Calcium Chloride BP USP IP Dihydrate Manufacturers

Anmol Chemicals is the pioneer manufacturers of Calcium Chloride, Pharmaceutical Excipients Food & Flavor chemicals in India. We offer Halal and Kosher Calcium Chloride made in an ISO9001, ISO22000 (FSSC22000) cGMP and GLP certified facility. Our group has several manufacturing facilities spread across the world, supported by toll manufacturers and representatives in UAE, Europe, Africa, USA, China and has several associated manufacturing facilities spread across India. All the Information on Physics, Chemistry, Applications, Uses and Technology on Manufacture of Calcium Chloride is in these pages.

The units have one or more of the certifications like FDA GMP, ISO 9001, ISO 22000, HACCP, REACH, Kosher & Halal

CALCIUM CHLORIDE DIHYDRATE BP USP IP MANUFACTURERS

We offer Calcium Chloride IP BP USP AR ACS Analytical Reagent Extra Pure or FCC Food Grade made at our FDA approved world class plant Anmol Chemicals an ISO-9001-2008, ISO-22000-2005 HACCP Certified Company using standard GMP techniques

CALCIUM CHLORIDE DIHYDRATE IP

INDIAN PHARMACOPOEIA
(CaCl2.2H2O)
Molecular Weight - 147.02
Description: White crystalline powder or granules or fragments; Odorless; Hygroscopic.
Solubility: Freely soluble in water & Ethanol(95%).
Assay: Content not less than 97% and not more than 103% of CaCl2.2H2O.
Clarity & Color of Solution: A 10% w/w Solution is clear & colorless.
Acidity & Alkalinity: To a 10% freshly prepared w/w solution add 2 drops of phenolphthalein solution. Titrate it with 0.01N HCl or 0.01N NaOH; Not more than 0.2ml is needed.
Arsenic: 3 ppm max
Iron: 20 ppm max
Heavy Metals: 10 ppm max
Magnesium & Alkali Salts: 1% ppm max
Aluminum & Phosphate: To pass the test.
Barium: To pass the test.
Sulphate: 300 ppm max

Calcium Chloride USP

Assay— Calcium Chloride contains an amount of CaCl2 equivalent to not less than 99.0 percent and not more than 107.0 percent of CaCl2·2H2O.
Packaging and storage— Preserve in tight containers.
Labeling— Where Calcium Chloride is intended for use in hem dialysis, it is so labeled.
Identification— A solution (1 in 10) responds to the tests for Calcium and for Chloride.
pH: between 4.5 and 9.2, in a solution (1 in 20).
Aluminum (where it is labeled as intended for use in hem dialysis)— the limit is 1 4g per g.
Iron, aluminum, and phosphate— To a solution (1 in 20) add 2 drops of 3 N hydrochloric acid and 1 drop of phenolphthalein TS. Then add ammonium chloride–ammonium hydroxide TS, drop wise, until the solution is faintly pink, add 2 drops in excess, and heat the liquid to boiling: no turbidity or precipitate is produced.
Heavy metals— the limit is 0.001%.
Limit of magnesium and alkali salts— Dissolve 1 g in about 50 mL of water, add 500 mg of ammonium chloride, and proceed as directed in the test for Limit of magnesium and alkali salts under Calcium Carbonate, beginning with “heat the solution, and boil for 1 minute”: the weight of the residue does not exceed 5 mg (1.0%).
Organic volatile impurities meets the requirements.

Calcium Chloride BP Dihydrate Specifications

CHARACTERS
Appearance
White or almost white, crystalline powder, hygroscopic.
Solubility
Freely soluble in water, soluble in ethanol (96 per cent).

IDENTIFICATION
Solution S (see Tests) gives reaction of chlorides.
It gives the reactions of calcium.
It complies with the limits of the assay.

TESTS
Solution S
Dissolve 10.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely colored than reference solution.
Acidity or alkalinity: To 10 ml of freshly prepared solution S add 0.1 ml of phenolphthalein solution. If the solution is red, not more than 0.2 ml of 0.01 M hydrochloric acid is required to discharge the color and if the solution is colorless, not more than 0.2 ml of 0.01 M sodium hydroxide is required to turn it red.
Sulphates: Maximum 300 ppm.
Aluminium: To 10 ml of solution S add 2 ml of ammonium chloride solution R and 1 ml of dilute ammonia and boil the solution. No turbidity or precipitate is formed.
If intended for use in the manufacture of dialysis solutions, the above test is replaced by the test for Aluminium maximum 1 ppm.
Barium: To 10 ml of solution S add 1 ml of calcium Sulphate solution R. After at least 15 min, any opalescence in the solution is not more intense than that in a mixture of 1 ml of distilled water and 10 ml of solution S.
Iron: Maximum 10 ppm, determined on solution S.
Magnesium and alkali metals: Maximum 0.5 per cent.
Heavy metals: Maximum 20 ppm.

Calcium Chloride Hexahydrate BP Specifications

CHARACTERS
Appearance
White or almost white, crystalline mass or colorless crystals.
Solubility
Very soluble in water, freely soluble in ethanol (96 per cent).
It solidifies at about 29C.

IDENTIFICATION
Solution S (see Tests) gives reaction of chlorides.
It gives the reactions of calcium.
It complies with the limits of the assay.

TESTS
Solution S
Dissolve 15.0 g in carbon dioxide-free water prepared from distilled water R and dilute to 100 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely colored than reference solution.
Acidity or alkalinity: To 10 ml of freshly prepared solution S add 0.1 ml of phenolphthalein solution. If the solution is red, not more than 0.2 ml of 0.01 M hydrochloric acid is required to discharge the color and if the solution is colorless, not more than 0.2 ml of 0.01 M sodium hydroxide is required to turn it red.
Sulphates: Maximum 200 ppm.
Aluminium: To 10 ml of solution S add 2 ml of ammonium chloride solution R and 1 ml of dilute ammonia R1 . Heat to boiling. No turbidity or precipitate is formed. If intended for use in the manufacture of dialysis solutions, the above test is replaced by the test for Aluminium : maximum 1 ppm.
Barium: To 10 ml of solution S add 1 ml of calcium Sulphate solution. After at least 15 min, any opalescence in the solution is not more intense than that in a mixture of 1 ml of distilled water and 10 ml of solution S.
Iron: Maximum 7 ppm, determined on solution S.
Magnesium and alkali metals: Maximum 0.3 per cent.
Heavy metals Maximum 15 ppm.

Calcium Chloride Injection as per USP Specifications

Calcium Chloride Injection is a sterile solution of Calcium Chloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of CaCl2·2H2O.

Packaging and storage— Preserve in single-dose containers, preferably of Type I glass.
Identification— It responds to the tests for Calcium and Chloride.
Bacterial end toxins— It contains not more than 0.2 USP End toxin Unit per mg of calcium chloride.
pH: between 5.5 and 7.5 in the undiluted Injection, except where the concentration is greater than 1 in 20, in which case this range applies to the Injection diluted with water to yield a concentration of 1 in 20.
Particulate matter: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections 1.

Calcium Chloride BP IP USP Dihydrate manufacturers at:

Anmol Chemicals
S-8, SARIFA MANSION, 2ND FLANK ROAD, CHINCHBUNDER, MUMBAI 400009, INDIA
TEL: (OFFICE) 91-22-23770100, 23726950, 23774610, 23723564. FAX: 91-22-23728264

Exports to USA, Canada, UAE, Dubai, South Africa, Tanzania, Kenya, Nigeria, Egypt, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Europe Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, etc.