Bromocresol Green Sodium Salt

Calamine BP
Action and use:Antipruritic.

DEFINITION
Calamine is a basic zinc carbonate suitably coloured with iron(III) oxide.

CHARACTERISTICS
An amorphous, impalpable, pink or reddish brown powder, the colour depending on the variety and amount of iron(III) oxide present and the process by which it is incorporated. Practically insoluble in water. It dissolves with effervescence in hydrochloric acid.

IDENTIFICATION
A. Yields the reactions characteristic of carbonates.
B. To 2 g add 5 ml of hydrochloric acid and heat to boiling; if necessary, add hydrochloric acid drop wise until a bright yellow solution is obtained. Cool and add 13.5 M ammonia until the first sign of precipitate (solution A). The solution yields characteristic of iron salts. Dilute 1 ml of solution A to 5 ml with water; the solution yields the reaction characteristic of zinc salts.

TESTS
Calcium: Dissolve 0.50 g in a mixture of 10 ml of water and 2.5 ml of glacial acetic acid and filter. To 0.5 ml of the filtrate add 15 ml of 5 M ammonia and 2 ml of a 2.5% w/v solution of ammonium oxalate and allow to stand for 2 minutes. The solution remains clear.
Soluble barium salts:To the remainder of the filtrate obtained in the test for Calcium add 2 ml of 1 M sulphuric acid and allow to stand for 5 minutes. The solution remains clear.
Lead: Not more than 150 ppm when determined by atomic absorption spectrophotometry ,
Chloride: Dissolve 0.15 g in water with the addition of 1 ml of nitric acid , filter and dilute to 30 ml with water. The resulting solution complies with the limit test for chlorides (0.07%).
Sulphate: Dissolve 0.1 g in water with the addition of 3 ml of 2 M hydrochloric acid , filter and dilute to 60 ml with water. The resulting solution complies with the limit test for sulphates, (0.6%).
Ethanol-soluble dyes: Shake 1.0 g with 10 ml of ethanol (90%) and filter. The filtrate is colourless,.
Matter insoluble in hydrochloric acid: Dissolve 1 g in 20 ml of warm 2 M hydrochloric acid and filter. The residue, when washed with water and dried to constant weight at 105C, weighs not more than 10 mg.
Water-soluble dyes: Shake 1.0 g with 10 ml of water and filter. The filtrate is colourless.
Residue on ignition: 68.0 to 74.0%, when ignited at a temperature not lower than 900C until, after further ignition, two successive weighing do not differ by more than 0.2% of the weight of the residue. Use 1 g.

Calamine USP Grade Specifications:
Iron oxide (Fe2O3), mixture with zinc oxide;
Calamine (pharmaceutical preparation)) CAS 8011-96-9

DEFINITION
Calamine is Zinc Oxide with a small proportion of ferric oxide, and contains, after ignition, NLT 98.0% and NMT 100.5% of zinc oxide (ZnO).

IDENTIFICATION
A. Identification Tests—General, Zinc
B.
Sample: 1 g
Analysis: Add 10 mL of 3 N hydrochloric acid to the Sample, heat to boil, and filter.
Acceptance criteria: The filtrate assumes a reddish color upon the addition of ammonium thiocyanate.

Arsenic: NMT 8 ppm
Calcium: To pass the test.
Calcium or Magnesium: To pass the test.
Lead: To pass the test.
Acid-Insoluble Substances:
Sample: 2.0 g
Analysis: Dissolve the Sample in 50 mL of 3 N hydrochloric acid. If an insoluble residue remains, collect it on a tared filter, wash with water, and dry at 105C for 1 h. Cool, and weigh.
Acceptance criteria: NMT 40 mg (2.0%)
Alkaline Substances:
Sample: 1.0 g
Analysis: Digest the Sample with 20 mL of water on a steam bath for 15 min, filter, and add 2 drops of phenolphthalein.
Acceptance criteria: If a red color is produced, NMT 0.20 mL of 0.10 N sulfuric acid is required to discharge it.
Loss on Ignition: NMT 2.0% at 500C.
Microbial Enumeration Tests and Tests for Specified Microorganisms: It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.

Calamine IP
IP grade calamine is also ofered.

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.