dilution was made by adding 0.1 mL of the first dilution into 9 mL of methanol. The second dilution was left to stand overnight then read.
Standard Solutions: Standard preparations of 0% to 23.3% salicylic acid in flexible collodion were prepared in the same manner as the student preparations and were used as a linear standard curve to determine the student preparation amount.
Expected Concentration of API: 16.7% salicylic acid