D-Biotin, also called vitamin B7, 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.
Result
White crystalline power.
- Solubility
Slightly soluble in water and alcohol, practically insoluble in acetone.
Result
Complies
- Identification By IR
To match with the reference IR spectrum
Result
Complies
- Identification Test B by optical Rotation
It meets the requirements in Specific Tests for Optical Rotation, Specific Rotation
Result
Complies
- Clear and Color
0.01g/ml solution (in 4 g/1 NaOH) is clear and colorless
Result
Complies
- Sulphated Ash
NMT 0.1 %
Result
Complies
- Specific optical Rotation
+89° ~ +93°
Result
10.0 ml
- Heavy Metal
NMT 10 ppm
Result
10.0 ml
- Loss on drying
NMT 0.1 %
Result
10.0 ml
- Related Substances by HPLC
Result10.0 ml
- Individual Impurities
NMT 1.0 %
Result
10.0 ml
- Total Impurities
NMT 2.0 %
Result
10.0 ml
- Assay by Titration
NLT 98.5 & NMT 101 %
Result
10.0 ml
- Assay by HPLC
NLT 97.5 & NMT 102 %
Result
10.0 ml
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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.
