Erlotinib EP Impurity M

SZ CAT No:	SZ-E018069
CAS No	183322-21-6
Mol.F.	C12H11Cl3N2O2
Mol.Wt.	321.6
Inv. Status	Custom Synthesis

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SynZeal will update these details as per new development or finding in product specification without further noticed.

Chemical Name: 4-Chloro-6,7-bis(2-chloroethoxy)quinazoline (as per EP)

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: ClC1=NC=NC2=C1C=C(OCCCl)C(OCCCl)=C2

Erlotinib in combination with capecitabine and docetaxel in patients with metastatic breast cancer: A dose-escalation study
Chris Twelvesa, Jose´ M. Trigob , Rob Jonesc , Flavio De Rosad , Ashok Rakhite , Scott Fettnere , Tonya Wrightc , Jose´ Baselga
European journal of cancer 44 (2008) 419 – 426

Development and validation of a stability indicating HPLC method for the quantification of impurities in Erlotinib hydrochloride dosage forms
BabuC1, Narasimha RaoK.L1, DevannaN1, Suresh Reddy K.V.N

Solubility Measurement and Correlation of Two Erlotinib Hydrochloride Polymorphs in Alcohols and Ketones from 273.15 to 323.15 K
Jinghuan Zhai, Junrui Zhao, Zhenzhen Chen, Changwei Xiao, Xijian Liu, Lijuan Zhang, and Jie Lu
J. Chem. Eng. Data 2017, 62, 1, 516–524

Separation and Determination of Process-Related Impurities of Erlotinib Using Reverse-Phase HPLC with a Photo-Diode Array Detector
Chandrashekara KARUNAKARA, Udupi APARNA, Venkateshappa CHANDREGOWDA, and Chandrasekara G. REDDY
Analytical Sciences 28(3):305-8

Erlotinib EP Impurity M is chemically 4-Chloro-6,7-bis(2-chloroethoxy)quinazoline (as per EP). Erlotinib EP Impurity M is supplied with detailed characterization data compliant with regulatory guideline. Erlotinib EP Impurity M can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Erlotinib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.

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Erlotinib HCl

SZ CAT No:	: SZ-E018001
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Mol.F.	: C22H23N3O4 : HCl
Mol.Wt.	: 393.4 : 36.5
Inv. Status	: In Stock
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Erlotinib EP Impurity A

SZ CAT No:	: SZ-E018006
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Mol.F.	: C14H18N2O5
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Erlotinib 4-Hydroxy Metabolite

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CAS No	: NA
Mol.F.	: C22H23N3O5 : HCl
Mol.Wt.	: 409.4 : 36.4
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Didesmethyl Erlotinib

SZ CAT No:	: SZ-E018008
CAS No	: 183321-84-8
Mol.F.	: C20H19N3O4
Mol.Wt.	: 365.4
Inv. Status	: In Stock

Erlotinib EP Impurity D

SZ CAT No:	: SZ-E018009
CAS No	: 183322-18-1
Mol.F.	: C14H17ClN2O4
Mol.Wt.	: 312.8
Inv. Status	: In Stock

Erlotinib EP Impurity H

SZ CAT No:	: SZ-E018010
CAS No	: 183320-19-6
Mol.F.	: C21H20ClN3O3 : HCl
Mol.Wt.	: 397.9 : 36.5
Inv. Status	: In Stock
Rel. CAS No	: 183321-85-9 (free base)

Erlotinib EP Impurity B

SZ CAT No:	: SZ-E018011
CAS No	: 54060-30-9
Mol.F.	: C8H7N
Mol.Wt.	: 117.2
Inv. Status	: In Stock

Erlotinib metabolite M11

SZ CAT No:	: SZ-E018012
CAS No	: 1170354-84-3
Mol.F.	: C21H19N3O5
Mol.Wt.	: 393.4
Inv. Status	: Custom Synthesis

N-Methoxyethyl Erlotinib HCl

SZ CAT No:	: SZ-E018013
CAS No	: NA
Mol.F.	: C25H29N3O5 : HCl
Mol.Wt.	: 451.5 : 36.5
Inv. Status	: In Stock
Rel. CAS No	: 2410548-58-0 (free base)

