Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C24H28N2O5.ClH |
Molecular Weight | 460.95 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
Cl.CCOC(=O)[C@H](CCC1=CC=CC=C1)N[C@H]2CCC3=C(C=CC=C3)N(CC(O)=O)C2=O
InChI
InChIKey=VPSRQEHTHIMDQM-FKLPMGAJSA-N
InChI=1S/C24H28N2O5.ClH/c1-2-31-24(30)20(14-12-17-8-4-3-5-9-17)25-19-15-13-18-10-6-7-11-21(18)26(23(19)29)16-22(27)28;/h3-11,19-20,25H,2,12-16H2,1H3,(H,27,28);1H/t19-,20-;/m0./s1
Molecular Formula | C24H28N2O5 |
Molecular Weight | 424.4895 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
Molecular Formula | ClH |
Molecular Weight | 36.461 |
Charge | 0 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
DescriptionCurator's Comment: description was created based on several sources, including:
https://www.drugs.com/pro/benazepril.html | DOI: 10.1111/j.1527-3466.1990.tb00432.x
Curator's Comment: description was created based on several sources, including:
https://www.drugs.com/pro/benazepril.html | DOI: 10.1111/j.1527-3466.1990.tb00432.x
Benazepril is a prodrug which is metabolized by the liver into its active form benazeprilat via cleavage of the drug's ester group. Benazepril and Benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. Benazeprilat has much greater ACE inhibitory activity than does Benazepril. It is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Adverse reactions reported in controlled clinical trials and rarer events seen in post-marketing experience, include the following: Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing, nausea, pancreatitis, constipation, gastritis, vomiting, and melena, thrombocytopenia and hemolytic anemia, anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia. Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Benazepril. Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors (including benazepril) during therapy with lithium.
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL1808 |
14.0 nM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | LOTENSIN Approved UseAmlodipine besylate and benazepril hydrochloride capsules is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1) 1.1 Hypertension Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. Launch Date1991 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
437 pmol/g EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/2344861 |
10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered: |
BENAZEPRIL plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
334 pmol × h/g EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/2344861 |
10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered: |
BENAZEPRIL plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
0.6 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/2344861 |
10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered: |
BENAZEPRIL plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Other AEs: Headache, Back pain... Other AEs: Headache (8.6%) Sources: Back pain (2.6%) Diarrhoea (0.9%) Upper respiratory tract infection (3.4%) Peripheral oedema (1.7%) Sinusitis (1.7%) Fatigue (0.9%) Cough (1.7%) Arthralgia (0.9%) |
10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy n = 193 Health Status: unhealthy Condition: Essential hypertension Population Size: 193 Sources: |
Other AEs: Headache, Fatigue... Other AEs: Headache (9%) Sources: Fatigue (2%) Nausea (2%) Dizziness (2%) Cough increased (2%) |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Other AEs: Headache, Fatigue... Other AEs: Headache (3%) Sources: Fatigue (2%) Nausea (1%) Dizziness (3%) Dizziness postural (1%) Cough increased (2%) |
40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Other AEs: Headache, Fatigue... Other AEs: Headache (3%) Sources: Fatigue (2%) Nausea (1%) Dizziness (2%) Dizziness postural (1%) Cough increased (1%) |
5 mg 1 times / day multiple, oral (max) Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy n = 184 Health Status: unhealthy Condition: Essential hypertension Population Size: 184 Sources: |
Other AEs: Headache, Dizziness... Other AEs: Headache (6%) Sources: Dizziness (2%) Dizziness postural (2%) |
80 mg 1 times / day multiple, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: multiple Dose: 80 mg, 1 times / day Sources: |
unhealthy n = 86 Health Status: unhealthy Condition: Essential hypertension Population Size: 86 Sources: |
Other AEs: Headache, Fatigue... Other AEs: Headache (2%) Sources: Fatigue (5%) Nausea (1%) Cough increased (1%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Arthralgia | 0.9% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Diarrhoea | 0.9% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Fatigue | 0.9% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Cough | 1.7% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Peripheral oedema | 1.7% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Sinusitis | 1.7% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Back pain | 2.6% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Upper respiratory tract infection | 3.4% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Headache | 8.6% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy, adult n = 116 Health Status: unhealthy Condition: Essential hypertension Age Group: adult Population Size: 116 Sources: |
Cough increased | 2% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy n = 193 Health Status: unhealthy Condition: Essential hypertension Population Size: 193 Sources: |
Dizziness | 2% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy n = 193 Health Status: unhealthy Condition: Essential hypertension Population Size: 193 Sources: |
Fatigue | 2% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy n = 193 Health Status: unhealthy Condition: Essential hypertension Population Size: 193 Sources: |
Nausea | 2% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy n = 193 Health Status: unhealthy Condition: Essential hypertension Population Size: 193 Sources: |
