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Pharmaceutical Secondary Standard; Certified Reference Material

Bios II, Vitamin H, Vitamin B7, D-Biotin, Coenzyme R
Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


231-233 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)



pharmacopeia traceability

traceable to PhEur B1116000
traceable to USP 1071508

SMILES string




InChI key


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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Biotin is a water-soluble vitamin, essential for amino acids and carbohydrates metabolism. It is involved in de novo synthesis of purine nucleotides and plays a role in gene expression and DNA replication.


These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Biotin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical preparations using a bio-sensing system and chromatography techniques.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.


To see an example of a Certificate of Analysis for this material enter LRAC0265 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

11 - Combustible Solids



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Determination of biotin in foodstuffs and pharmaceutical preparations using a biosensing system based on the streptavidin--biotin interaction.
Reyes FD, et al.
Analytica Chimica Acta, 436(1), 109-117 (2001)
Using of HPLC coupled with coulometric detector for the determination of biotin in pharmaceuticals.
Zerzanova A, et al.
Journal of Pharmaceutical and Biomedical Analysis, 45(5), 730-735 (2007)
Liquid chromatographic determination of biotin in multivitamin-multimineral tablets.
Ekpe AE and Hazen C
Journal of Pharmaceutical and Biomedical Analysis, 16(8), 1311-1315 (1998)
Yuxi Feng et al.
PloS one, 6(2), e16865-e16865 (2011-03-08)
Vasoregression is a hallmark of vascular eye diseases but the mechanisms involved are still largely unknown. We have recently characterized a rat ciliopathy model which develops primary photoreceptor degeneration and secondary vasoregression. To improve the understanding of secondary vasoregression in...
Sung Jae Shin et al.
Clinical and vaccine immunology : CVI, 15(8), 1277-1281 (2008-06-14)
We previously reported that protein antigens of serodiagnostic potential were more abundant in culture filtrates than cellular extracts from liquid cultures of Mycobacterium avium subsp. paratuberculosis (D. Cho and M. T. Collins, Clin. Vaccine Immunol. 13:1155-1161, 2006). Based on this...


HPLC Analysis of Water-Soluble B-Vitamins on Ascentis® Express C18

Pyridoxine hydrochloride, ≥98% (HPLC); Nicotinamide, ≥98.5% (HPLC); Thiamine hydrochloride, reagent grade, ≥99% (HPLC); Biotin, ≥99.0% (T); Folic acid, analytical standard; Cyanocobalamin (B12), analytical standard; Riboflavin (B2), analytical standard

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