Biotin CAS 58-85-5 Assay 97.5~100.5% Factory

Short Description:

Chemical Name: Biotin

Synonyms: D-Biotin; Vitamin H; Vitamin B7

CAS: 58-85-5

Assay: 97.5~100.5%

White or Almost White Crystalline Powder 

Contact: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com


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Description:

Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer of Biotin (Vitamin H) (CAS: 58-85-5) with high quality. Ruifu Chemical can provide worldwide delivery, competitive price, excellent service, small and bulk quantities available. Purchase Biotin (CAS: 58-85-5), Please contact: alvin@ruifuchem.com

Chemical Properties:

Chemical Name Biotin 
Synonyms D-Biotin; D(+)-Biotin; Vitamin H; Bios II; Vitamin B7; Coenzyme R; Biotinum
Stock Status In Stock, Commercial Production  
CAS Number 58-85-5
Molecular Formula C10H16N2O3S 
Molecular Weight 244.31 g/mol
Melting Point 231.0~233.0℃(lit.) 
Water Solubility  Slightly Soluble in Water 
Solubility in 0.1mol/L NaOH  Almost Transparency  
Solubility Slightly Soluble in Alcohol, Chloroform, Ether
COA & MSDS Available
Origin Shanghai, China
Brand Ruifu Chemical

Specifications:

Items Specifications Results
Appearance White or Almost White Crystalline Powder  White Crystalline Powder 
Identification IR Match with the Reference IR Spectrum  Complies 
Retention Time Should be similar to that of the RS  Complies 
Specific Rotation [a]20/D +89.0° to +93.0° (C=2 in 0.1 M NaOH)  +90.8°
Assay 97.5~100.5% 99.8%
Loss on Drying <0.50% 0.05%
Related Substances
Individual Impurity <1.00% Complies 
Total Impurities <2.00% Complies 
Residual Solvents    
Benzene <2ppm <0.2ppm
Toluene <100ppm <10ppm
DMSO <5000ppm <500ppm
Microbial Test    
Total Viable Aerobic Count ≤1000cfu/g Complies  
Total Yeasts and Moulds Count ≤100cfu/g Complies  
Escherichia Coli N.D./1g /
Staphylococcus Aureus N.D./1g /
Pseudomonas Aeruginosa N.D./1g /
Enterobacteria N.D./1g /
Salmonella Species N.D./10g /
Conclusion The product has been tested and complies with the given specifications

Package/Storage/Shipping:

Package: Fluorinated Bottle, Aluminium foil bag, 25kg/Cardboard Drum, or according to customer's requirement.
Storage Condition: Keep the container tightly closed and store in a cool, dry (2~8℃) and well-ventilated warehouse away from incompatible substances. Protect from light and moisture.
Shipping: Deliver to worldwide by air, by FedEx / DHL Express. Provide fast and reliable delivery. 

58-85-5 - USP 35 Standard:

DEFINITION Analysis Biotin contains NLT 97.5% and NMT 100.5% of Biotin (C10H16N2O3S).
IDENTIFICATION
• A. INFRARED ABSORPTION <197K>
B. It meets the requirements in Specific Tests for Optical Rotation, Specific Rotation <781S>.
C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• PROCEDURE
Buffer solution: Dissolve 1 g of sodium perchlorate monohydrate in 500 mL of water, add 1 mL of phosphoric acid, and dilute with water to 1000 mL
Mobile phase: Acetonitrile and Buffer solution (8.5: 91.5)
Diluent: Acetonitrile and water (1:4)
Standard solution: 0.1 mg/mL of USP Biotin RS in Diluent. Sonicate if necessary to dissolve
Sample solution: 0.1 mg/mL of Biotin in Diluent. Sonicate if necessary to dissolve.
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 200 nm
Column: 4.6-mm × 15-cm; 3-µm packing L7
Flow rate: 1.2 mL/min
Injection size: 50 µL
System suitability
Sample: Standard solution
Suitability requirements
Tailing factor: NMT 1.5
Relative standard deviation: NMT 2.0% for replicate injections
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of Biotin (C10H16N2O3S) in the portion of Biotin taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response from the Sample solution
rS = peak response from the Standard solution
CS = concentration of USP Biotin RS in the Standard solution (mg/mL)
CU = concentration of Biotin in the Sample solution (mg/mL)
Acceptance criteria: 97.5%-100.5%
IMPURITIES
• RELATED COMPOUNDS
Buffer solution, Mobile phase, Diluent, Standard solution, Sample solution, Chromatographic system and System suitability: Proceed as directed in the Assay.
Analysis
Sample: Sample solution
Measure the peak responses of the Sample solution.
Calculate the percentage of each impurity in the portion of Biotin taken:
Result = (rU/rT) × 100
rU = peak response of each impurity from the Sample solution
rT = sum of the peak responses of all the peaks from the Sample solution
Acceptance criteria
Individual impurity: NMT 1.0%
Total impurities: NMT 2.0%
SPECIFIC TESTS
• OPTICAL ROTATION, Specific Rotation <781S>
Sample solution: 20 mg/mL in 0.1 N sodium hydroxide
Acceptance criteria: +89° to +93°
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Store in tight containers.
• USP REFERENCE STANDARDS <11>
USP Biotin RS

