Vitamin A or Retinol BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Vitamin A or Retinol, 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 etc.

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Vitamin A or Retinol CAS Number 68-26-8, EINECS EC Number: 200-683-7, Molecular Formula: C20H30O, Molecular Weight: 286.46, HS Code 25998401 or 29362100 or 29369000

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Vitamin A or Retinol.

Vitamin A is a fat-soluble vitamin and an essential nutrient for animals. Vitamin A it has multiple functions.

Vitamin A BP Ph Eur Grade Specifications:
In the British Pharmacopoeia, the term ‘Retinol’ is used within titles for preparations containing synthetic ester(s) and the term ‘Vitamin A’ within the title for the preparation containing material of natural origin.

DEFINITION
Vitamin A Refers to a number of substances of very similar structure (including (Z)-isomers) found in animal tissues and possessing similar activity. The principal and biologically most active substance is all-(E)-retinol (all-(E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraen-1-ol; C20H30O). Vitamin A is generally used in the form of esters such as the acetate, propionate and palmitate.
Synthetic retinol ester Refers to an ester (acetate, propionate or palmitate) or a mixture of synthetic retinol esters.
The activity of vitamin A is expressed in retinol equivalents (R.E.). 1 mg R.E. corresponds to the activity of 1 mg of all-(E)-retinol. The activity of the other retinol esters is calculated stoichiometrically, so that 1 mg R.E. of vitamin A corresponds to the activity of:
- 1.147 mg of all-(E)-retinol acetate,
- 1.195 mg of all-(E)-retinol propionate,
- 1.832 mg of all-(E)-retinol palmitate.
International Units (IU) are also used to express the activity of vitamin A. 1 IU of vitamin A is equivalent to the activity of 0.300 µg of all-(E)-retinol. The activity of the other retinol esters is calculated stoichiometrically, so that 1 IU of vitamin A is equivalent to the activity of:
- 0.344 µg of all-(E)-retinol acetate,
- 0.359 µg of all-(E)-retinol propionate,
- 0.550 µg of all-(E)-retinol palmitate,
1 mg of retinol equivalent is equivalent to 3333 IU.

CHARACTERS
Appearance: Retinol acetate: pale-yellow crystals (mp: about 60C). Once melted retinol acetate tends to yield a supercooled melt.
Retinol propionate: reddish-brown oily liquid.
Retinol palmitate: a fat-like, light yellow solid or a yellow oily liquid, if melted (mp: about 26C).
Solubility: All retinol esters are practically insoluble in water, soluble or partly soluble in anhydrous ethanol and miscible with organic solvents.Vitamin A and its esters are very sensitive to the action of air, oxidising agents, acids, light and heat.

A. Thin-layer chromatography: To pass the test.
B. Related substances: To pass the test.
Retinol: To pass the test by thin-layer chromatography
Related substances: To pass the test by Ultraviolet and visible absorption spectrophotometry.

STORAGE
In an airtight container, protected from light. Once the container has been opened, its contents are to be used as soon as possible; any part of the contents not used at once should be protected by an atmosphere of inert gas.

DEFINITION
Vitamin A contains a suitable form of retinol (C20H30O; vitamin A alcohol) and possesses vitamin A activity equivalent to NLT 95.0% of that declared on the label. It may consist of retinol or esters of retinol formed from edible fatty acids, principally acetic and palmitic acids. It may be diluted with edible oils; or it may be incorporated in solid, edible carriers, or excipients; and it may contain suitable antimicrobial agents, dispersants, and antioxidants.

IDENTIFICATION
A. Color Reaction with Antimony III
Sample solution: Equivalent to 6 µg/mL of retinol in chloroform.
Analysis: To 1 mL of the Sample solution add 10 mL of antimony trichloride.
Acceptance criteria: A transient blue color appears at once.
B. Thin-Layer Chromatography: To pass the test.
Absorbance Ratio: To meet the requirement.
Packaging and Storage: Preserve in tight containers, preferably under an atmosphere of an inert gas, protected from light.

