Ergocalciferol or Vitamin D2 or Calciferol BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Ergocalciferol or Vitamin D2 or Calciferol, 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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Ergocalciferol or Vitamin D2 or Calciferol BP Ph Eur FCC Food Grade CAS Number 50-14-6, EINECS EC Number: 200-014-9, Molecular Formula: C28H44O, Molecular Weight: 396.66, HS Code 29362990 or 30049099

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Ergocalciferol or Vitamin D2 or Calciferol BP Ph Eur FCC Food Grade.

Ergocalciferol or Vitamin D2 or Calciferol, is a type of vitamin D found in food and used as a dietary supplement. It works by helping the body to use more of the calcium found in foods or supplements.

General Properties and Specifications of Ergocalciferol or Vitamin D2 or Calciferol:
Appearance: White or slightly yellowish, crystalline powder or white or almost white crystals.
Odor: Odorless.
Melting Point: 115C to 119C.
Solubility: Practically insoluble in water.

Ergocalciferol USP Grade Specifications:
C28H44O --- 396.65
9,10-Secoergosta-5,7,10 (19),22-tetraen-3-ol, (3β,5Z ,7E ,22E )-;
Ergocalciferol CAS 50-14-6
UNII: VS041H42XC

DEFINITION
Ergocalciferol contains NLT 97.0% and NMT 103.0% of ergocalciferol (C28H44O).

IDENTIFICATION
A. Infrared Absorption
B. Ultraviolet Absorption
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 rapidly changes through violet and blue to green.
D. Thin-Layer Chromatography: To pass the test.

Reducing Substances: To pass the test.
Melting Range or Temperature: 115C to 119C.
Optical Rotation, Specific Rotation:
Sample solution: 15 mg/mL in alcohol. [Note— Prepare and use the solution without delay. Use Ergocalciferol from a container opened not longer than 30 min.]
Acceptance criteria: +103° to +106°
Packaging and Storage: Preserve in hermetically sealed containers under nitrogen, and store in a cool place protected from light.

Ergocalciferol BP Ph Eur Grade Specifications:
C28H44O --- 396.7 CAS 50-14-6
Action and use: Vitamin D analogue (Vitamin D2).

DEFINITION
(5Z,7E,22E)-9,10-Secoergosta-5,7,10(19),22-tetraen-3β-ol.
Content: 96.5 per cent to 102.0 per cent.
A suitable antioxidant may be added.
A reversible isomerisation to pre-ergocalciferol takes place in solution, depending on temperature and time. The activity is due to both compounds.
1 mg of ergocalciferol is equivalent to 40 000 IU of antirachitic activity (vitamin D) in rats.

CHARACTERS
Appearance: White or slightly yellowish, crystalline powder or white or almost white crystals.
Solubility: Practically insoluble in water, freely soluble in ethanol (96 per cent) and in methanol, soluble in fatty oils.
It is sensitive to air, heat and light. Solutions in volatile solvents are unstable and are to be used immediately.

IDENTIFICATION
Infrared absorption spectrophotometry.
Specific optical rotation: + 103 to + 107.
Dissolve 0.200 g rapidly and without heating in aldehyde-free alcohol and dilute to 25.0 mL with the same solvent. Examine within 30 min of preparing the solution.
Reducing substances: to pass the test.
Impurity B: To pass the test by Liquid chromatography. --- 0.2 per cent.
Related substances: To pass the test by Liquid chromatography.
Storage: Under an inert gas, 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.

Ergocalciferol FCC Food Grade Specifications
Vitamin D2
Ergocalciferol; Vitamin D
C28H44O --- Formula weight 396.66
CAS 50-14-6

DESCRIPTION
Vitamin D2 occurs as white crystals. It is affected by air and by light. It is insoluble in water, but it is soluble in alcohol, in chloroform, in ether, and in fatty oils.
Function: Nutrient.

REQUIREMENTS
Identification:
A. To pass the chromatographic test.
B. The infrared absorption spectrum of a potassium bromide dispersion of the sample, in the range of 2 to 12 µm, exhibits maxima only at the same wavelengths as those of a similar preparation of USP Ergocalciferol Reference Standard.
C. The ultraviolet absorption spectrum of the sample in alcohol solution exhibits inflections at the same wavelengths as that of USP Ergocalciferol Reference Standard, similarly measured, and the respective absorptivities at 265 nm do not differ by more than 3.0%.

Assay: Not less than 97.0% and not more than 103.0% of C28H44O.
Ergosterol: Passes test.
Melting Range: Between 115° and 119°.
Optical (Specific) Rotation [α]D25°: Between +103° and +106°.
Reducing Substances: Passes test.

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

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Ergocalciferol or Vitamin D2 or Calciferol SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 15-Mar-24

Product Name & Other Names: Ergocalciferol or Vitamin D2 or Calciferol.
CAS No.: 50-14-6
EINECS EC No.: 200-014-9
Molecular Formula: C28H44O
Molecular Weight: 396.66
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 3), H301
Acute toxicity, Dermal (Category 3), H311
Acute toxicity, Inhalation (Category 2), H330
Specific target organ toxicity - repeated exposure, Oral (Category 1), H372

Hazard statements:
H301: Toxic if swallowed.
H311: Toxic in contact with skin.
H330: Fatal if inhaled.
H372 Causes damage to organs through prolonged or repeated exposure if swallowed.

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: Ergocalciferol or Vitamin D2 or Calciferol.
CAS No.: 50-14-6
EINECS EC No.: 200-014-9

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. 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. 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: White or slightly yellowish, crystalline powder or white or almost white crystals..
Odor: Not applicable.
Odor threshold: Not applicable.
pH: Not available.
Relative density: Not available.
Boiling Point: Not available.
Melting Point: 115C to 119C.
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: C28H44O
Molecular Weight: 396.66

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.
Conditions to Avoid: Incompatibles, heat flame & light.

Fatal if inhaled, swallowed and in skin contact.
LD50 Oral - Rat – 10 mg/kg.
Carcinogenicity: No information found.
Epidemiology: No information found.
Teratogenicity: No information found.
Reproductive Effects: No information found.
Mutagenicity: No information found.
Neurotoxicity: No information found.

Environmental Toxicity: No information found.
Environmental Fate: Not available.
Mobility: Not available.
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. (ergocalciferol; Vitamin D2).
Hazard Class: 6.1, Packing Group: II.
UN Number: UN2811
IATA & IMDG/IMO:
Shipping Name: Toxic solid, organic. (ergocalciferol; Vitamin D2).
Hazard Class: 6.1, Packing Group: II.

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:
H301: Toxic if swallowed.
H311: Toxic in contact with skin.
H330: Fatal if inhaled.
H372 Causes damage to organs through prolonged or repeated exposure if swallowed.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard symbols:
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.

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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