Advantages:

Sufficient Capacity: Sufficient facilities and technicians

Professional Service: One stop purchasing service

OEM Package: Custom package and label available

Fast Delivery: If within stock, three days delivery guaranteed

Stable Supply: Maintain reasonable stock    

Technical Support: Technology solution available

Custom Synthesis Service: Ranged from grams to kilos

High Quality: Established a complete quality assurance system

FAQ:

How to Purchase? Please contact Dr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com 

15 Years Experience? We have more than 15 years of experience in the manufacture and export of a wide range of high quality pharmaceutical intermediates or fine chemicals.

Main Markets? Sell to domestic market, North America, Europe, India, Korea, Japanese, Australia, etc.

Advantages? Superior quality, affordable price, professional services and technical support, fast delivery.

Quality AssuranceStrict quality control system. Professional equipment for analysis include NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, K.F, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, etc.

SamplesMost products provide free samples for quality evaluation, shipping cost should be paid by customers.

Factory AuditFactory audit welcome. Please make an appointment in advance.

MOQ? No MOQ. Small order is acceptable.

Delivery Time? If within stock, three days delivery guaranteed.

TransportationBy Express (FedEx, DHL), by Air, by Sea.

Documents? After sales service: COA, MOA, ROS, MSDS, etc. can be provided.

Custom SynthesisCan provide custom synthesis services to best fit your research needs.

Payment TermsProforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T (Telex Transfer), PayPal, Western Union, etc. 

58-85-5 - Safety Information:

Hazard Symbols Xn - Harmful
Risk Codes R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed.
R36/37/38 - Irritating to eyes, respiratory system and skin.
Safety Description S24/25 - Avoid contact with skin and eyes.
S36 - Wear suitable protective clothing.
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
WGK Germany 1
RTECS XJ9088200
FLUKA BRAND F CODES 8
TSCA Yes
HS Code 2936290000
Toxicity LD50 orally in Rabbit: > 2000 mg/kg

58-85-5 - Application:

Biotin (Vitamin H; Vitamin B7) (CAS: 58-85-5)
Biotin is a water-soluble vitamin in eight forms, biotin. It is a coenzyme - or helper enzyme - used in many metabolic reactions in the body. Dchemicalbook-biotin is involved in lipid and protein metabolism, helping to convert food into glucose, which the body can use as energy. It is also important for maintaining skin, hair and mucous membranes.
As a feed additive, Biotin is mainly used for poultry and sow feed. Usually the premixed mass fraction is 1%-2%.
Biotin is nutritional supplement. According to China GB2760-90 regulations, it could be used as a food industry as a processing aid. It has physiological functions to prevent skin diseases and promote lipid metabolism and so on.
Biotin is carboxylase coenzyme, involved in many carboxylation reactions, and is an important coenzyme in the metabolism of sugar, protein and fat.
Biotin is used as food fortifier. Biotin is used for infant food with amount of 0.1~0.4mg/kg, in the drinking liquid 0.02~0.08mg/kg.
Biotin could be used for labeling proteins, antigens, antibodies, nucleic acids (DNA, RNA) and so on.
Biotin can make hair elastic, prevent early hair loss and improve the natural resistance of skin. It also have certain effectiveness of anti-wrinkle. It can enhance the overall organizational structure of the skin, increase the flexibility of nails, improve the structure of brittle nails and make nails more fine and smooth by promoting the synthesis of lipids. 

The absence of biotin may cause dermatitis, atrophic glossitis, hyperesthesia, myalgia, malaise, anorexia, and mild anemia, and the symptoms disappear with biotin supplementation. Its most common side effect is an outbreak of cystic acne. But for most people, even excessive consumption of this vitamin does not cause a negative effect. However, pregnant women should not take biotin because of the risk of miscarriage.

58-85-5 - Toxicity:

The toxicity of Biotin seems to be low, treatment of seborrheic dermatitis with high doses of Biotin did not reveal abnormal protein metabolism or genetic errors and other metabolic abnormalities. Animal experiments also showed little toxicity of Biotin. 

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