Everolimus Impurity Standards

Everolimus impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Everolimus-related impurities during analytical method development, method validation, and regulatory filing. As a mTOR inhibitor immunosuppressant, Everolimus requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Everolimus impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

EVEROLIMUS IMPURITY 6

Chemical Name: Rapamycin, 7-O-demethyl-42-O-(2-hydroxye...

CAS No:
408496-50-4

Molecular Formula: C52H81NO14

Molecular Weight: 944.2

CAT No:
ALL-E08715

Keywords: SMILES string - O=C(C(N1CCCC[C@@]1([H])C...

Inventory Status:IN STOCK

COA MSDS

PROLYL EVEROLIMUS

Chemical Name: PROLYL EVEROLIMUS

CAS No:
N.A.

Molecular Formula: C52H81NO14

Molecular Weight: 943.57

CAT No:
ALL-E01814

Keywords: SMILES string - OCCO[C@H]1[C@H](OC)C[C@H...

Inventory Status:IN STOCK

COA MSDS

12-ETHYL RAPAMYCIN

Chemical Name: 12-Demethyl-12-ethylrapamycin

CAS No:
1290606-20-0

Molecular Formula: C52H81NO13

Molecular Weight: 928.20

CAT No:
ALL-R03060

Keywords: 12-ETHYL RAPAMYCIN | RAPAMYCIN | EVERO...

Inventory Status:IN STOCK/ 01-198

COA MSDS

28-EPI RAPAMYCIN IMPURITY

Chemical Name: 28-EPI RAPAMYCIN

CAS No:
253431-35-5

Molecular Formula: 914.2

Molecular Weight: C51H79NO13

CAT No:
ALL-R03141

Keywords: SMILES string - O=C(C([C@](O[C@]1([H])C[...

Inventory Status:IN STOCK

COA MSDS

EVEROLIMUS

Chemical Name: Dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hy...

CAS No:
159351-69-6

Molecular Formula: C53H83NO14

Molecular Weight: 958.2

CAT No:
ALL-E03371

Keywords: SMILES string - O=C(C([C@](O[C@]1([H])C[...

Inventory Status:IN STOCK /01-260

COA MSDS

EVEROLIMUS 15-0-ETHYL IMPURITY

Chemical Name: (1R,9S,12S,15R,16E,18R,19R,21R,23S,25E,2...

CAS No:
N.A.

Molecular Formula: C54H85NO14

Molecular Weight: 972.3

CAT No:
ALL-E08715

Keywords: EVEROLIMUS 15-0-ETHYL ISOMER

Inventory Status:IN STOCK

COA MSDS

EVEROLIMUS EP IMPURITY A

Chemical Name: (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,2...

CAS No:
53123-88-9

Molecular Formula: C51H79NO13

Molecular Weight: 914.18

CAT No:
ALL-R03370

Keywords: SMILES string - O=C(O[C@@]([C@@](C)([H])...

Inventory Status:IN STOCK / 01-261

COA MSDS

EVEROLIMUS EP IMPURITY B | EVEROLIMUS-19-ENE OPEN RING

Chemical Name: (2S)-1-[2-[(2R,3R,6S)-2-hydroxy-6-[(2S,...

CAS No:
1062122-63-7

Molecular Formula: C53H83NO14

Molecular Weight: 958.22

CAT No:
ALL-EVE-2651

Keywords: SMILES string - OC([C@@]1([H])N(C(C([C@@...

Inventory Status:IN STOCK / 01-110

COA MSDS

EVEROLIMUS EP IMPURITY C

Chemical Name: (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S...

CAS No:
N.A.

Molecular Formula: C52H81NO14

Molecular Weight: 944.20

CAT No:
ALL-EVE-2652

Keywords: SMILES string - O=C(O[C@@]([C@@](C)([H])...

Inventory Status:IN STOCK / 01-109

COA MSDS

EVEROLIMUS EP IMPURITY D

Chemical Name: (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,2...

CAS No:
2760174-96-5

Molecular Formula: C53H83NO14

Molecular Weight: 958.22

CAT No:
ALL-EVE-2670

Keywords: SMILES string - O=C(O[C@@]([C@@](C)([H])...

Inventory Status:IN STOCK / 01-108

COA MSDS

EVEROLIMUS EP IMPURITY E

Chemical Name: [(1R,2R,4S)-4-[(2R)-2-[(1R,9S,12S,15R,16...

CAS No:
1237826-25-3

Molecular Formula: C52H79NO14

Molecular Weight: 942.18

CAT No:
ALL-EVE-2653

Keywords: SMILES string - O=C(O[C@@]([C@@](C)([H])...

