Cholecalciferol or Vitamin D3 or Colecalciferol BP Ph Eur USP FCC Food Grade Manufacturers Exporters

Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturer and exporter of Cholecalciferol or Vitamin D3 or Colecalciferol BP Ph Eur USP FCC Food Grade, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc. It is manufactured and exported by our associated concern.

Aadhunik Industries and/or associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified. We offer crystals granules in precise micron or mesh size as per buyers needs. We offer very high purity standards as per specifications required.

Specifications of Cholecalciferol or Vitamin D3 or Colecalciferol BP Ph Eur Grade Show/Hide Details

Colecalciferol BP Ph Eur Grade Specifications:
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.
A reversible isomerisation to pre-cholecalciferol takes place in solution, depending on temperature and time. The activity is due to both compounds.
1 mg of cholecalciferol is equivalent to 40000 IU of antirachitic activity (vitamin D) in rats.

CHARACTERS
Appearance: White or almost white crystals.
Solubility: Practically insoluble in water, freely soluble in ethanol (96 per cent), soluble in trimethylpentane and in fatty oils.
It is sensitive to air, heat and light. Solutions in solvents without an antioxidant are unstable and are to be used immediately.

IDENTIFICATION
Infrared absorption spectrophotometry,

TESTS
Specific optical rotation: + 105 to + 112, determined within 30 min of preparing the solution.
Dissolve 0.200 g rapidly in aldehyde-free alcohol without heating and dilute to 25.0 mL with the same solvent.
Related substances: To pass the test.

Specifications of Cholecalciferol or Vitamin D3 or Colecalciferol Concentrate (Powder Form) BP Ph Eur Grade Show/Hide Details

Colecalciferol Concentrate (Powder Form) BP Ph Eur Grade Specifications:
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.

CHARACTERS
Appearance: White or yellowish-white, small particles.
Solubility: Practically insoluble, swells, or forms a dispersion in water, depending on the formulation.

IDENTIFICATION
First identification: A, C
Second identification: A, B
A. Thin-layer chromatography: To pass the test.
B. Ultraviolet and visible absorption spectrophotometry: To pass the test.
C. Examination of the chromatograms obtained in the assay: To pass the test.

Specifications of Cholecalciferol or Vitamin D3 or Colecalciferol Concentrate (Oily Form) BP Ph Eur Grade Show/Hide Details

Colecalciferol Concentrate (Oily Form) BP Ph Eur Grade Specifications:
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.

CHARACTERS
Appearance: Clear, yellow liquid.
Solubility: Practically insoluble in water, slightly soluble in anhydrous ethanol, miscible with solvents of fats.
Partial solidification may occur, depending on the temperature.

IDENTIFICATION
First identification: A, C
Second identification: A, B
A. Thin-layer chromatography. To pass the test.
B. Ultraviolet and visible absorption spectrophotometry.
Test solution Prepare a solution in cyclohexane containing the equivalent of about 400 IU/mL.
Spectral range 250-300 nm.
Absorption maximum at 267 nm.
C. Examine the chromatograms obtained in the assay. To pass the tese.

TESTS
Acid value: Maximum 2.0.
Dissolve 5.0 g in 25 mL of the prescribed mixture of solvents.
Peroxide value: Maximum 20.
Related substances: To pass the test.

Specifications of Cholecalciferol or Vitamin D3 or Colecalciferol USP Grade Specifications Show/Hide Details

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°

Specifications of Cholecalciferol or Vitamin D3 or Colecalciferol FCC Food Grade Show/Hide Details

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.

REQUIREMENTS
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°.

CAS Number 67-97-0, Cholecalciferol or Vitamin D3 manufacturers suppliers exporters at:

manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.