Impurity reference standards

Biotin impurity standards

This page brings together 14 Biotin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 5 pharmacopoeial impurities and 1 nitrosamine.

14reference materials

5pharmacopoeial

1nitrosamines

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities

Nitrosamines1N-nitroso impurities for ICH M7 work

Counts are based on product names. One compound can fall into more than one type.

All Biotin reference materials

1–14 of 14 standards

(-)-Biotin Sulfoxide

CAS: 3376-83-8
Formula: C₁₀H₁₆N₂O₄S
MW: 260.31 g/mol

ZX-028280

(+)-Biotin (+)-Sulfoxide

CAS: 10406-89-0
Formula: C₁₀H₁₆N₂O₄S
MW: 260.31 g/mol

ZX-023586

(S)-5-Oxo-3-thiomorpholinecarboxylic acid methyl ester

CAS: 118903-82-5
Formula: C₆H₉NO₃S
MW: 175.21 g/mol

ZX-044720

1`N-Benzyl Biotin

CAS: 76335-62-1
Formula: C₁₇H₂₂N₂O₃S
MW: 334.4 g/mol

ZX-028279

3N-Benzyl Biotin

CAS: 57229-92-2
Formula: C₁₇H₂₂N₂O₃S
MW: 334.4 g/mol

ZX-020875

Biotin EP Impurity A

CAS: 1163708-46-0
Formula: C₁₈H₂₈N₄O₄S₂
MW: 428.6 g/mol

ZX-020879

Biotin EP Impurity B

CAS: 57671-79-1
Formula: C₁₁H₁₆N₂O₅S
MW: 288.32 g/mol

ZX-020878

Biotin EP Impurity C

CAS: 22342-46-7
Formula: C₉H₁₈N₂O₂S
MW: 218.32 g/mol

ZX-020877

Biotin EP Impurity D

CAS: 415725-35-8
Formula: C₁₁H₁₈N₂O₃S
MW: 258.34 g/mol

ZX-020880

Biotin EP Impurity F

CAS: 101469-35-6
Formula: C₂₉H₃₆N₂O₅S
MW: 524.7 g/mol

ZX-020881

Biotin Sulfone

CAS: 40720-05-6
Formula: C₁₀H₁₆N₂O₅S
MW: 276.31 g/mol

ZX-020876

Biotinyl-GHK tripeptide

CAS: 299157-54-3
Formula: C₂₄H₃₈N₈O₆S
MW: 566.7 g/mol

ZX-031441

Nitrosobiotin

CAS: 56859-26-8
Formula: C₁₀H₁₅N₃O₄S
MW: 273.31 g/mol

ZX-023587

Sulfo-NHS-Biotin

CAS: 119616-38-5
Formula: C₁₄H₁₈N₃NaO₈S₂
MW: 443.4 g/mol

ZX-044740

Questions

Biotin impurities, answered

What Biotin reference materials are available?

The catalogue currently lists 14 compounds for Biotin, including 5 pharmacopoeial impurities and 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.

What documents come with a Biotin impurity standard?

A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.

Can Zemixal make a Biotin impurity that is not listed?

Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.

Do you supply Biotin nitrosamine impurities?

Yes. 1 N-nitroso compound is listed for Biotin. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

Nearby APIs in the index

Bioallethrin 2 Biotin Hydrazide 1 All APIs