Inventory Status:IN STOCK / 01-107

COA MSDS

EVEROLIMUS EP IMPURITY F

Chemical Name: (1R,9S,12S,15R,16E,18R,19S,20R,21R,23S,2...

CAS No:
N.A.

Molecular Formula: C55H89NO16

Molecular Weight: 1020.3

CAT No:
ALL-P03056

Keywords: SMILES string - O=C(O[C@@]([C@@](C)([H])...

Inventory Status:IN STOCK / 01-100

COA MSDS

EVEROLIMUS EP IMPURITY I

Chemical Name: Specied unidentied impurity 3

CAS No:
N.A.

Molecular Formula: N.A.

Molecular Weight: 944 / 792 (As Per Mass Spectra)

CAT No:
ALL-E02870

Keywords: Specied unidentied impurity 3

Inventory Status:IN STOCK / 01-106

COA MSDS

EVEROLIMUS EP IMPURITY J

Chemical Name: Not Available

CAS No:
N.A.

Molecular Formula: N.A.

Molecular Weight: 942.1 / 810.1 (As Per Mass Spectra)

CAT No:
ALL-E02871

Keywords: EVEROLIMUS EP IMPURITY J

Inventory Status:IN STOCK / 01-105

COA MSDS

EVEROLIMUS OPEN-RING ACID IMPURITY

Chemical Name: (2S)-1-[2-[(2R,3R,6S)-6-[(2S,3E,5E,7E,9S...

CAS No:
769905-89-7

Molecular Formula: C53H85NO15

Molecular Weight: 976.24

CAT No:
ALL-EVE-2692

Keywords: EVEROLIMUS OPEN-RING ACID IMPURITY | SEC...

Inventory Status:IN STOCK/01-259

COA MSDS

EVEROLIMUS OXEPANE ISOMER

Chemical Name: 3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,...

CAS No:
908340-97-6

Molecular Formula: C53H83NO14

Molecular Weight: 958.22

CAT No:
ALL-E03316

Keywords: SMILES string - OCCO[C@H]1[C@H](OC)C[C@@...

Inventory Status:IN STOCK / 01-262

COA MSDS

EVEROLIMUS RELATED COMPOUND 3 | SECO RAPAMYCIN DEGRADATION PRODUCTS

Chemical Name: (2S)-1-[2-[(2R,3R,6S)-6-[(2S,3E,5E,7E,9S...

CAS No:
147438-30-0

Molecular Formula: C32H49NO9

Molecular Weight: 591.73

CAT No:
ALL-E02751

Keywords: SMILES string - CC1CCC(OC1(C(=O)C(=O)N2C...

Inventory Status:IN STOCK

COA MSDS

EVEROLIMUS RELATED COMPOUND 4

Chemical Name: EVEROLIMUS RELATED COMPOUND 4

CAS No:
N.A.

Molecular Formula: C57H91NO16

Molecular Weight: 1046.36

CAT No:
ALL-E04448

Keywords: EVEROLIMUS RELATED COMPOUND 4

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

EVEROLIMUS RELATED COMPOUND 6

Chemical Name: EVEROLIMUS RELATED COMPOUND 6

CAS No:
N.A.

Molecular Formula: C58H93NO15

Molecular Weight: 1044.39

CAT No:
ALL-E04439

Keywords: EVEROLIMUS RELATED COMPOUND 6

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

EVEROLIMUS RELATED COMPOUND 7

Chemical Name: EVEROLIMUS RELATED COMPOUND 7

CAS No:
N.A.

Molecular Formula: C53H81NO14

Molecular Weight: 956.22

CAT No:
ALL-E05622

Keywords: EVEROLIMUS RELATED COMPOUND 7

Inventory Status:DELIVERY IMMEDIATE

COA MSDS

EVEROLIMUS RETROALDOL DEGRADATION PRODUCT | EVEROLIMUS IMPURITY D (ISOMER 1 + ISOMER 2)

Chemical Name: (2R,3S,6R, 7E)-1-((1 S,3R,4R)-4-(2- Hydr...

CAS No:
1708118-13-1

Molecular Formula: C53H83NO14

Molecular Weight: 958.22

CAT No:
ALL-EVE-2690

Keywords: EVEROLIMUS RETROALDOL DEGRADATION PRODUC...

Inventory Status:IN STOCK / 01-104

COA MSDS

EVEROLIMUS TGR IMPURITY

Chemical Name: 42-O-tert-Butyldimethylsilyloxyethyl Rap...

CAS No:
159351-68-5

Molecular Formula: C59H97NO14Si

Molecular Weight: 1072.49

CAT No:
ALL-EVE-2654

Keywords: SMILES string - O=C(C([C@](O[C@]1([H])C[...

