Monograph |
Specified impurities |
Other detectable impurities |
Ph. Eur. 7.3-07/2011:1077 ‘Buserelin’ |
[2-D-histidine]buserelin |
- |
[4-D-serine]buserelin |
Buserelin-(3-9)-peptide |
[5-D-tyrosine]buserelin |
[1-(5-oxo-D-proline)]buserelin |
Ph. Eur. 7.3-01/2008:0471 ‘Calcitonin (salmon)’
USP33 p1747 |
Acetylcalcitonin (salmon) |
- |
[9-D-leucine]calcitonin (salmon) |
Des-22-tyrosine-calcitonin (salmon) |
O-acetylated calcitonin (salmon) |
Salmon calcitoninylglycine {rDNA only} |
[1,7-bis(3-sulpho-L-alanine]calcitonin (salmon) {rDNA only} |
[1,7-bis(3-sulpho-L-alanine]calcitoninylglycine (salmon) {rDNA only} |
Ph. Eur. 7.3-07/2009:0712 ‘Desmopressin’
USP33 p2075 |
-
Oxytocin |
[5-L-aspartic acid]desmopressin |
[4-L-glutamic acid]desmopressin |
[9-glycine]desmopressin |
[8-L-arginine]desmopressin |
N5.4-[(acetylamino)methyl]desmopressin |
N4.5-[(acetylamino)methyl]desmopressin |
N1.9,N1.9-dimethyldesmopressin |
R0-CEP 2002-058-Rev 00: Lipotec desmopressin
[valid = R1-CEP 2002-058-Rev 02 – BCN Peptides] |
[6-D-cysteine]desmopressin (0.5%) |
- |
aspartic acid-dehydrated desmopressin (0.5%) |
Ph. Eur. 7.3-01/2008:1634 ‘Felypressin’ |
S1,S6-bis[(acetylamino)methyl]-(reduced felypressin) |
- |
[5-aspartic acid]felypressin |
bis(reduced felypressin) (1,6’),(1’,6)-bis(disulfide) |
bis(reduced felypressin) (1,1’),(6’,6)-bis(disulfide) |
N1-acetylfelypressin |
[4-glutamic acid]felypressin |
Ph. Eur. 7.3-01/2008:0827 ‘Gonadorelin acetate’
USP33 p2519 |
- |
- |
Gonadorelin free acid |
R0-CEP 2005-022-Rev 00: Bachem gonadorelin acetate
[currently valid] |
[2-D-histidine]gonadorelin (0.5%) |
- |
[5-D-tyrosine]gonadorelin (0.5%) |
Ph. Eur. 7.3-01/2008:1636 ‘Goserelin’ |
[4-D-serine]goserelin |
- |
[6-[O-(1,1-dimethylethyl)-L-serine]goserelin |
[9-D-proline]goserelin |
1-carbomoylyl-2-[5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-O-(1,1-dimethylethyl)-D-seryl-L-leucyl-L-arginyl]diazane |
5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-O-(1,1-dimethylethyl)-D-seryl-L-leucyl-L-arginyl-L-prolinohydrazide |
[5-D-tyrosine]goserelin |
[2-D-histidine]goserelin |
[1-(5-oxo-D-proline)]goserelin |
endo-8a,8b-di-L-proline-goserelin |
endo-8a-L-proline-goserelin |
O4-acetylgoserelin |
[7-D-leucine]goserelin |
Ph. Eur. 7.3-01/2008:0907 ‘Gramicidin’
USP33 p2528 |
5-methyl-N-[2-(4-sulfamoylphenyl)-ethyl]pyrazine-2-carboxamide |
- |
cyclohexanamine |
Ethyl[2-[4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl]-ethyl]carbamate |
6-methyl-N-[2-(4-sulfamoylphenyl)-ethyl]pyrazine-2-carboxamide |
1-cyclohexyl-3-[[4-[2-[[(6-methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea |
Ethyl[2-(4-sulfamoylphenyl)ethyl]carbamate |
Methyl[[4-[2-[[(5-methylpyrazin-2-yl)carbonyl]amino]-ethyl]phenyl]sulfonyl]carbamate |
4-[2-[(cyclohexylcarbamoyl)amino]ethyl]-benzenesulfonamide |
N-(cylcohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)-amino]ethyl]benzensulfonamide |
Ph. Eur. 7.3-01/2008:1637 ‘Bovine insulin’
USP33 p2639 |
-
A-21 desamido insulin |