Erlotinib Carboxylic Acid

SZ CAT No:	: SZ-E018015
CAS No	: 882420-21-5
Mol.F.	: C22H25N3O6
Mol.Wt.	: 427.5
Inv. Status	: In Stock

Erlotinib EP Impurity E

SZ CAT No:	: SZ-E018016
CAS No	: 1058132-82-3
Mol.F.	: C22H25N3O4
Mol.Wt.	: 395.5
Inv. Status	: In Stock

Erlotinib Impurity 1

SZ CAT No:	: SZ-E018017
CAS No	: 1710372-46-5
Mol.F.	: C14H16Cl2N2O4
Mol.Wt.	: 347.2
Inv. Status	: Custom Synthesis

Erlotinib EP Impurity G

SZ CAT No:	: SZ-E018018
CAS No	: 183322-19-2
Mol.F.	: C13H14Cl2N2O3
Mol.Wt.	: 317.2
Inv. Status	: Custom Synthesis

Erlotinib EP Impurity K

SZ CAT No:	: SZ-E018019
CAS No	: 2204518-92-1
Mol.F.	: C22H24ClN3O4
Mol.Wt.	: 429.9
Inv. Status	: Out of Stock

Erlotinib EP Impurity J

SZ CAT No:	: SZ-E018020
CAS No	: 183321-83-7
Mol.F.	: C21H20ClN3O3
Mol.Wt.	: 397.9
Inv. Status	: In Stock

Erlotinib EP Impurity L

SZ CAT No:	: SZ-E018022
CAS No	: 183321-82-6
Mol.F.	: C20H17Cl2N3O2
Mol.Wt.	: 402.3
Inv. Status	: In Stock

Erlotinib Impurity 7

SZ CAT No:	: SZ-E018023
CAS No	: 950596-58-4
Mol.F.	: C13H18N2O4
Mol.Wt.	: 266.3
Inv. Status	: Custom Synthesis

Erlotinib Acetate

SZ CAT No:	: SZ-E018024
CAS No	: 2055840-54-3
Mol.F.	: C24H25N3O5
Mol.Wt.	: 435.5
Inv. Status	: In Stock

Erlotinib Impurity 9

SZ CAT No:	: SZ-E018025
CAS No	: 328528-74-1
Mol.F.	: C20H22BrN3O4
Mol.Wt.	: 448.3
Inv. Status	: In Stock

Erlotinib Impurity 10

SZ CAT No:	: SZ-E018026
CAS No	: 183322-17-0
Mol.F.	: C15H23NO6 : HCl
Mol.Wt.	: 313.4 : 36.5
Inv. Status	: Custom Synthesis
Rel. CAS No	: 179688-27-8 (free base)

Erlotinib Impurity 11

SZ CAT No:	: SZ-E018027
CAS No	: 179688-26-7
Mol.F.	: C15H21NO8
Mol.Wt.	: 343.3
Inv. Status	: In Stock

Erlotinib Impurity 12

SZ CAT No:	: SZ-E018028
CAS No	: 1145671-52-8
Mol.F.	: C20H23N3O4
Mol.Wt.	: 369.4
Inv. Status	: In Stock

Erlotinib EP Impurity I

SZ CAT No:	: SZ-E018029
CAS No	: 183322-20-5
Mol.F.	: C13H14Cl2N2O3
Mol.Wt.	: 317.2
Inv. Status	: Custom Synthesis

Erlotinib Impurity 14

SZ CAT No:	: SZ-E018031
CAS No	: 950596-59-5
Mol.F.	: C16H23N3O4
Mol.Wt.	: 321.4
Inv. Status	: In Stock

Erlotinib Impurity 16

SZ CAT No:	: SZ-E018033
CAS No	: 1241475-15-9
Mol.F.	: C16H25N3O5
Mol.Wt.	: 339.4
Inv. Status	: Custom Synthesis

Erlotinib Impurity 17

SZ CAT No:	: SZ-E018034
CAS No	: 236750-65-5
Mol.F.	: C13H16N2O6
Mol.Wt.	: 296.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 18