DESCRIPTION
Vitamin A occurs as a light yellow to red oil that may solidify on refrigeration (liquid form). In solid form it may have the appearance of the diluent that has been added to it. It is a suitable form or derivative of retinol (C20H30O; Vitamin A alcohol). It usually consists of retinol or esters of retinol formed from edible fatty acids, principally acetic and palmitic acids, or mixtures of these. It may be diluted with edible oils, or it may be incorporated in solid edible carriers, extenders, or excipients. It may contain suitable preservatives, dispersants, and antioxidants, providing it is not to be used in foods in which such substances are prohibited. In liquid form it is very soluble in chloroform and in ether, it is soluble in absolute alcohol and in vegetable oils, but it is insoluble in glycerin and in water. In solid form it may be dispersible in water. It is unstable in air and light.
Function: Nutrient.
Identification:
A. Dissolve an amount of sample equivalent to about 6 µg of retinol in 1 mL of chloroform, and add 10 mL of antimony trichloride. A transient blue color appears at once.
B. Assemble an apparatus for Thin-Layer Chromatography, using chromatographic silica gel as the adsorbent and a 4:1 mixture of cyclohexane:ether as the solvent system. Prepare a Standard Solution by dissolving the contents of 1 capsule of USP Vitamin A Reference Standard in sufficient chloroform to make 25.0 mL.

If the sample is in liquid form, dissolve a volume representing approximately 15,000 International Units in sufficient chloroform to make 10 mL of Sample Solution. If the sample is in solid form, weigh a quantity representing approximately 15,000 International Units, place in a separator, add 75 mL of water, heat, if necessary, to dissolve the carrier, and cool. Shake vigorously for 1 min, extract with 10 mL of chloroform by shaking for 1 min, and centrifuge to clarify the chloroform extract.
At the starting point of the chromatogram, apply 0.015 mL of the Standard Solution and 0.01 mL of the Sample Solution. Develop the chromatogram in the chromatographic chamber lined with filter paper dipping into the solvent mixture. When the solvent has ascended 10 cm, remove the plate, allow it to dry in air, and spray it with antimony trichloride. The blue spot formed is indicative of the presence of retinol. The approximate Rf values of the predominant spots, corresponding to the different forms of retinol, are 0.1 for the alcohol, 0.45 for the acetate, and 0.7 for the palmitate.

Assay: Not less than 95.0% and not more than 100.5% of the Vitamin A activity declared on the label.
Absorbance Ratio: (corrected/observed at 325 nm) Not less than 0.85.
Lead: Not more than 2 mg/kg.

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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Vitamin A or Retinol SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 18-Mar-24

Product Name & Other Names: Vitamin A or Retinol.
CAS Number: 68-26-8
EINECS EC Number: 200-683-7
Molecular Formula: C20H30O
Molecular Weight: 286.46
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per the letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Skin sensitization (Category 1), H317
Eye irritation, (Category 2) H319
Reproductive toxicity (Category 1B), H360

Hazard statements:
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
H360: May damage fertility. May damage the unborn child.

Precautionary statements:
P261: Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P262: Do not get in eyes, on skin, or on clothing.
P264 Wash skin 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.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with soap and water.
P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/ attention.

Classification according to European Directive 67/548/EEC as amended:
Hazard symbols:
Xn Harmful
Xi Irritant.
Risk-phrases:
R36 = Irritating to eyes.
R21 Harmful by in contact with skin.
R61 = May cause harm to the unborn child.

