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

337–360 of 4,071 products

Atorvastatin EP Impurity K

CAS: 345891-62-5
Formula: C₃₄H₃₇FN₂O₅
MW: 572.7 g/mol

ZX-005595

Atorvastatin EP Impurity M

CAS: 1146977-93-6
Formula: C₃₅H₃₉FN₂O₅
MW: 586.7 g/mol

ZX-005596

Atorvastatin EP Impurity P

CAS: 581772-29-4
Formula: C₃₆H₃₉FN₂O₅
MW: 598.7 g/mol

ZX-005597

Atorvastatin EP Impurity Q

CAS: 906552-18-9
Formula: C₃₃H₃₅FN₂O₆
MW: 574.6 g/mol

ZX-020715

Atovaquone EP Impurity B

CAS: 137732-39-9
Formula: C₂₂H₁₉ClO₃
MW: 366.8 g/mol

ZX-027692

Atovaquone EP Impurity C

CAS: 1809464-27-4
Formula: C₂₂H₁₇ClO₃
MW: 364.8 g/mol

ZX-020721

Atovaquone EP Impurity D

CAS: 129700-41-0
Formula: C₂₃H₂₁ClO₃
MW: 380.9 g/mol

ZX-020722

Atracurium Besylate EP Impurity B

CAS: 64228-84-8
Formula: C₅₁H₆₆N₂O₁₂
MW: 899.1 g/mol

ZX-020726

Atracurium EP Impurity B

CAS: 64228-77-9
Formula: C₅₁H₆₆N₂O₁₂
MW: 899.1 g/mol

ZX-028125

Atracurium EP Impurity D Iodide (Mixture of Diastereomers)

CAS: 2767988-76-9
Formula: C₂₉H₄₂INO₇
MW: 643.5 g/mol

ZX-028124

Atracurium EP Impurity J

CAS: 80-18-2
Formula: C₇H₈O₃S
MW: 172.2 g/mol

ZX-005598

Atropine EP Impurity B

CAS: 16839-98-8
Formula: C₁₆H₂₁NO₃
MW: 275.34 g/mol

ZX-023428

Atropine EP impurity B hydrochloride

CAS: 75559-01-2
Formula: C₁₆H₂₂ClNO₃
MW: 311.8 g/mol

ZX-033067

Atropine EP Impurity E

CAS: 949092-65-3
Formula: C₁₇H₂₃NO₄
MW: 305.4 g/mol

ZX-023430

Atropine sulphate, IP/BP/USP/EP/Ph. Eur.

CAS: 5908-99-6
Formula: C₃₄H₅₀N₂O₁₁S
MW: 694.8 g/mol

ZX-038571

Atropine sulphate, IP/BP/USP/EP/Ph. Eur., LR 99.0–101%

CAS: 5908-99-6
Formula: C₃₄H₅₀N₂O₁₁S
MW: 694.8 g/mol

ZX-037687

Azathioprine EP Impurity A

CAS: 4531-54-8
Formula: C₄H₆N₄O₂
MW: 142.12 g/mol

ZX-019921

Azathioprine EP Impurity B

CAS: 157930-13-7
Formula: C₅H₄N₄S
MW: 152.18 g/mol

ZX-032805

Azathioprine EP Impurity D

CAS: 6339-54-4
Formula: C₄H₅N₃O₂S
MW: 159.17 g/mol

ZX-019923

Azathioprine EP Impurity E

CAS: 73703-74-9
Formula: C₄H₅N₃O₃
MW: 143.1 g/mol

ZX-023078

Azathioprine EP Impurity E Sodium Salt

CAS: 35681-68-6
Formula: C₄H₄N₃NaO₃
MW: 165.08 g/mol

ZX-023462

Azathioprine EP Impurity G

CAS: 5581-52-2
Formula: C₉H₈N₈O₂S
MW: 292.28 g/mol

ZX-019922

Azelastine EP Impurity B

CAS: 117078-69-0
Formula: C₁₄H₂₂ClN₃O
MW: 283.8 g/mol

ZX-020749

Azelastine EP Impurity B

CAS: 110406-94-5
Formula: C₁₄H₂₁N₃O
MW: 247.34 g/mol

ZX-028175

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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