 |
Microcrystalline Cellulose + Dicalcium Phosphate GMP Grade Supplier Exporter Manufacturers' Representative |
Email: info@ammol.org |
Call Toll Free +1-855-552-6665 |
Microcrystalline Cellulose + Dicalcium Phosphate
Microcrystalline Cellulose + Dicalcium Phosphate
Microcrystalline cellulose and Calcium phosphate compositions useful as pharmaceutical excipients as direct compression. The combination formula is better suited than the individual excipients,
Typical Compositions and Specifications of Microcrystalline Cellulose + Dicalcium Phosphate:
Appearance: White Free-flowing powder.
Identification:
Test A:
A. Sift 20 g of sample for 5 min on an air-jet sieve equipped with a screen having 38-_m openings. If more than 5% is retained on the screen, mix 30 g of sample with 270 mL of water; otherwise, mix 45 g of sample with 255 mL of water. Mix for 5 min in a single-speed, high-speed (equal to or greater than 18,000 rpm) power blender (use a Waring Blender, Model 700G, or equivalent) that has a clover-shaped jar design. The jar and blades meet the following specifications: The jar has a 7.0-cm id at the bottom and a 9.2-cm id at the top and an overall height of 21.9 cm, and the four blades are arranged so that two of the blades are pointed up and two are pointed down. Transfer 100 mL of the dispersion into a 100-mL graduated cylinder and allow it to stand for 3 h. A white, opaque, bubble-free dispersion that does not form a supernatant liquid at the surface is obtained.
B. Add a few drops of iodine TS to 20 mL of the dispersion obtained in Identification Test A, and mix. No purple to blue or blue color appears.
Test B: Dissolve about 20 mg of the substance to be examined or the prescribed quantity in 5 mL of acetic acid R. Add 0.5 mL of potassium ferrocyanide solution R. The solution remains clear. Add about 50 mg of ammonium chloride R. A white, crystalline precipitate is formed.
Test C: Dissolve 0.1 g of Anhydrous Dibasic Calcium Phosphate the Sample in 5 mL of diluted nitric acid. Warm the solution to 70C and add 2 mL of 10% ammonium molybdate solution (freshly prepared). Acceptance criteria: A yellow precipitate of ammonium phosphomolybdate is formed.
Loss on Drying at 105C for 3h: NMT 5.0%
pH(5% solution): Between 5.5 to 7.5
Heavy metal: NMT 0.001%
Assay for DCP: NLT 21.0% and NMT 29.0% or as desired by the buyer.
Please visit SDS Safety Data Sheet of Microcrystalline Cellulose + Dicalcium Phosphate Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org