Product Name & Other Names: Vitamin A or Retinol.
CAS Number: 68-26-8
EINECS EC Number: 200-683-7

Eye Contact: Do not allow victim to rub eye (s). Let the eye (s) water naturally for a few minutes. If particle/dust does not dislodge, flush with lukewarm, gently flowing water for 5 minutes or until particle/dust is removed, while holding eyelid (s) open. If irritation persists, obtain medical attention. DO NOT attempt to manually remove anything stuck to the eye.
Skin Contact: Remove contaminated clothing, shoes, and leather goods (e.g., watchbands, belts). Quickly and gently blot or brush away excess chemicals. Wash gently and thoroughly with lukewarm gently flowing water and non-abrasive soap for 5 minutes. If irritation persists, repeat flushing. Obtain medical advice. Completely decontaminate clothing, shoes and leather goods before reuse or else discard.
Inhalation: If symptoms are experienced, remove source of contamination or move victim to fresh air. Obtain medical advice.
Ingestion: Never give anything by mouth if victim is rapidly losing consciousness or is unconscious or convulsing. Have the victim rinse their mouth thoroughly with water. DO NOT INDUCE VOMITING. Have the victim drink 2 – 8 oz. (60 – 240 ml) of water.

Fire and Explosion Hazards: Not a fire hazard. It may burn at high temperature
Extinguishing Media: Use means of extinction appropriate for the surrounding fire conditions such as water spray, carbon dioxide, dry chemical, or foam.
Fire Fighting: Apart from oxides of carbon, oxides, fumes may result from combustion. As with any fire, fire-fighters should be fully trained and wear full protective clothing including an approved, self-contained breathing apparatus which supplies a positive air pressure within a full-face piece mask. Do not use water directly on material. Do not allow water run-off to enter sewers or watercourses. Use water spray to cool unopened containers. 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.

Procedures for Cleanup: Stop release, if possible, to do so safely. Contain spill, isolate hazard area, and deny entry. Sweep up or vacuum. Place contaminated material in suitable, labeled containers for final disposal. Dispose of waste material consistent with the requirements of waste disposal authorities.
Personal Precautions: Gloves and coveralls or other protective clothing are recommended for persons responding to an accidental release. Close-fitting safety goggles may be necessary in some circumstances to prevent eye contact.
Environmental Precautions: Contamination of soil and water should be prevented. Keep spillage from entering soil, streams, or sewers.

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.
Conditions for safe storage, including any incompatibilities: Keep away from sources of ignition - No smoking. Take measures to prevent the build-up of electrostatic charge. 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. generating dust and the release of dust into the workplace. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Do not store with incompatible materials like oxidizing agents, strong acids, and strong bases.

Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
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: Light yellow to red oil or solid.
Odor: Not available.
Odor threshold: Not available.
pH in 1 % solution: Not available.
Relative density: Not available.
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
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(ies): Insoluble in water.
Viscosity: Not available.
Molecular Formula: C20H30O
Molecular Weight: 286.46

Stability and Reactivity: Stable and not considered reactive under recommended temperatures and pressures. Hazardous polymerization or runaway reactions will not occur. Dust can form an explosive mixture with air. Fine dust dispersed in air
Incompatibilities: Oxidizing agents. Avoid excessive heat. Free alcohol is sensitive to air-oxidation, but oil solutions of it are quite stable; UV light inactivates Vitamin A.
Hazardous Decomposition Products: High temperature operations will generate carbon oxides and fumes.

Acute Toxicity (Oral LD50): 2000 mg/kg Rat.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Teratogenic Effects: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: May damage the unborn child. May damage fertility.

Ecotoxicity:
Toxicity to fish: LC50: 316.23 mg/L, 96h static (Danio rerio).
Persistence and Degradability: No data available.
Mobility: No data available.
Bioaccumulation/ Accumulation: No data available.
Results of PBT and vPvB assessment: No data available for assessment.

Do not wash the material down drain. Put uncontaminated material back into the process if possible. Place contaminated material in suitable, labeled containers for disposal. Dispose of waste material consistent with the requirements of waste disposal authorities.

DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IATA/ICAO: Not regulated.
IMDG/IMO: Not regulated.

USA Regulations:
SARA 311/312 Hazards: Acute Health Hazard. Chronic Health Hazard. See section 2.

Hazard statements:
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
H360: May damage fertility. May damage the unborn child.

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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