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Cholecalciferol or Vitamin D3 BP Ph Eur USP FCC Food Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol 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.
Cholecalciferol or Vitamin D3 SDS of Manufacturers
Synonyms: Cholecalciferol or Vitamin D3
CAS Number: 67-97-0, Molecular Weight: 384.64, Chemical Formula: C27H44O, EINECS EC Number: 200-673-2, FEMA: ----,
Cholecalciferol or Vitamin D3 is used as a dietary supplement when the amount of vitamin D in the diet is not enough.
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.
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.
STORAGE
Under nitrogen, in an airtight container, protected from light, at a temperature of 2C to 8C. The contents of an opened container are to be used immediately.
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.
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.
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°.
Keywords: Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 67-97-0 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
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, INDIA
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
26-jun-24
Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, 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 and Laboratory Use only. No other use is permitted.
Fast Selling IP BP Ph Eur EP USP NF JP Analytical Reagent FCC Food Grades of Chemicals by Anmol Chemicals
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Cholecalciferol
Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol BP Ph Eur USP FCC Food Grades Manufacturers