Inventory Status:IN STOCK/01-101

COA MSDS

EVEROLIMUS-O-ETHYL IMPURITY

Chemical Name: (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,2...

CAS No:
1704711-12-5

Molecular Formula: C54H85NO14

Molecular Weight: 972.28

CAT No:
ALL-E03115

Keywords: SMILES string - CC1CCC2CC(C(=CC=CC=CC(CC...

Inventory Status:IN STOCK / 01-199

COA MSDS

SECO-RAPAMYCIN

Chemical Name: 1-[2-[2-hydroxy-6-[14-hydroxy-22-(4-hydr...

CAS No:
148554-65-8/147438-27-5 (FREE BASE)

Molecular Formula: C51H78NNaO13 / C51H79NO13 (FREE BASE)

Molecular Weight: 936.15 / 914.17 (FREE BASE)

CAT No:
ALL-R03168

Keywords: SMILES string - O=C(N(CCCC1)[C@@H]1C(O)=...

Inventory Status:IN STOCK /01-255

COA MSDS

SIROLIMUS ISOMER A / SIROLIMUS TRIKETONE ISOMER

Chemical Name: (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S...

CAS No:
N.A

Molecular Formula: C51H79NO13

Molecular Weight: 914.17

CAT No:
ALL-R03885

Keywords: SMILES string - O=C(O[C@@H](CC([C@H](C)/...

Inventory Status:IN STOCK/01-1542

COA MSDS

SIROLIMUS ISOMER B | RAPAMYCIN ISOMER B

Chemical Name: SIROLIMUS

CAS No:
157182-37-1

Molecular Formula: C51H79NO13

Molecular Weight: 914.17

CAT No:
ALL-EVE-2669

Keywords: SMILES string - O=C(C([C@](O[C@]1([H])C[...

Inventory Status:IN STOCK /01-102

COA MSDS

SIROLIMUS ISOMER C | RAPAMYCIN ISOMER C

Chemical Name: (8S,11S,14R,15E,17R,18R,20R,22S,23E,25E,...

CAS No:
150821-39-9

Molecular Formula: C51H79NO13

Molecular Weight: 914.2

CAT No:
ALL-R03884

Keywords: SMILES string - CC1CCC2CC(C(=CC=CC=CC(CC...

Inventory Status:IN STOCK/01-264

COA MSDS

Key Everolimus Impurity Variants

Everolimus EP Impurity A (Sirolimus/Rapamycin) — CAS 53123-88-9; the parent macrolide and a common process-related impurity
Everolimus EP Impurity B (Seco Everolimus / 19 — Ene Open-Ring Impurity)-CAS 1062122-63-7; a ring-opened degradation product
Everolimus EP Impurity C (Desmethyl Everolimus) — used for identification testing per EP/USP monograph requirements
Everolimus EP Impurity E (42 — O-Formyl Rapamycin / Formyl Sirolimus)-CAS 1237826-25-3; an esterification-related impurity
Everolimus Impurity 1 (O — Desmethyl Everolimus)-CAS 745779-75-3; a demethylation-related substance monitored under USP related-compound testing

Allmpus Capability for the Everolimus Family

Allmpus Laboratories isolates and manufactures everolimus-related impurities using preparative chromatographic and force-degradation techniques appropriate to macrolide chemistry, which requires careful control of moisture, temperature, and light exposure given the compound class's sensitivity to hydrolysis and oxidation. Each impurity is delivered with a Certificate of Analysis (CoA) that includes ¹H NMR, ¹³C NMR, and mass spectral data to confirm structural identity and purity. Allmpus's synthetic and analytical chemistry teams work from EP and USP monograph specifications to produce impurities suited to system suitability testing, identification testing, and quantitative HPLC method validation, supporting manufacturers and CMOs working with everolimus tablets, oral suspensions, and drug-eluting stent coatings.

Frequently Asked Questions

What is the difference between Everolimus EP Impurity A and the everolimus drug substance itself?

Impurity A is sirolimus (rapamycin), the parent macrolide from which everolimus is chemically derived by hydroxyethylation. It is not a degradation product but a residual starting-material or process-related impurity that must be controlled per EP limits.

Are EP and USP designations for everolimus impurities always interchangeable?

Not always. Some impurities carry parallel designations (e.g., a compound may appear as an EP-lettered impurity and a USP-numbered related compound), but the two pharmacopeias do not always assign identical letters or numbers to the same substance, so cross-referencing CAS numbers and structures is recommended before specifying a standard.

What documentation accompanies Allmpus everolimus impurity standards?

Each standard ships with a Certificate of Analysis covering purity by HPLC, along with supporting NMR and mass spectrometry data confirming structural identity.