Biotin CAS 58-85-5 Assay 97.5~100.5% Factory
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 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 |
| 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: 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.
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
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 Assurance? Strict 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.
Samples? Most products provide free samples for quality evaluation, shipping cost should be paid by customers.
Factory Audit? Factory audit welcome. Please make an appointment in advance.
MOQ? No MOQ. Small order is acceptable.
Delivery Time? If within stock, three days delivery guaranteed.
Transportation? By Express (FedEx, DHL), by Air, by Sea.
Documents? After sales service: COA, MOA, ROS, MSDS, etc. can be provided.
Custom Synthesis? Can provide custom synthesis services to best fit your research needs.
Payment Terms? Proforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T (Telex Transfer), PayPal, Western Union, etc.
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
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.
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.
