Biotin or D-Biotin or Bios II or Coenzyme R or Vitamin B7 or Vitamin H USP BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Biotin or D-Biotin or Bios II or Coenzyme R or Vitamin B7 or Vitamin H, 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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Biotin or D-Biotin or Bios II or Coenzyme R or Vitamin B7 or Vitamin H CAS Number 58-85-5, EINECS EC Number: 200-399-3, Molecular Formula: C10H16N2O3S, Molecular Weight: 244.32, HS Code 29362950

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

General Properties and Specifications of Biotin or D-Biotin:
Appearance: White crystalline powder.
Assay: 99% minimum.
Melting Point: 229C to 231C.
Specific rotation: +89° to +93° (C=1 , 0.1N NaOH)
Storage: 2C to 8°C (Refrigerate).

Biotin USP Grade Specifications:
C10H16N2O3S -- 244.31
1H -Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, [3aS -(3aα,4β,6aα)]-;
(3aS ,4S ,6aR)-Hexahydro-2-oxo-1H -thieno[3,4-d]imidazole-4-valeric acid CAS 58-85-5
UNII: 6SO6U10H04

DEFINITION
Biotin contains NLT 97.5% and NMT 102.0% of biotin (C10H16N2O3S).

IDENTIFICATION
A. Infrared Absorption.
B. It meets the requirements in Specific Tests for Optical Rotation 〈781S〉, Specific Rotation.
C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Related Compounds: To pass the test by chromatography.
Optical Rotation, Specific Rotation: for 20 mg/mL in 0.1 N sodium hydroxide +89° to +93°

Biotin BP Ph Eur Grade Specifications:
C10H16N2O3S --- 244.3 CAS 58-85-5
Action and use: Vitamin.

DEFINITION
Biotin contains not less than 98.5 per cent and not more than the equivalent of 101.0 per cent of 5-[(3aS,4S,6aR)-2-oxohexahydrothieno[3,4-d]imidazol-4-yl]pentanoic acid, calculated with reference to the dried substance.

CHARACTERS
A white or almost white, crystalline powder or colourless crystals, very slightly soluble in water and in alcohol, practically insoluble in acetone. It dissolves in dilute solutions of alkali hydroxides.

IDENTIFICATION
First identification: A
Second identification: B, C
A. Examine by infrared absorption spectrophotometry, comparing with the spectrum obtained with biotin CRS.
B. Examine the chromatograms obtained in the test for related substances (see Tests). The principal spot in the chromatogram obtained with test solution (b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution (a).
C. Dissolve about 10 mg in 20 mL of water with heating. Allow it to cool. Add 0.1 mL of bromine water. The bromine water is decolourised.

TESTS
Solution S: Dissolve 0.250 g in a 4 g/L solution of sodium hydroxide and dilute to 25.0 mL with the same alkaline solution.
Appearance of solution: Solution S is clear and colourless.
Specific optical rotation: The specific optical rotation is + 89 to + 93, determined on solution S and calculated with reference to the dried substance.
Related substances: To pass the test.
Loss on drying: Not more than 1.0 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Not more than 0.1 per cent, determined on 1.0 g.

Biotin FCC Food Grade Specifications:
cis-Hexahydro-2-oxo-1H-thieno[3,4]imidazole-4-valeric
Acid; d-Biotin
C10H16N2O3S Formula weight 244.31
CAS 58-85-5

DESCRIPTION
Biotin occurs as a practically white, crystalline powder. It is stable to air and heat. One-gram dissolves in about 5000 mL of water at 25C and in about 1300 mL of alcohol; it is more soluble in hot water and in dilute alkali, and it is insoluble in other common organic solvents.
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.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Biotin or D-Biotin or Bios II or Coenzyme R or Vitamin B7 or Vitamin H
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 26-Oct-23

Product Name & Other Names: Biotin or D-Biotin or Bios II or Coenzyme R or Vitamin B7 or Vitamin H.
CAS Number: 58-85-5
EINECS EC Number: 200-399-3
Molecular Formula: C10H16N2O3S
Molecular Weight: 244.32
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)

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352 - IF ON SKIN: Wash with plenty of soap and water.
P304 + P340 - 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+313: If eye irritation persists get medical advice/attention.

Product Name & Other Names: Biotin or D-Biotin or Bios II or Coenzyme R or Vitamin B7 or Vitamin H.
CAS Number: 58-85-5
EINECS EC Number: 200-399-3

Always get medical attention after the first aid is over.
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.

Extinguisher Media: Use media suitable to extinguish surrounding fire. Water. Foam. Dry chemical or CO2. Oxides of Carbon, Sulfur, and Nitrogen may arise on decomposition.
Flammable Limits in Air % by Volume: N/A
Special Firefighting Procedures: Firefighters should wear full protective equipment and NIOSH approved self-contained breathing apparatus. Use water spray to cool unopened containers.
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: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. 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.
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. Store protected from 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 strong oxidizing agents. Storage: 2C to 8°C (Refrigerate).

Exposure Guidelines: This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Respiratory Protection (Specify Type): None needed under normal conditions of use with adequate ventilation. NIOSH approved equipment should be worn if PELs are exceeded.
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 and Odor: White crystalline powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting point/freezing point: 229C to 231C.
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 in Water: Soluble in water.
Viscosity: Not available.
Molecular Formula: C10H16N2O3S
Molecular Weight: 244.32

Stability: Stable under ordinary conditions.
Conditions to Avoid: Heat, humidity, sunlight, strong oxidizing agents.
Incompatibility (Materials to Avoid): Strong oxidizing agents.
Hazardous Decomposition Products: Fumes, Carbon, Sulfur, and Nitrogen oxides.
Hazardous Polymerization: Will not occur.

Toxicity to Animals:
LD50 Oral - Rat - > 2000 mg/kg.
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: No information available.

Toxicity to fish: No data available.
Persistence and Degradability: Unlikely to persist due to water solubility.
Mobility: Likely to be mobile due to water solubility.
Bioaccumulation/ Accumulation: Will not accumulate.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal Methods: Dispose in accordance with all applicable Federal, State and Local regulations.

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

USA:
SARA 311/312 Hazards: No SARA Hazards. See section 2.
California Prop. 65 Components: This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.

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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