Impurity reference standards

Tacrolimus impurity standards

For Tacrolimus, the Zemixal catalogue holds 23 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 pharmacopoeial impurities, 5 metabolites or hydroxylated analogues and 1 degradation product.

23reference materials

2pharmacopoeial

5metabolites

1degradants

Parent API

Tacrolimus

CAS: 104987-11-3
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol
Code: ZX-004253

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities

Metabolites5Hydroxy, desmethyl and conjugated forms

Degradants1N-oxides, dimers, lactones and breakdown products

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

All Tacrolimus reference materials

1–23 of 23 standards

(E)-8-Ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-(4-hydroxy-3-methoxycyclohexyl)-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone

CAS: 135635-46-0
Formula: C₄₃H₆₉NO₁₂
MW: 792 g/mol

ZX-032594

13-O-Desmethyl tacrolimus

CAS: 139958-51-3
Formula: C₄₃H₆₇NO₁₂
MW: 790 g/mol

ZX-027073

16Beta Hydroxytestosterone

CAS: 17528-90-4
Formula: C₁₉H₂₈O₃
MW: 304.4 g/mol

ZX-046413

8-Epitacrolimus

CAS: 129212-35-7
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-027065

9-Norketo FK-506

CAS: 123719-19-7
Formula: C₄₃H₆₉NO₁₁
MW: 776 g/mol

ZX-027076

Androstadienone

CAS: 4075-07-4
Formula: C₁₉H₂₆O
MW: 270.4 g/mol

ZX-044884

Ascomycin

CAS: 104987-12-4
Formula: C₄₃H₆₉NO₁₂
MW: 792 g/mol

ZX-027062

Desmethyl Tacrolimus

CAS: 132172-14-6
Formula: C₄₃H₆₇NO₁₂
MW: 790 g/mol

ZX-027072

Methyl Nervonate

CAS: 2733-88-2
Formula: C₂₅H₄₈O₂
MW: 380.6 g/mol

ZX-027066

Oxacyclohexane Open Ring Tacrolimus

CAS: 144432-23-5
Formula: C₄₄H₇₁NO₁₃
MW: 822 g/mol

ZX-027070

Tacrolimus

CAS: 104987-11-3
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-004253

Tacrolimus

CAS: 104987-11-3
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-006836

Tacrolimus 19-epimer

CAS: 144490-63-1
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-027071

Tacrolimus Dehydro Impurity

CAS: 129212-37-9
Formula: C₄₄H₆₇NO₁₁
MW: 786 g/mol

ZX-027077

Tacrolimus Diene

CAS: 104987-16-8
Formula: C₄₄H₆₇NO₁₁
MW: 786 g/mol

ZX-027063

Tacrolimus EP Impurity E

CAS: 104987-30-6
Formula: C₄₄H₇₁NO₁₂
MW: 806 g/mol

ZX-027061

Tacrolimus EP Impurity H

CAS: 143210-33-7
Formula: C₄₃H₆₉NO₁₁
MW: 776 g/mol

ZX-027075

Tacrolimus Hydroxy Acid Impurity

CAS: 1700657-83-5
Formula: C₄₄H₇₁NO₁₃
MW: 822 g/mol

ZX-027064

Tacrolimus Impurity 2

CAS: 131944-48-4
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-027068

Tacrolimus Lactone Isomer

CAS: 134590-88-8
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-027069

Tacrolimus Methyl Acryl Aldehyde

CAS: 109466-74-2
Formula: C₁₁H₁₈O₃
MW: 198.26 g/mol

ZX-027067

Tacrolimus Monohydrate

CAS: 109581-93-3
Formula: C₄₄H₇₁NO₁₃
MW: 822 g/mol

ZX-027060

Tacrolimus Ring-opening Impurity

CAS: 1393890-33-9
Formula: C₄₄H₆₉NO₁₂
MW: 804 g/mol

ZX-027074

Questions

Tacrolimus impurities, answered

What Tacrolimus reference materials are available?

The catalogue currently lists 23 compounds for Tacrolimus, including 2 pharmacopoeial impurities, 5 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.

What documents come with a Tacrolimus 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 Tacrolimus 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.

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