- |
Ph. Eur. 7.3-01/2011:0838 ‘Human insulin’
USP33 p2642
IP2010 |
- |
- |
A-21 desamido insulin |
- |
Ph. Eur. 7.3-01/2008:2085 ‘Insulin lispro’
USP33 p2644 |
- |
- |
A-21 desamido insulin lispro |
Ph. Eur. 7.3-01/2008:2084 ‘Insulin aspart’ |
- |
- |
Ph. Eur. 7.3-01/2008:1638 ‘Insulin porcine’
USP33 p2639 |
-
A-21 desamido insulin |
- |
Ph. Eur. 7.3-07/2010:2215 ‘Iodixanol’
USP33 p2660 |
- |
- |
Ph. Eur. 7.3-01/2008:1442 ‘Leuprorelin’
USP33 ‘Leuprolide’ p2761 |
[4-D-serine]leuprorelin |
[3-D-tryptophane]leuprorelin |
[2-D-histidine]leuprorelin |
[2-D-histidine,4-D-serline]leuprorelin |
[6-L-leucine]leuprorelin |
[5-D-tyrosine]leuprorelin |
[4-(O-acetyl-L-serine)]leuprorelin |
[7-D-leucine]leuprorelin |
|
[1-(5-oxo-D-proline]leuprorelin |
|
[8-[5-N-[imino(1H-pyrazol-1-yl)methyl]-L-ornithine]]leuprorelin |
|
[4-dehydroalanine]leuprorelin |
R0-CEP 2001-454-Rev 01: Bachem leuprorelin
[valid = R1-CEP 2001-454-Rev 01] |
Pyr-His-Trp-Ser-Tyr-OH (0.5%) |
|
des-Pro-NHEt9-leuprorelin (0.2%) |
unidentified impurity at RRT = 0.87 (0.2%) |
Ph. Eur. 7.3-01/2008:0780 ‘Oxytocin’
USP33 p3185
Ph. Int.
IP2010 |
- |
- |
- |
Carbimido oxytocin |
Acetyloxytocin |
Α-oxytocin dimer
Β-oxytocin dimer |
- |
Ph. Eur. 7.3-01/2008:1144 ‘Protirelin’ |
5-oxo-L-prolyl-D-histidyl-L-prolinamide |
- |
5-oxo-D-prolyl-L-histidyl-L-prolinamide |
5-oxo-L-prolyl-L-histidine |
5-oxo-L-prolyl-L-histidyl-L-proline |
cyclo(-L-histidyl-L-prolyl-) |
Ph. Eur. 7.3-01/2011:0949 ‘Somatostatin’ |
- |
- |
R0-CEP 2005-245-Rev 00: Bachem somatostatin
[currently valid] |
unidentified impurity at RRT = 0.68-0.72 (0.5%) |
- |
unidentified impurity at RRT = 0.77 (0.5%) |
unidentified impurity at RRT = 0.80 (0.5%) |
Somatostatin-(1-14)-peptide (0.5%) |
unidentified impurity at RRT = 0.92 (0.5%) |
[12-(O-acetyl-threonine)]somatostatin (0.5%) |
[13-(O-acetyl-L-serine)]somatostatin (0.8%) |
unidentified impurity at RRT = 1.31 (0.8%) |
(N-ε-acetyl-lysine)somatostatin (0.5%) |
unidentified impurity at RRT = 1.43 (0.5%) |
unidentified impurity at RRT = 1.65-1.74 (0.5%) |
Ph. Eur. 7.3-04/2010:0644 ‘Tetracosactide’ |
tetracosactide sulphoxide |
|
unidentified impurity at RRT = 0.95 |
Ph. Eur. 7.3-01/2011:0580 ‘Aprotinin’
USP33 p1575 |
Aprotinin-(1-56)-peptide |
Aprotinin-(1-57)-peptide |
(5-oxoprolyl)aprotinin |
des-Ala-des-Gly aprotinin |
des-Ala- aprotinin |
N-pyroglutamyl aprotinin |
Ph. Eur. 7.3-01/2008:1635‘Human glucagon’
USP33 p2504 |
- |
- |
Ph. Eur. 7.3-01/2008:0465‘Bacitracin’
USP33 p1620
IP 2010 |
Bacitracin F |
|
Impurity E |
IP2010: Bleomycin
USP33 p1693 |
Demethylbleomycin A2 |
|
Bleomycinic acid |
Bleomycin B4 |
USP33: ’Capreomycin’ p1777
IP2010 |
- |
|
IP2010:’ Cephalexin’
USP33 p1870 |
D-phenylglycine |
|
7- aminodesacetoxycephalosporanic acid |
cefotaxime |
USP33: ‘Dactinomycin’ p2053 |
- |
|
IP2010: Vasopressin
USP33 p3849 |
Oxytocin
- |
|
IP2010: Vancomycin
USP33 p3844 |
N-demethylvancomycin B |
|
aglucovancomycin B |
β-Asp3 vancomycin B |
desvancosaminylvancomycin B |
