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

2,257–2,280 of 4,071 products

Lidocaine EP Impurity C

CAS: 2198-53-0
Formula: C₁₀H₁₃NO
MW: 163.22 g/mol

ZX-022016

Lidocaine EP Impurity D

CAS: 7728-40-7
Formula: C₁₂H₁₈N₂O
MW: 206.28 g/mol

ZX-030273

Lidocaine EP Impurity D Hydrochloride

CAS: 7729-94-4
Formula: C₁₂H₁₉ClN₂O
MW: 242.74 g/mol

ZX-022017

Lidocaine EP Impurity E

CAS: 745798-07-6
Formula: C₂₀H₂₅N₃O₂
MW: 339.4 g/mol

ZX-022018

Lidocaine EP Impurity E Hydrochloride

CAS: 1135231-62-7
Formula: C₂₀H₂₆ClN₃O₂
MW: 375.9 g/mol

ZX-030270

Lidocaine EP Impurity F

CAS: 142713-08-4
Formula: C₁₄H₂₂N₂O
MW: 234.34 g/mol

ZX-030274

Lidocaine EP Impurity F Hydrochloride

CAS: 857170-72-0
Formula: C₁₄H₂₃ClN₂O
MW: 270.8 g/mol

ZX-025394

Lidocaine EP Impurity G

CAS: 42459-30-3
Formula: C₁₃H₂₀N₂O
MW: 220.31 g/mol

ZX-025400

Lidocaine EP Impurity G

CAS: 35891-87-3
Formula: C₁₃H₂₁ClN₂O
MW: 256.77 g/mol

ZX-030269

Lidocaine EP Impurity H

CAS: 1131-01-7
Formula: C₁₀H₁₂ClNO
MW: 197.66 g/mol

ZX-005800

Lidocaine EP Impurity I

CAS: 17289-53-1
Formula: C₁₄H₂₂N₂O
MW: 234.34 g/mol

ZX-025395

Lidocaine EP Impurity I

CAS: 17289-54-2
Formula: C₁₄H₂₃ClN₂O
MW: 270.8 g/mol

ZX-025399

Lidocaine EP Impurity J

CAS: 857570-37-7
Formula: C₁₄H₂₂N₂O
MW: 234.34 g/mol

ZX-025396

Lidocaine EP Impurity J

CAS: 1012864-23-1
Formula: C₁₄H₂₃ClN₂O
MW: 270.8 g/mol

ZX-030272

Lidocaine EP Impurity K

CAS: 74634-66-5
Formula: C₁₃H₂₀N₂O
MW: 220.31 g/mol

ZX-022019

Lidocaine EP Impurity K Hydrochloride

CAS: 50295-20-0
Formula: C₁₃H₂₁ClN₂O
MW: 256.77 g/mol

ZX-033727

Lincomycin EP Impurity B (Mixture of Diastereomers)

CAS: 37744-65-3
Formula: C₁₈H₃₂N₂O₆S
MW: 404.5 g/mol

ZX-030298

Lincomycin EP Impurity C

CAS: 2256-16-8
Formula: C₁₇H₃₂N₂O₆S
MW: 392.5 g/mol

ZX-030305

Lincomycin EP Impurity C (N-Desmethyl HCl)

CAS: 14600-41-0
Formula: C₁₇H₃₃ClN₂O₆S
MW: 429 g/mol

ZX-030300

Lincomycin EP Impurity D

CAS: 17017-22-0
Formula: C₁₈H₃₄N₂O₆S
MW: 406.5 g/mol

ZX-028660

Lincomycin EP Impurity D Hydrochloride

CAS: 26389-84-4
Formula: C₁₈H₃₅ClN₂O₆S
MW: 443 g/mol

ZX-030296

Lincomycin EP Impurity F

CAS: 14810-93-6
Formula: C₉H₁₉NO₅S
MW: 253.32 g/mol

ZX-030303

Liothyronine EP Impurity B (Dihydrate Salt)

CAS: 18835-59-1
Formula: C₉H₁₃I₂NO₅
MW: 469.01 g/mol

ZX-005803

Liothyronine EP Impurity B (Freebase)

CAS: 300-39-0
Formula: C₉H₉I₂NO₃
MW: 432.98 g/mol

ZX-005804

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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