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

1,705–1,728 of 4,071 products

Formaldehyde solution, BP/USP/EP

CAS: 50-00-0
Formula: CH₂O
MW: 30.03 g/mol

ZX-037958

Formaldehyde solution, BP/USP/EP/Ph. Eur., AR 41%

CAS: 50-00-0
Formula: CH₂O
MW: 30.03 g/mol

ZX-038630

Formoterol EP Impurity A

CAS: 150513-24-9
Formula: C₁₈H₂₄N₂O₃
MW: 316.4 g/mol

ZX-021749

Formoterol EP Impurity B

CAS: 1224588-66-2
Formula: C₁₈H₂₂N₂O₄
MW: 330.4 g/mol

ZX-024859

Formoterol EP Impurity C

CAS: 1795135-61-3
Formula: C₂₀H₂₆N₂O₄
MW: 358.4 g/mol

ZX-021744

Formoterol EP Impurity D

CAS: 1795133-96-8
Formula: C₂₀H₂₆N₂O₄
MW: 358.4 g/mol

ZX-021745

Formoterol EP Impurity E

CAS: 1616967-26-0
Formula: C₂₀H₂₆N₂O₄
MW: 358.4 g/mol

ZX-021743

Formoterol EP Impurity F

CAS: 1795129-59-7
Formula: C₃₇H₄₆N₄O₆
MW: 642.8 g/mol

ZX-024858

Formoterol EP Impurity G HCl

CAS: 3706-26-1
Formula: C₁₀H₁₆ClNO
MW: 201.69 g/mol

ZX-033507

Formoterol EP Impurity H

CAS: 2514947-17-0
Formula: C₂₆H₃₀N₂O₄
MW: 434.5 g/mol

ZX-021746

Formoterol EP Impurity I

CAS: 532414-36-1
Formula: C₁₉H₂₄N₂O₄
MW: 344.4 g/mol

ZX-021747

Formoterol Fumarate Dihydrate EP Impurity I (R,S-isomer) ((R,S)-Formoterol)

CAS: 67346-51-4
Formula: C₁₉H₂₄N₂O₄
MW: 344.4 g/mol

ZX-028066

Formoterol Fumarate Dihydrate EP Impurity I (S,R-isomer) ((S,R)-Formoterol)

CAS: 67346-50-3
Formula: C₁₉H₂₄N₂O₄
MW: 344.4 g/mol

ZX-028065

Foscarnet Sodium EP Impurity A

CAS: 72305-00-1
Formula: C₃H₅Na₂O₅P
MW: 198.02 g/mol

ZX-029634

Foscarnet sodium EP Impurity B

CAS: 55920-24-6
Formula: C₃H₅Na₂O₅P
MW: 198.02 g/mol

ZX-024864

Foscarnet Sodium EP Impurity C

CAS: 72304-94-0
Formula: C₅H₁₀NaO₅P
MW: 204.09 g/mol

ZX-024865

Foscarnet Sodium EP Impurity D

CAS: 1474-78-8
Formula: C₇H₁₅O₅P
MW: 210.16 g/mol

ZX-024863

Fosfomycin Trometamol EP Impurity A

CAS: 84954-80-3
Formula: C₃H₉O₅P
MW: 156.07 g/mol

ZX-024868

Fosfomycin Trometamol EP Impurity B

CAS: 1262243-11-7
Formula: C₇H₁₈NO₇P
MW: 259.19 g/mol

ZX-024870

Fosfomycin Trometamol EP Impurity C

CAS: 23001-39-0
Formula: C₄H₁₂NO₆P
MW: 201.12 g/mol

ZX-024869

Fosfomycin Trometamol EP Impurity D

CAS: 1262243-12-8
Formula: C₁₀H₂₅NO₁₁P₂
MW: 397.25 g/mol

ZX-024867

Fosinopril EP Impurity A

CAS: 95399-71-6
Formula: C₂₃H₃₄NO₅P
MW: 435.5 g/mol

ZX-024874

Fosinopril EP Impurity B

CAS: 1910773-95-3
Formula: C₃₀H₄₆NO₇P
MW: 563.7 g/mol

ZX-033516

Fosinopril EP Impurity C

CAS: 474519-28-3
Formula: C₃₀H₄₆NO₇P
MW: 563.7 g/mol

ZX-029636

Compare with other grades

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