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cGMP, GLP - FDA Approved, ISO 9001, ISO 14001, ISO 17025, ISO 45001, HACCP, FSSC 22000, FSSAI, "REACH" Registered, Kosher & Halal Certified. We observe WHO Good Manufacturing Practice GMP and Good Laboratory Practice GLP
Excellence in Excipients and API Manufacturing .DMF Support and Documentations Available
WHO-GMP Certified
Good Manufacturing Practice Certified by World Health Organization
WC, Written Confirmation
for Active Substance to be imported into European Union (EU).Calamine USP BP Ph Eur IP USP Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Calamine and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Calamine BP Ph Eur Grade Specifications
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 8011-96-9DEFINITION
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
Arsenic: NMT 8 ppm
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.
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 PhPh.
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.We also offer Calamine IP Grade.
Keywords: Calamine IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 8011-96-9Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturers
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIAe-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated 11-mar-24Exporters to USA, Canada, UAE, Kwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnak, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial Use only. No other use is permitted.
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