SZ CAT No:	: SZ-E018035
CAS No	: 236750-62-2
Mol.F.	: C13H20N2O5
Mol.Wt.	: 284.3
Inv. Status	: Out of Stock

Erlotinib Impurity 19

SZ CAT No:	: SZ-E018036
CAS No	: 2512209-22-0
Mol.F.	: C15H23NO6
Mol.Wt.	: 313.4
Inv. Status	: Custom Synthesis

Erlotinib Impurity 20

SZ CAT No:	: SZ-E018037
CAS No	: NA
Mol.F.	: C22H23N3O6
Mol.Wt.	: 393.5
Inv. Status	: Custom Synthesis

Erlotinib Impurity 21

SZ CAT No:	: SZ-E018038
CAS No	: 2055841-66-0
Mol.F.	: C22H27N3O4 : HCl
Mol.Wt.	: 397.5 : 36.5
Inv. Status	: In Stock
Rel. CAS No	: 299912-61-1 (free base)

Erlotinib Methoxy Impurity

SZ CAT No:	: SZ-E018039
CAS No	: 1312937-41-9
Mol.F.	: C15H20N2O5
Mol.Wt.	: 308.3
Inv. Status	: In Stock

Erlotinib Impurity 23

SZ CAT No:	: SZ-E018040
CAS No	: 1417161-98-8
Mol.F.	: C14H19N3O4
Mol.Wt.	: 293.3
Inv. Status	: In Stock

Erlotinib Impurity 24

SZ CAT No:	: SZ-E018041
CAS No	: 938185-06-9
Mol.F.	: C16H11N3O2
Mol.Wt.	: 277.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 15

SZ CAT No:	: SZ-E018032
CAS No	: 3943-89-3
Mol.F.	: C9H10O4
Mol.Wt.	: 182.2
Inv. Status	: In Stock

Erlotinib Impurity 25

SZ CAT No:	: SZ-E018042
CAS No	: 585-79-5
Mol.F.	: C6H4BrNO2
Mol.Wt.	: 202
Inv. Status	: In Stock

Erlotinib Impurity 26

SZ CAT No:	: SZ-E018043
CAS No	: 115-19-5
Mol.F.	: C5H8O
Mol.Wt.	: 84.1
Inv. Status	: In Stock

Erlotinib Impurity 27

SZ CAT No:	: SZ-E018044
CAS No	: 183322-16-9
Mol.F.	: C15H22O6
Mol.Wt.	: 298.3
Inv. Status	: In Stock

Erlotinib Aldehyde

SZ CAT No:	: SZ-E018045
CAS No	: 1278586-80-3
Mol.F.	: C21H23N3O5
Mol.Wt.	: 397.4
Inv. Status	: Custom Synthesis

Erlotinib Impurity 29

SZ CAT No:	: SZ-E018046
CAS No	: 882172-54-5
Mol.F.	: C22H27N3O6
Mol.Wt.	: 429.5
Inv. Status	: In Stock

Erlotinib Impurity 30

SZ CAT No:	: SZ-E018047
CAS No	: NA
Mol.F.	: C22H25N3O5
Mol.Wt.	: 411.5
Inv. Status	: Custom Synthesis

Erlotinib D4

SZ CAT No:	: SZ-E018D01
CAS No	: 1130852-41-3
Mol.F.	: C22H19D4N3O4
Mol.Wt.	: 397.5
Inv. Status	: Custom Synthesis

Erlotinib D6

SZ CAT No:	: SZ-E018D02
CAS No	: 1034651-23-4
Mol.F.	: C22H17D6N3O4
Mol.Wt.	: 399.5
Inv. Status	: Custom Synthesis

Erlotinib Impurity 31

SZ CAT No:	: SZ-E018048
CAS No	: 183320-24-3
Mol.F.	: C23H23N3O5
Mol.Wt.	: 421.5
Inv. Status	: Custom Synthesis

Desmethyl Erlotinib Acetate

SZ CAT No:	: SZ-E018049
CAS No	: 183320-15-2
Mol.F.	: C23H23N3O5
Mol.Wt.	: 421.5
Inv. Status	: Custom Synthesis

