 |
Cholecalciferol or Vitamin D3 USP FCC Food Grade Supplier Exporter Manufacturers' Representative |
Email: info@ammol.org |
Call Toll Free +1-855-552-6665 |
Quick Links to Products: Ascorbic Acid | Calcium Citrate | Cholecalciferol or Vitamin D3 Suppliers | DL Alpha Tocopherol | Micro Encapsulated Sodium Ascorbate | Potassium Ascorbate | Sodium Adipate | Sodium Ascorbate | Sodium Erythorbate | and more -- |
Cholecalciferol or Vitamin D3
CAS Number: 67-97-0
Molecular Formula: C27H44O
Molecular Weight: 384.64
Cholecalciferol or Vitamin D3
Cholecalciferol USP Grade Specifications:
C27H44O --- 384.64
9,10-Secocholesta-5,7,10(19)-trien-3-ol, (3β,5Z ,7E)-;
Cholecalciferol CAS 67-97-0
UNII: 1C6V77QF41
DEFINITION
Cholecalciferol contains NLT 97.0% and NMT 103.0% of cholecalciferol (C27H44O).
IDENTIFICATION
A. Infrared Absorption: Wavelength range: 2–12 µm
B. Ultraviolet Absorption
Analytical wavelength: 265 nm
Sample solution: 10 µg/mL in alcohol
Acceptance criteria: Meets the requirements in the chapter. Absorptivities do not differ by more than 3.0%.
C.
Sample solution: 0.5 mg in 5 mL of chloroform
Analysis: Add 0.3 mL of acetic anhydride and 0.1 mL of sulfuric acid to the Sample solution and shake vigorously.
Acceptance criteria: A bright red color is produced, and it rapidly changes through violet and blue to green.
D. Thin-Layer Chromatography: To pass the test.
Optical Rotation - Specific Rotation: To pass the test.
Acceptance criteria: +105° to +112°
Packaging and Storage: Preserve in hermetically sealed containers under nitrogen, and store in a cool place protected from light.
We also supply Cholecalciferol or Vitamin D3 Solution.
Vitamin D3 FCC Food Grade Specifications:
Cholecalciferol; Vitamin D
C27H44O Formula weight 384.65
CAS 67-97-0
DESCRIPTION
Vitamin D3 occurs as white crystals. It is affected by air and by light. It is insoluble in water. It is soluble in alcohol, in chloroform, and in fatty oils.
Function: Nutrient.
Identification:
A. Prepare without heating, and handle without delay, (a)a 1:100 solution of squalane:chloroform containing 50 mg of sample per milliliter; and (b) a solution of USP Cholecalciferol Reference Standard using the same solvent and producing a solution with the same concentration. Spot 10 _L each of the Sample Solution and of the Cholecalciferol Standard Solution on a line parallel to and about 2.5 cm from the bottom edge of a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel containing a suitable fluorescing substance. Place the plate in a developing chamber containing, and equilibrated with, a mixture of equal volumes of cyclohexane and ether. Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Perform the development and subsequent operations in the dark. Remove the plate from the chamber, allow the solvent to evaporate, and spray with a 1:50 solution of acetyl chloride: antimony trichloride. The chromatogram obtained with the Sample Solution shows a yellow-orange area (cholecalciferol) having the same Rf value as the area of the Cholecalciferol Standard Solution and may show a violet area, attributed to 7-dehydrocholesterol, below the cholecalciferol area.
B. The infrared absorption spectrum of a potassium bromide dispersion of the sample, in the range of 2 to 12 _m, exhibits maxima only at the same wavelengths as those of a similar preparation of USP Cholecalciferol Reference Standard.
C. The ultraviolet absorption spectrum of the sample in a 1:100,000 solution in ethanol exhibits inflections at the same wavelengths as that of USP Cholecalciferol Reference Standard, similarly prepared, and the respective absorptivities at the point of maximum absorbance occurring at about 265 nm do not differ by more than 3.0%.
Assay: Not less than 97.0% and not more than 103.0% of C27H44O.
Melting Range: Between 84C and 89C.
Optical (Specific) Rotation [α]D25°: Between +105° and +112°.
Colecalciferol BP Ph Eur Grade is also supplied:
C27H44O --- 384.6 --- CAS 67-97-0
Action and use: Vitamin D3 analogue.
DEFINITION
(5Z,7E)-9,10-Secocholesta-5,7,10(19)-trien-3β-ol.
Content: 97.0 per cent to 102.0 per cent.
Colecalciferol Concentrate (Powder Form) BP Ph Eur Grade is also supplied:
Action and use: Vitamin D analogue (Vitamin D3).
DEFINITION
Powder concentrate obtained by dispersing an oily solution of Cholecalciferol (0072) in an appropriate matrix, which is usually based on a combination of gelatin and carbohydrates of suitable quality, authorised by the competent authority.
Content: 90.0 per cent to 110.0 per cent of the cholecalciferol content stated on the label, which is not less than 100 000 IU/g.
It may contain suitable stabilisers such as antioxidants.
Colecalciferol Concentrate (Oily Form) BP Ph Eur Grade is also supplied:
Action and use: Vitamin D analogue (Vitamin D3)
DEFINITION
Solution of Cholecalciferol in a suitable vegetable fatty oil, authorised by the competent authority.
Content: 90.0 per cent to 110.0 per cent of the cholecalciferol content stated on the label, which is not less than 500 000 IU/g.
It may contain suitable stabilisers such as antioxidants.
Please visit SDS Safety Data Sheet of Cholecalciferol or Vitamin D3 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