D-Biotin, also called vitamin B?, is one of the B vitamins. It is involved in a wide range of metabolic processes, both in humans and in other organisms, primarily related to the utilization of fats, carbohydrates, and amino acids. The name biotin derives from the Greek word “bios” and the suffix “-in”.

 

Certificate of Analysis

• Appearance

  White or off – white crystalline powder.

• Solubility

  Slightly soluble in water and alcohol, practically insoluble in acetone.

• Identification By IR

  To match with the reference IR spectrum

• Identification Test B by optical Rotation

  It meets the requirements in Specific Tests for Optical Rotation, Specific Rotation

• Clear and Color

  0.01g/ml solution (in 4 g/1 NaOH) is clear and colorless

• Sulphated Ash

  NMT 0.1 %

• Specific optical Rotation

  +89° ~ +93°

• Heavy Metal

  NMT 10 ppm

• Loss on drying

  NMT 0.1 %

• Related Substances by HPLC

• Individual Impurities

  NMT 1.0 %

• Total Impurities

  NMT 2.0 %

• Assay by Titration

  NLT 98.5 & NMT 101 %

• Assay by HPLC

  NLT 97.5 & NMT 102 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  D-Biotin

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  D-Biotin

  Chemical Name

  D-Biotin, Vitamin H, Vitamin B7

  EINECS #

  200-399-3

  Synonym

  D-Biotin, Vitamin H, Vitamin B7

  Molecular Formula

  C10H16N2O3S

  Molecular Weight

  244.31 g/mol

  CAS

  58-85-5

• Section 3 – HAZARDOUS IDENTIFICATION

  Classification of the substance or mixture

   .

  Classification according to Regulation (EC) No 1272/2008

  Eye irritation (Category 2), H319. For the full text of the H-Statements mentioned in this Section, see Section 16.

  Label elements

  Hazard statement(s)

  Precautionary statement(s)Supplemental Hazard

  Other hazards

  None

• Section 4 – FIRST AID

  General advice

  Show this material safety data sheet to the doctor in attendance.

  If inhaled

  If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.

  In case of skin contact

  Wash off with soap and plenty of water. Take victim immediately to hospital. Consult a physician.

  In case of eye contact

  Flush eyes with water as a precaution

  If swallowed

  Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

  Most important symptoms and effects, both acute and delayed

  The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section 11

  Indication of any immediate medical attention and special treatment needed

  N/A

• Section 5 – FIRE FIGHTING MEASURES

  Extinguishing media

  Suitable extinguishing media

  Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

  Special hazards arising from the substance or mixture

  Carbon oxides, Nitrogen oxides (NOx), Sulfur oxides

  Special hazards arising from the substance or mixture

  Carbon oxides, Nitrogen oxides (NOx), Sulfur oxides Combustible. Development of hazardous combustion gases or vapours possible in the event of fire.

  Advice for firefighters

  Wear self-contained breathing apparatus for firefighting if necessary.

  Further information

  N/A

• Section 6 – ACCIDENT RELEASE MEASURES

  Personal precautions, protective equipment and emergency procedures

  Wear respiratory protection. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. For personal protection see section 8.

  Environmental precautions

  Do not let product enter drains.

  Methods and materials for containment and cleaning up

  Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.

  Reference to other sections

  For disposal see section 13.

• Section 7 – HANDLING AND STORAGE

  Precautions for safe handling

  Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed. For precautions see section 2.2.

  Conditions for safe storage, including any incompatibilities

  Dry, Seal place.

  Specific end use(s)

  Apart from the uses mentioned in section 1.2 no other specific uses are stipulated.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Control parameters

  Ingredients with workplace control parameters.

  Appropriate engineering controls

  Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

  Eye/face protection

  Face shield and safety glasses Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).

  Skin protection

  Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove’s outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

  Body Protection

  Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.

  Respiratory protection

  For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator. For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure.

  Control of environmental exposure

  Do not let product enter drains.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical state and appearance

  White to light yellow powder

  pH

  N/A

  Melting Point

  231-233 °C(lit.)

  Boiling point

  N/A

  Autoignition Temperature

  N/A

  Flash Point

  N/A

  Explosion Limits

  N/A

  Decomposition Temperature

  N/A

  Solubility in water

  N/A

  Specific Gravity/Density

  N/A

  Other safety information

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Reactivity

  N/A

  Chemical stability

  Stable under recommended storage conditions.

  Possibility of hazardous reactions

  N/A

  Conditions to avoid

  Avoid moisture.

  Incompatible materials

  Acids, Acid chlorides, Acid anhydrides, Oxidizing agents

  Hazardous decomposition products

  Other decomposition products – no data available. In the event of fire: see section 5

• Section 11 – TOXICOLOGICAL INFORMATION

  Information on toxicological effects

  Acute toxicity

  N/A

  Skin corrosion/irritation

  N/A

  Serious eye damage/eye irritation

  N/A

  Respiratory or skin sensitization

  Prolonged or repeated exposure may cause allergic reactions in certain sensitive individuals. The preceding data, or interpretation of data, was determined using Quantitative Structure Activity Relationship (QSAR) modeling.

  Germ cell mutagenicity

  N/A

  Carcinogenicity

  IARC

  No ingredient of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.

  Reproductive toxicity

  N/A

  Specific target organ toxicity – single exposure

  Inhalation

  May cause respiratory irritation.

  Specific target organ toxicity – repeated exposure

  N/A

  Aspiration hazard

  N/A

  Additional Information

  RTECS

  Not available To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.

• Section 12 – ECOLOGICAL INFORMATION

  Toxicity

  N/A

  Persistence and degradability

  N/A

  Bioaccumulative potential

  N/A

  Mobility in soil

  N/A

  Results of PBT and vPvB assessment

  PBT/vPvB assessment not available as chemical safety assessment not required/not conducted.

  Other adverse effects

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste treatment methods

  Product

  Burn in a chemical incinerator equipped with an afterburner and scrubber but exert extra care in igniting as this material is highly flammable. Offer surplus and nonrecyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material.

  Contaminated packaging

  Dispose of as unused product.

• Section 14 – TRANSPORT INFORMATION

  DOT (US)

  Not dangerous goods

  IMDG

  Not dangerous goods

  IATA

  Not dangerous goods

• Section 15 – REGULATORY INFORMATION

  This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.

  N/A

  Chemical Safety Assessment

  For this product a chemical safety assessment was not carried out.

• Section 16 – OTHER INFORMATION

  Global Pharma provides information contained herein in good faith but makes no representation as to its comprehensives or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product.

  Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

  GLOBAL PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OR MERCHANTABILITY, FITNESS FOR A PARTICULER PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT WHICH THE INFORMATION REEFERS. GLOBAL PHARMA WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF RELIANCE UPON THIS INFORMATION.