O-Erlotinib Nitro Compound

SZ CAT No:	: SZ-E018050
CAS No	: 2732925-07-2
Mol.F.	: C15H21NO8
Mol.Wt.	: 343.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 32

SZ CAT No:	: SZ-E018051
CAS No	: 2518426-67-8
Mol.F.	: C15H23NO6 : HCl
Mol.Wt.	: 313.4 : 36.5
Inv. Status	: Custom Synthesis
Rel. CAS No	: 2518426-66-7 (free base)

Erlotinib Related compound A

SZ CAT No:	: SZ-E018052
CAS No	: NA
Mol.F.	: C24H31N3O5 : HCl
Mol.Wt.	: 441.5 : 36.5
Inv. Status	: Custom Synthesis

Erlotinib Impurity 5

SZ CAT No:	: SZ-E018021
CAS No	: 2596073-36-6
Mol.F.	: C22H23N3O5
Mol.Wt.	: 409.4
Inv. Status	: Custom Synthesis

Desalkyne Erlotinib Benzoic Acid

SZ CAT No:	: SZ-E018053
CAS No	: 1809351-86-7
Mol.F.	: C21H23N3O6
Mol.Wt.	: 413.4
Inv. Status	: In Stock

Erlotinib Lactose Adduct

SZ CAT No:	: SZ-E018054
CAS No	: NA
Mol.F.	: C34H43N3O14
Mol.Wt.	: 717.7
Inv. Status	: Custom Synthesis

Erlotinib Impurity 33

SZ CAT No:	: SZ-E018055
CAS No	: 1839513-98-2
Mol.F.	: C13H17N3O4
Mol.Wt.	: 279.3
Inv. Status	: Custom Synthesis

M-Erlotinib Nitro Compound

SZ CAT No:	: SZ-E018056
CAS No	: 2713768-85-3
Mol.F.	: C15H21NO8
Mol.Wt.	: 343.3
Inv. Status	: Custom Synthesis

Desmethyl Erlotinib Hydrochloride

SZ CAT No:	: SZ-E018014
CAS No	: 183320-51-6
Mol.F.	: C21H21N3O4 : HCl
Mol.Wt.	: 379.4 : 36.5
Inv. Status	: Custom Synthesis
Rel. CAS No	: 183321-86-0 (free base)

7-O-Desmethyl Erlotinib Hydrochloride

SZ CAT No:	: SZ-E018057
CAS No	: 183365-34-6
Mol.F.	: C21H21N3O4 : HCl
Mol.Wt.	: 379.4 : 36.5
Inv. Status	: Custom Synthesis
Rel. CAS No	: 183320-29-8 (free base)

Erlotinib EP Impurity C HCl salt

SZ CAT No:	: SZ-E018058
CAS No	: NA
Mol.F.	: C22H25N3O5 : HCl
Mol.Wt.	: 411.5 : 36.5
Inv. Status	: In Stock
Rel. CAS No	: 1354727-63-1 (free base)

3-Ethynylaniline-d4

SZ CAT No:	: SZ-E018D03
CAS No	: 1794883-73-0
Mol.F.	: C8H3D4N
Mol.Wt.	: 121.2
Inv. Status	: Custom Synthesis

Erlotinib Nitroso Impurity

SZ CAT No:	: SZ-E018059
CAS No	: NA
Mol.F.	: C22H22N4O5
Mol.Wt.	: 422.4
Inv. Status	: Custom Synthesis

Erlotinib Impurity 36

SZ CAT No:	: SZ-E018060
CAS No	: NA
Mol.F.	: C14H19ClN2O4
Mol.Wt.	: 314.8
Inv. Status	: Custom Synthesis

Erlotinib Impurity 37

SZ CAT No:	: SZ-E018061
CAS No	: NA
Mol.F.	: C16H22N2O5
Mol.Wt.	: 322.4
Inv. Status	: Custom Synthesis

Erlotinib Impurity 38

SZ CAT No:	: SZ-E018062
CAS No	: NA
Mol.F.	: C12H16O5
Mol.Wt.	: 240.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 39

SZ CAT No:	: SZ-E018063
CAS No	: 1012057-39-4
Mol.F.	: C12H16O5
Mol.Wt.	: 240.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 40

