Saint Mary’s University

School of Health and Natural Sciences

QUALITY CONTROL MONOGRAPH 1

Submitted by:
Jacinto, Jerryco
Aguinaldo, Kisserie Joy Urica
Baldonado, Kristine
Daguio, Helen Genevieve
Fidel, Marilou
Navan, Celenika
Ranil, Alyka Mayzee

Submitted to:
Brent Jericko Narciso, RPh

February 3, 2020
 Saint Mary’s University
School of Health and Natural Sciences
BAYOMBONG, NUEVA VIZCAYA 3700
Pharmaceutical Analysis 2 (Laboratory)
INTRODUCTION
Calamine, Powder, USP (CA115) is a mixture of zinc oxide with a small amount of ferric
oxide and is used in lotions, liniments, and ointments. It is normally known for its anti-pruritic,
mild antiseptic and gentle toning and astringent properties to relieve redness, stinging and irritation
of the skin. It can be used as an absorbent and soothing base in face powders, dusting powders and
toothpastes. It appears as an odorless, pink powder and is insoluble in water. Calamine as an anti-
itch medicine works by causing a cooling sensation as it evaporates on the skin. Calamine also
dries oozing or weeping from minor skin irritation.
MATERIALS
Calamine powder Potassium chromate
Diluted Hydrochloric acid Ammonium thiocyanate
Ammonium chloride TS Phenolphthalein
Methyl orange TS Conc. Sulfuric acid
Ammonia Sodium hydroxide
Ammonium oxalate Barium hydroxide
Glacial acetic acid 95% ethyl alcohol

PROCEDURES
Solubility: Calamine is insoluble in water, but is almost completely soluble in mineral
acids.
Identification. Treat 1 gram of calamine with 10 ml of diluted HCl. If an insoluble residue
remains, collect it on a tared filter, wash with water, dry at 105˚C for 1 hour, cool and weigh. The
weight should not exceed 40 mg. (2%)
Calcium. Dissolve 1 gram of calamine in 25 ml diluted HCl, filter add ammonia TS. To 10
ml of this solution add 2 ml of ammonium oxalate TS. Not more than a slight turbidity is produced.
Lead. To 1 gram of calamine add 15 ml of water and stir well. Add 3 ml of glacial acetic
acid, warm on steam bath until dissolved and filter. On the addition of 5 drops of potassium
chromate TS to the filtrate no turbidity is produced.
Alkaline substances. Digest 1 gram of calamine with 20 ml of water on a steam bath for
15 minutes, filter and add 2 drops of phenolphthalein TS. If a red color is produced, not more than
0.2 ml of 0.1 N sulfuric acid is required to discharge it.

RESULTS
Solubility
5ml H2O + pinch of Calamine powder Insoluble
2ml H2SO4 + 1g Calamine powder Soluble
2ml HCl + 1g Calamine powder Soluble
2ml Nitric acid + 1g Calamine powder Soluble

Calamine is insoluble in water and practically completely soluble in mineral acids (USP).

Identification
As a result, in this test, the heated and cooled tared filter paper weigh 1.3 g. the weight
exceeded the 40 mg limit given.
Calcium
The presence of calcium in the calamine powder was positive, the result had shown a color
not more than slight turbidity.
 Saint Mary’s University
School of Health and Natural Sciences
BAYOMBONG, NUEVA VIZCAYA 3700
Pharmaceutical Analysis 2 (Laboratory)

Lead
After adding 5 drops of potassium dichromate the solution doesn’t show any cloudy
appearance. Turbidity isn’t present.
Alkaline Substances
When we added 2 drops of phenolphthalein in calamine with 20 ml of water it cannot
produced red coloration and base on our research the phenolphthalein is an acid/base indicator. It
is colorless when it is an acid. Calamine with 20 ml of water is a base so that when we added
phenolphthalein to the solution it must produce red or pink color.

CONCLUSION
On the activity “Quality Control Monograph of Calamine”, there were different tests that are
included in the experiment: Solubility, identification, alkaline substances, calcium, and lead. First
test, the solubility of calamine was determined and found out that calamine was soluble in HCl,
H2SO4, and HNO3, while it is insoluble with water. The second test, there was an intensity in the
weight of the filter paper due to the existence of the residue from the calamine. third test, when
phenolphthalein was added to test the alkaline substance present, it turned pink, and when sulfuric
acid was added, it goes back its colorless state. The fourth test indicated not more than a slight
turbidity. This quality control monograph of calamine helps provide guidelines in managing the
quality control of the substance since various tests were performed.

GUIDE QUESTIONS
1. What is the composition of Calamine lotion?
Calamine lotion composition includes Active Ingredients= Calamine 8% and Zinc Oxide 8%
Inactive ingredients on the other hand are Bentonite magma, calcium hydroxide, glycerin, purified
water. The primary purpose of calamine lotion is skin protectant.
2. What are the intended use of Calamine lotion?
Calamine is an anti-itch medicine that works by causing a cooling sensation as it evaporates
on your skin. Calamine also dries oozing or weeping from minor skin irritation. Calamine topical
(for the skin) is used to treat itching and skin irritation caused by chickenpox, insect bites or stings,
measles, eczema, sunburn, poison ivy, and other minor skin conditions.
3. What is the proper usage of Calamine lotion?
Use this medication on the skin only. Follow all directions on the product package, or use as
directed by your doctor. Shake the bottle well before using. Apply the medication with a cotton
pad, and allow the medication to dry on the skin. If you are uncertain about any of the information,
consult your doctor or pharmacist. Avoid getting this medication in the eyes, mouth, nose, and
genital/anal areas. If you do get the medication in those areas, flush with plenty of water.
4. Provide the physical and chemical property of Calamine powder.
Physical and Chemical Properties of Calamine:
 It is pink colour powder
 It is odorless
 It is insoluble in water but soluble in most of mineral acids
 It passed through sieve number 100
 Its melting point is 1975 C
 Saint Mary’s University
School of Health and Natural Sciences
BAYOMBONG, NUEVA VIZCAYA 3700
Pharmaceutical Analysis 2 (Laboratory)

5. What are the test used to determine the purity of Calamine Powder?

These are the possible tests conducted to

DOCUMENTATION
Solubility

2ml H2SO4 + 1g
Calamine powder:
5ml H2O + pinch of Calamine 2ml HCl + 1g Calamine
Soluble
powder: Insoluble powder: Soluble

2ml Nitric acid + 1g

1g of Calamine 1g of Calamine with Filter and get the

Wash with water Dry for 1 hour Final measurement

Calcium
 Saint Mary’s University
School of Health and Natural Sciences
BAYOMBONG, NUEVA VIZCAYA 3700
Pharmaceutical Analysis 2 (Laboratory)

Lead
 Saint Mary’s University
School of Health and Natural Sciences
BAYOMBONG, NUEVA VIZCAYA 3700
Pharmaceutical Analysis 2 (Laboratory)
Alkaline substances
 Saint Mary’s University
School of Health and Natural Sciences
BAYOMBONG, NUEVA VIZCAYA 3700
Pharmaceutical Analysis 2 (Laboratory)
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file:///C:/Users/kisserie%20aguinaldo/Downloads/ProductSpecification.pdf