Calamine

Iron oxide (Fe 2O3), mixture with zinc oxide.

Calamine (pharmaceutical preparation) [8011-96-9].

» Calamine is Zinc Oxide with a small proportion of ferric oxide, and contains, after ignition, not
less than 98.0 per cent and not more than 100.5 percent of zinc oxide (ZnO).

Packaging and storage—Preserve in well-closed containers.

Identification—

A: Treat 1 g with 10 mL of 3 N hydrochloric acid, and filter: the filtrate responds to the tests for
Zinc 〈191〉.

B: Treat 1 g with 10 mL of 3 N hydrochloric acid, heat to boiling, and filter: the filtrate assumes a
reddish color upon the addition of ammonium thiocyanate TS.
Microbial enumeration tests 〈61〉 and Tests for specified microorganisms 〈62〉—It meets
the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas
aeruginosa.
Loss on ignition 〈733〉—Weigh accurately about 2 g, and ignite at 500 ° to constant weight: it
loses not more than 2.0% of its weight.
Acid-insoluble substances—Dissolve 2.0 g in 50 mL of 3 N hydrochloric acid. If an insoluble
residue remains, collect it on a tared filter, wash with water, dry at 105 ° for 1 hour, cool, and
weigh: the weight of the residue does not exceed 40 mg (2.0%).

Alkaline substances—Digest 1.0 g 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 0.20 mL of
0.10 N sulfuric acid is required to discharge it.
Arsenic, Method I 〈211〉: 8 ppm.
Calcium—Digest 1 g in 25 mL of 3 N hydrochloric acid for 30 minutes, filter to remove the
insoluble ferric oxide, and add 6 N ammonium hydroxide to the filtrate until the precipitate first
formed is redissolved, then add 5 mL more of 6 N ammonium hydroxide. To 10 mL of this
solution add 2 mL of ammonium oxalate TS: not more than a slight turbidity is produced.
Calcium or magnesium—To another 10-mL portion of the solution prepared for the test for
Calcium add 2 mL of dibasic sodium phosphate TS: not more than a slight turbidity is produced.

Lead—To 1 g add 15 mL of water, stir, then add 3 mL of

glacial acetic acid, and warm on a steam bath until dissolved. Filter, and add 5 drops of
potassium chromate TS: no turbidity is produced.
Assay—Digest about 1.5 g of freshly ignited Calamine, accurately weighed, with 50.0 mL of 1 N
sulfuric acid VS, applying gentle heat until no further solution occurs. Filter the mixture, and
wash the residue on the filter with hot water until the last washing is neutral to litmus paper. T o
the combined filtrate and washings add 2.5 g of ammonium chloride, cool, add methyl orange
TS, and titrate with 1 N sodium hydroxide VS. Each mL of 1 N sulfuric acid is equivalent to
40.69 mg of ZnO.
 Calamine Lotion

» Prepare Calamine Lotion as follows.

 Calamine ............................................................................................................... 80g

 Zinc Oxide.............................................................................................................. 80g
 Glycerin ................................................................................................................. 20mL
 Bentonite Magma ...................................................................................................250mL
 Calcium Hydroxide Topical Solution, a sufficient quantity to make........................1000mL

Dilute the Bentonite Magma with an equal volume of Calcium Hydroxide Topical Solution. Mix
the powders intimately with the Glycerin and about 100 mL of the diluted magma, triturating until
a smooth, uniform paste is formed. Gradually incorporate the remainder of the diluted magma.
Finally add enough Calcium Hydroxide Topical Solution to make 1000 mL, and shake.

If a more viscous consistency in the Calamine Topical Suspension is desired, the quantity of
Bentonite Magma may be increased to not more than 400 mL.
NOTE—Shake the Calamine Topical Suspension before dispensing.

Packaging and storage—Preserve in tight containers.

Microbial enumeration tests 〈61〉 and Tests for specified microorganisms 〈62〉—It meets
the requirements of the tests for absence of Staphylococcus aureus

References:

USP Monographs: Calamine. (n.d.). Retrieved from

http://www.pharmacopeia.cn/v29240/usp29nf24s0_m11250.html

USP Monographs: Calamine. (n.d.). Retrieved from

http://www.pharmacopeia.cn/v29240/usp29nf24s0_m11250.html