SZ CAT No:	: SZ-E018064
CAS No	: 1061230-98-5
Mol.F.	: C14H20O6
Mol.Wt.	: 284.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 41

SZ CAT No:	: SZ-E018065
CAS No	: 1061231-00-2
Mol.F.	: C14H20O6
Mol.Wt.	: 284.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 42

SZ CAT No:	: SZ-E018066
CAS No	: NA
Mol.F.	: C13H17NO8
Mol.Wt.	: 315.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 43

SZ CAT No:	: SZ-E018067
CAS No	: NA
Mol.F.	: C13H15Cl2NO6
Mol.Wt.	: 352.2
Inv. Status	: Custom Synthesis

Erlotinib EP Impurity F

SZ CAT No:	: SZ-E018068
CAS No	: 1809951-10-7
Mol.F.	: C28H34N4O9
Mol.Wt.	: 570.6
Inv. Status	: Custom Synthesis

Erlotinib EP Impurity M

SZ CAT No:	: SZ-E018069
CAS No	: 183322-21-6
Mol.F.	: C12H11Cl3N2O2
Mol.Wt.	: 321.6
Inv. Status	: Custom Synthesis

Erlotinib Impurity 44

SZ CAT No:	: SZ-E018070
CAS No	: 2805078-67-3
Mol.F.	: C16H25NO6
Mol.Wt.	: 327.4
Inv. Status	: Custom Synthesis

Erlotinib Impurity 45

SZ CAT No:	: SZ-E018071
CAS No	: 591-19-5
Mol.F.	: C6H6BrN
Mol.Wt.	: 172.0
Inv. Status	: Custom Synthesis
Rel. CAS No	: 56967-17-0 (HCl salt)

Erlotinib USP Related Compound A

SZ CAT No:	: SZ-E018072
CAS No	: NA
Mol.F.	: C25H29N3O5 : HCl : H2O
Mol.Wt.	: 451.5 : 36.5 : 18.0
Inv. Status	: In Stock
Rel. CAS No	: 299912-60-0 (free base) ; 299912-59-7 (HCl salt)

Erlotinib Impurity 46

SZ CAT No:	: SZ-E018073
CAS No	: 2744061-39-8
Mol.F.	: C12H15NO7
Mol.Wt.	: 285.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 47

SZ CAT No:	: SZ-E018074
CAS No	: 2751727-04-3
Mol.F.	: C12H15NO7
Mol.Wt.	: 285.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 48

SZ CAT No:	: SZ-E018075
CAS No	: NA
Mol.F.	: C14H19NO8
Mol.Wt.	: 329.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 49

SZ CAT No:	: SZ-E018076
CAS No	: NA
Mol.F.	: C14H19NO8
Mol.Wt.	: 329.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 50

SZ CAT No:	: SZ-E018077
CAS No	: 574738-66-2
Mol.F.	: C13H19NO6
Mol.Wt.	: 285.3
Inv. Status	: Custom Synthesis

Erlotinib Impurity 51

SZ CAT No:	: SZ-E018078
CAS No	: NA
Mol.F.	: C25H33N3O5
Mol.Wt.	: 455.6
Inv. Status	: Custom Synthesis

Erlotinib 13C6 Hydrochloride

SZ CAT No:	: SZ-E018D04
CAS No	: 1210610-07-3
Mol.F.	: C1613C6H23N3O4 : HCl
Mol.Wt.	: 399.4 : 36.5
Inv. Status	: Custom Synthesis
Rel. CAS No	: 1211107-68-4 (free base)

Desmethyl Erlotinib-d4

SZ CAT No:	: SZ-E018D05
CAS No	: 1216420-11-9
Mol.F.	: C21H17D4N3O4
Mol.Wt.	: 383.4
Inv. Status	: Custom Synthesis

Erlotinib

SZ CAT No:	: SZ-E018079
CAS No	: 183321-74-6
Mol.F.	: C22H23N3O4
Mol.Wt.	: 393.4
Inv. Status	: Custom Synthesis
Rel. CAS No	: 1094445-14-3 (hydrate salt) ; 183319-69-9 (HCl salt) ; 1310461-08-5 (HBr salt)

Erlotinib EP Impurity M

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