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

4,057–4,071 of 4,071 products

Ziprasidone EP Impurity B (Freebase)

CAS: 1159977-56-6
Formula: C₂₁H₁₉ClN₄O₂S
MW: 426.9 g/mol

ZX-006072

Ziprasidone EP Impurity C

CAS: 1159977-64-6
Formula: C₂₁H₂₃ClN₄O₂S
MW: 431 g/mol

ZX-006073

Ziprasidone EP Impurity E

CAS: 1159977-04-4
Formula: C₂₈H₂₄ClN₅OS₂
MW: 546.1 g/mol

ZX-006074

Zoledronic Acid EP Impurity A

CAS: 1627731-60-5
Formula: C₇H₁₂N₂O₉P₂
MW: 330.13 g/mol

ZX-023064

Zoledronic Acid EP Impurity B

CAS: 1632236-60-2
Formula: C₇H₁₆N₂O₁₄P₄
MW: 476.1 g/mol

ZX-027669

Zoledronic Acid EP Impurity D

CAS: 22884-10-2
Formula: C₅H₆N₂O₂
MW: 126.11 g/mol

ZX-006075

Zolmitriptan EP Impurity A

CAS: 139264-24-7
Formula: C₁₆H₂₁N₃O₂
MW: 287.36 g/mol

ZX-023069

Zolmitriptan EP Impurity D

CAS: 139264-15-6
Formula: C₁₄H₁₇N₃O₂
MW: 259.3 g/mol

ZX-027672

Zolmitriptan EP Impurity E

CAS: 152305-23-2
Formula: C₁₀H₁₂N₂O₂
MW: 192.21 g/mol

ZX-023067

Zolmitriptan EP Impurity I

CAS: 659738-69-9
Formula: C₁₇H₂₁N₃O₄
MW: 331.4 g/mol

ZX-023070

Zopiclone EP Impurity A

CAS: 43200-96-0
Formula: C₁₇H₁₇ClN₆O₄
MW: 404.8 g/mol

ZX-006076

Zopiclone EP Impurity B

CAS: 43200-81-3
Formula: C₁₁H₇ClN₄O₂
MW: 262.65 g/mol

ZX-006077

Zopiclone EP impurity C

CAS: 148891-53-6
Formula: C₁₁H₇ClN₄O
MW: 246.65 g/mol

ZX-006078

Zuclopenthixol Decanoate EP Impurity C

CAS: 53772-83-1
Formula: C₂₂H₂₅ClN₂OS
MW: 401 g/mol

ZX-032799

α-Naphtholbenzein (pH Indicator), BP/USP/EP/Ph. Eur.

CAS: 145-50-6
Formula: C₂₇H₁₈O₂
MW: 374.4 g/mol

ZX-038683

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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