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

73–96 of 4,071 products

Aciclovir EP Impurity C

CAS: 91702-61-3
Formula: C₈H₁₁N₅O₃
MW: 225.2 g/mol

ZX-019788

Aciclovir EP Impurity F

CAS: 110104-37-5
Formula: C₁₀H₁₃N₅O₄
MW: 267.24 g/mol

ZX-019789

Aciclovir EP Impurity G

CAS: 75128-73-3
Formula: C₁₂H₁₅N₅O₅
MW: 309.28 g/mol

ZX-019790

Aciclovir EP Impurity I

CAS: 1797832-75-7
Formula: C₁₄H₁₆N₁₀O₄
MW: 388.34 g/mol

ZX-019792

Aciclovir EP Impurity J

CAS: 166762-90-9
Formula: C₁₄H₁₆N₁₀O₄
MW: 388.34 g/mol

ZX-019793

Aciclovir EP Impurity L

CAS: 3056-33-5
Formula: C₉H₉N₅O₃
MW: 235.2 g/mol

ZX-019794

Aciclovir EP Impurity M

CAS: 91702-60-2
Formula: C₁₂H₁₅N₅O₅
MW: 309.28 g/mol

ZX-019797

Aciclovir EP Impurity P

CAS: 23169-33-7
Formula: C₇H₉N₅O₂
MW: 195.18 g/mol

ZX-019796

Acitretin EP Impurity A

CAS: 69427-46-9
Formula: C₂₁H₂₆O₃
MW: 326.4 g/mol

ZX-019722

Acitretin EP Impurity B

CAS: 54350-48-0
Formula: C₂₃H₃₀O₃
MW: 354.5 g/mol

ZX-019784

Acyclovir EP Impurity H

CAS: 133186-23-9
Formula: C₁₇H₁₇N₅O₅
MW: 371.3 g/mol

ZX-019791

Adapalene EP Impurity A

CAS: 932033-58-4
Formula: C₂₂H₁₄O₄
MW: 342.3 g/mol

ZX-020481

Adapalene EP Impurity B

CAS: 1346599-76-5
Formula: C₂₈H₂₈O₄
MW: 428.5 g/mol

ZX-020486

Adapalene EP Impurity C

CAS: 43109-77-9
Formula: C₁₇H₂₂O
MW: 242.36 g/mol

ZX-020482

Adapalene EP Impurity D

CAS: 932033-57-3
Formula: C₃₄H₄₂O₂
MW: 482.7 g/mol

ZX-020483

Adipic acid, EP

CAS: 124-04-9
Formula: C₆H₁₀O₄
MW: 146.14 g/mol

ZX-038551

Adrenaline bitartrate, IP/BP/USP/EP/Ph. Eur.

CAS: 51-42-3
Formula: C₁₃H₁₉NO₉
MW: 333.29 g/mol

ZX-038552

Adrenaline EP Impurity D

CAS: 317351-40-9
Formula: C₁₆H₁₉NO₃
MW: 273.33 g/mol

ZX-020494

Adrenaline EP Impurity E

CAS: 36467-25-1
Formula: C₁₆H₁₇NO₃
MW: 271.31 g/mol

ZX-020489

Adrenaline EP Impurity E Hydrochloride

CAS: 317351-39-6
Formula: C₁₆H₁₈ClNO₃
MW: 307.77 g/mol

ZX-027909

Adrenaline EP Impurity F

CAS: 78995-75-2
Formula: C₉H₁₃NO₅S
MW: 247.27 g/mol

ZX-020491

Albendazole EP Impurity A

CAS: 80983-36-4
Formula: C₁₀H₁₃N₃S
MW: 207.3 g/mol

ZX-020516

Albendazole EP Impurity B

CAS: 54029-12-8
Formula: C₁₂H₁₅N₃O₃S
MW: 281.33 g/mol

ZX-020517

Albendazole EP Impurity C

CAS: 75184-71-3
Formula: C₁₂H₁₅N₃O₄S
MW: 297.33 g/mol

ZX-020518

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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