Is a Ph. Eur. monograph the same as a BP monograph?

For substances covered by the European Pharmacopoeia, the BP reproduces the Ph. Eur. text, so the requirements are identical. The BP also contains national monographs that have no Ph. Eur. equivalent.

What are specified impurities in a Ph. Eur. monograph?

They are named impurities with individual limits, listed in the transparency statement of the monograph. Laboratories need reference materials for them to identify and quantify each one.

Does the COA need to state the Ph. Eur. supplement?

It should state the edition, and ideally the supplement, that applies. Monographs can change between supplements, and auditors check that testing followed the version in force.

Chemical grade

Ph. Eur. Grade (European Pharmacopoeia) chemicals

Material that complies with its European Pharmacopoeia monograph, binding across the Ph. Eur. member states.

4,071 products in this grade

Ph. Eur. Grade (European Pharmacopoeia) products

1,465–1,488 of 4,071 products

Ethinylestradiol EP Impurity F

CAS: 56324-28-8
Formula: C₂₀H₂₄O₃
MW: 312.4 g/mol

ZX-024599

Ethinylestradiol EP Impurity G

CAS: 38002-18-5
Formula: C₂₀H₂₂O₃
MW: 310.4 g/mol

ZX-021606

Ethinylestradiol EP Impurity H

CAS: 1350468-76-6
Formula: C₂₀H₂₂O₃
MW: 310.4 g/mol

ZX-021610

Ethinylestradiol EP Impurity J

CAS: 15071-66-6
Formula: C₂₁H₂₆O₂
MW: 310.4 g/mol

ZX-021609

Ethinylestradiol EP Impurity K

CAS: 155683-61-7
Formula: C₂₁H₂₆O₂
MW: 310.4 g/mol

ZX-021604

Ethinylestradiol EP Impurity M

CAS: 3240-39-9
Formula: C₂₁H₂₆O₂
MW: 310.4 g/mol

ZX-021608

Ethionamide EP Impurity A

CAS: 2196-13-6
Formula: C₆H₆N₂S
MW: 138.19 g/mol

ZX-029376

Ethionamide EP Impurity F

CAS: 37581-44-5
Formula: C₁₀H₁₂N₂
MW: 160.22 g/mol

ZX-024612

Ethosuximide EP Impurity A

CAS: 631-31-2
Formula: C₇H₁₂O₄
MW: 160.17 g/mol

ZX-024618

Ethosuximide EP Impurity B

CAS: 50598-33-9
Formula: C₇H₁₀O₃
MW: 142.15 g/mol

ZX-024619

Ethyl acetate, EP/Ph. Eur.

CAS: 141-78-6
Formula: C₄H₈O₂
MW: 88.11 g/mol

ZX-038470

Ethyl cellulose, BP/USP/EP/Ph. Eur.

CAS: 9004-57-3
Formula: C₂₀H₃₈O₁₁
MW: 454.5 g/mol

ZX-038622

Ethyl methyl ketone, EP

CAS: 78-93-3
Formula: C₄H₈O
MW: 72.11 g/mol

ZX-038584

Ethyl methyl ketone, EP, AR

CAS: 78-93-3
Formula: C₄H₈O
MW: 72.11 g/mol

ZX-038583

Ethylal, EP

CAS: 462-95-3
Formula: C₅H₁₂O₂
MW: 104.15 g/mol

ZX-038615

Ethylenediaminetetraacetic acid, BP/EP 98.00–101.00%

CAS: 60-00-4
Formula: C₁₀H₁₆N₂O₈
MW: 292.24 g/mol

ZX-038230

Ethylenediaminetetraacetic acid, IP/BP/USP/EP/Ph. Eur., AR

CAS: 60-00-4
Formula: C₁₀H₁₆N₂O₈
MW: 292.24 g/mol

ZX-038625

Etilefrine EP impurity A

CAS: 22510-12-9
Formula: C₁₀H₁₃NO₂
MW: 179.22 g/mol

ZX-029389

Etodolac EP impurity A

CAS: 41339-67-7
Formula: C₁₅H₁₇NO₃
MW: 259.3 g/mol

ZX-021621

Etodolac EP Impurity B

CAS: 41340-19-6
Formula: C₁₆H₁₉NO₃
MW: 273.33 g/mol

ZX-021617

Etodolac EP Impurity C

CAS: 109518-47-0
Formula: C₁₆H₁₉NO₃
MW: 273.33 g/mol

ZX-024620

Etodolac EP Impurity C

CAS: 109518-50-5
Formula: C₁₆H₁₉NO₃
MW: 273.33 g/mol

ZX-024623

Etodolac EP impurity D

CAS: 57917-63-2
Formula: C₁₈H₂₃NO₃
MW: 301.4 g/mol

ZX-021622

Etodolac EP Impurity E

CAS: 57817-27-3
Formula: C₁₈H₂₃NO₃
MW: 301.4 g/mol

ZX-021618

Compare with other grades

HPLC Grade GC Grade AR Grade (Analytical Reagent)ACS Grade LR Grade (Laboratory Reagent)Extra Pure Grade Molecular Biology Grade Spectroscopy Grade LC-MS Grade IP Grade (Indian Pharmacopoeia)BP Grade (British Pharmacopoeia)USP Grade (United States Pharmacopeia)Food Grade (FCC)Technical Grade Electronic Grade Deuterated and Stable-Isotope-Labelled Compounds Pharmaceutical Secondary Reference Standards Grades guide

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