Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol USP BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol CAS Number 67-97-0, EINECS EC Number: 200-673-2, Molecular Formula: C27H44O, Molecular Weight: 384.64, HS Code 30049099 or 29362990

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol.

Cholecalciferol, commonly called Vitamin D3 has a few health benefits, including helping the body absorb calcium. Foods such as fish, beef liver, eggs, and cheese naturally contain vitamin D3. It can also be produced in the skin following exposure to the sun. Cholecalciferol (vitamin D3) is used as a dietary supplement when the amount of vitamin D in the diet is not enough.

General Properties and Specifications of Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol:
Appearance: White to off-white powder.
Assay: 98.5%
Melting point: 83-86 C literature.
Specific Rotation: 105° to 112°
Storage: 2C to 8C.

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.

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.

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.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

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Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 17-June-23

Product Name & Other Names: Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol.
CAS No.: 67-97-0
EINECS EC No.: 200-673-2
Molecular Formula: C27H44O
Molecular Weight: 384.64
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP):

Acute toxicity, Oral (Category 2), H300
Acute toxicity, Inhalation (Category 2), H330
Acute toxicity, Dermal (Category 1), H310
Specific target organ toxicity - repeated exposure Kidney, (Category 1), H372

Hazard statements:
H300: Fatal if swallowed.
H310: Fatal in contact with skin.
H330: Fatal if inhaled.
H372 Causes damage to organs through prolonged or repeated exposure if swallowed.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262 Do not get in eyes, on skin, or on clothing.
P264: Wash … thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P330: Rinse mouth.
P304+340+310: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER/doctor.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
P405: Store locked up.
P501: Dispose of contents/container to authorized agents only.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard symbol:
T+ Very toxic
R-phrases:
R26/27/28 Very toxic by inhalation, in contact with skin and if swallowed.
R48 Danger of serious damage to health by prolonged exposure.

Product Name & Other Names: Cholecalciferol or Vitamin D3 or 7-Dehydrocholesterol Activated or Activated 7-dehydrocholesterol, Calciol.
CAS No.: 67-97-0
EINECS EC No.: 200-673-2

Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.

Products of Combustion: Carbon dioxide, Carbon monoxide and fumes.
Explosion: May be explosive in presence of heat.
Fire Extinguishing Media: Use dry powder or dry sand should be preferred. Do not use solid water stream. Flammable liquid and vapor. For small (incipient) fires, use media such as "alcohol" foam, dry chemical, or carbon dioxide. For large fires, apply water from as far as possible. Use large quantities (flooding) of water applied as a mist or spray. Vapors are heavier than air and may travel to a source of ignition and flash back. Vapors can spread along the ground and collect in low or confined areas. Never direct a water jet in the container to prevent any splashing of the product which could cause spreading of the fire. Cool containing vessels with water jet to prevent pressure build-up, auto-ignition, or explosion.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Small Spill: Avoid mist formation. Avoid breathing mist/vapors. Ensure adequate ventilation. Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: Remove all sources of ignition. Provide proper ventilation. Keep people away from upwind of spill/leak. Entry to non-involved personnel should be controlled around the leakage area by roping off. Absorb the material on a porous, inert material such as earth, sand, or vermiculite. Carefully sweep up the material without causing dust. Dispose it of in accordance with local regulations.
Large spillages should be contained by use of sand or another inert material. The spillage should be transferred to a suitable container and recovered or disposed of in accordance with local regulations. Because of the danger of spontaneous combustion, any combustible material, such as cloth, used for cleaning spillages, should be saturated with water, and disposed of promptly, preferably by incineration.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. Keep away from heat/sparks/open flame/hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from light, heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents, acids, bases, reducing agents. Store locked up. Storage: 2C to 8C.

Airborne Exposure Limits: Not Established.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance: Powder Solid.
Odor: None.
Odor threshold: Not applicable.
pH: Not available.
Relative density: Not available.
Boiling Point: Not available.
Melting Point: 83-86 C literature
Flash Point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Not available.
Viscosity: Not available.
Molecular Formula: C27H44O
Molecular Weight: 384.64

Stability: Stable under ordinary conditions of use and storage. Vapour/air-mixtures are explosive at high temperature.
Hazardous Decomposition Products: It emits Carbon oxides and Fumes.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents, Acids, Bases, Reducing agents, Acid anhydrides, Acid chloride.
Conditions to Avoid: Incompatibles, oxidizing agents, heat flame & light.

Fatal if inhaled, swallowed and in skin contact.
LD50 Oral - Rat – 42 mg/kg.
LC50 Inhalation - Rat - 4 h – 0.13 to 0.38 mg/l.
LD50 Dermal - Rat - 61 mg/kg.
Carcinogenicity: Not listed by ACGIH, IARC, NTP, or CA Prop 65.
Epidemiology: No information found
Teratogenicity: No information found
Reproductive Effects: No information found
Mutagenicity: No information found
Neurotoxicity: No information found.

Environmental Toxicity:
Toxicity to daphnia and other aquatic invertebrates: NOEC - Daphnia magna (Water flea) - 100 mg/l - 48 h.
Environmental Fate: Not available.
Mobility: Is not likely mobile in the environment due its low water solubility.
Persistence and Degradability: Not available.
Toxicity of the Products of Biodegradation: Not available.

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused contents in accordance with federal, state, and local requirements.

DOT USA, TDG Canada & ADR/RID Europe:
Shipping Name: Toxic solid, organic. (Vitamin D3).
Hazard Class: 6.1(3), Packing Group: II
UN Number: UN2811
IATA & IMDG/IMO:
Shipping Name: Toxic solid, organic. (Vitamin D3).
Hazard Class: 6.1(3), Packing Group: II
UN Number: UN2811.

USA:
SARA 311/312 Hazards: Chronic Health Hazard. See section 2.
California prop. 65: Contains no chemical subject to California Prop 65.

European Labeling in Accordance with EC Directives:
H300: Fatal if swallowed.
H310: Fatal in contact with skin.
H330: Fatal if inhaled.
H372 Causes damage to organs through prolonged or repeated exposure if swallowed.

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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