Headache | 9% | 10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: |
unhealthy n = 193 Health Status: unhealthy Condition: Essential hypertension Population Size: 193 Sources: |
Dizziness postural | 1% | 20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Nausea | 1% | 20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Cough increased | 2% | 20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Fatigue | 2% | 20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Dizziness | 3% | 20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Headache | 3% | 20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 1145 Health Status: unhealthy Condition: Essential hypertension Population Size: 1145 Sources: |
Cough increased | 1% | 40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Dizziness postural | 1% | 40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Nausea | 1% | 40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Dizziness | 2% | 40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Fatigue | 2% | 40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Headache | 3% | 40 mg 1 times / day multiple, oral Recommended Dose: 40 mg, 1 times / day Route: oral Route: multiple Dose: 40 mg, 1 times / day Sources: |
unhealthy n = 771 Health Status: unhealthy Condition: Essential hypertension Population Size: 771 Sources: |
Dizziness postural | 2% | 5 mg 1 times / day multiple, oral (max) Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy n = 184 Health Status: unhealthy Condition: Essential hypertension Population Size: 184 Sources: |
Dizziness | 2% | 5 mg 1 times / day multiple, oral (max) Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy n = 184 Health Status: unhealthy Condition: Essential hypertension Population Size: 184 Sources: |
Headache | 6% | 5 mg 1 times / day multiple, oral (max) Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy n = 184 Health Status: unhealthy Condition: Essential hypertension Population Size: 184 Sources: |
Cough increased | 1% | 80 mg 1 times / day multiple, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: multiple Dose: 80 mg, 1 times / day Sources: |
unhealthy n = 86 Health Status: unhealthy Condition: Essential hypertension Population Size: 86 Sources: |
Nausea | 1% | 80 mg 1 times / day multiple, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: multiple Dose: 80 mg, 1 times / day Sources: |
unhealthy n = 86 Health Status: unhealthy Condition: Essential hypertension Population Size: 86 Sources: |
Headache | 2% | 80 mg 1 times / day multiple, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: multiple Dose: 80 mg, 1 times / day Sources: |
unhealthy n = 86 Health Status: unhealthy Condition: Essential hypertension Population Size: 86 Sources: |
Fatigue | 5% | 80 mg 1 times / day multiple, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: multiple Dose: 80 mg, 1 times / day Sources: |
unhealthy n = 86 Health Status: unhealthy Condition: Essential hypertension Population Size: 86 Sources: |
PubMed
Title | Date | PubMed |
---|---|---|
Benazepril versus felodipine as supplement to bendroflumethiazide: evaluation by office and ambulatory blood pressure. | 1998 Apr |
|
ACE DD genotype is more susceptible than ACE II and ID genotypes to the antiproteinuric effect of ACE inhibitors in patients with proteinuric non-insulin-dependent diabetes mellitus. | 2000 Oct |
|
Voltammetric determination of benazepril and ramipril in dosage forms and biological fluids through nitrosation. | 2001 Jan-Feb |
|
[Serological study on inhibitory function of shenkang injection on glomerular mesangial cell]. | 2001 Jul |
|
Cilnidipine is as effective as benazepril for control of blood pressure and proteinuria in hypertensive patients with benign nephrosclerosis. | 2001 Jul |
|
Valsartan alone or with a diuretic or ACE inhibitor as treatment for African American hypertensives: relation to salt intake. | 2001 Jul |
|
The quantitative determination of several inhibitors of the angiotensin-converting enzyme by CE. | 2001 Jul |
|
Comparison of the effects of an ACE inhibitor and alphabeta blocker on the progression of renal failure with left ventricular hypertrophy: preliminary report. | 2001 Mar |
|
Prescribing patterns and cost of antihypertensive drugs in an internal medicine clinic. | 2001 May-Jun |
|
[CEA comprehensive evaluation for Western and traditional Chinese hypotensive drugs]. | 2001 Sep |
|
Pilot study to evaluate a water displacement technique to compare effects of diuretics and ACE inhibitors to alleviate lower extremity edema due to dihydropyridine calcium antagonists. | 2001 Sep |
|
Valsartan/hydrochlorothiazide: a review of its pharmacology, therapeutic efficacy and place in the management of hypertension. | 2002 |
|
Clinical pharmacokinetics and selective pharmacodynamics of new angiotensin converting enzyme inhibitors: an update. | 2002 |
|
Using ACE inhibitors appropriately. | 2002 Aug 1 |
|
[Effects of benazepril on apoptosis in the kidney of diabetic rats]. | 2002 Jun |
|
Comparison of benazepril-amlodipine and captopril-thiazide combinations in the management of mild-to-moderate hypertension. | 2002 Jun |
|
Combination therapy of amlodipine/benazepril versus monotherapy of amlodipine in a practice-based setting. | 2002 Jun |
|
Combination therapy with benazepril and oral adsorbent ameliorates progressive renal fibrosis in uremic rats. | 2002 Mar |
|
[Non-immunologic factor: immunosuppressive drug-induced nephrotoxicity]. | 2002 Nov |
|
Selection of the dose of angiotensin converting enzyme inhibitor for patients with diabetic nephropathy depends on the presence or absence of left ventricular hypertrophy. | 2002 Nov |
|
Reoptimization of MDL keys for use in drug discovery. | 2002 Nov-Dec |
|
Effect of renal insufficiency on the pharmacokinetics and pharmacodynamics of benazepril in cats. | 2002 Oct |
|
Rhabdomyolysis with concurrent atorvastatin and diltiazem. | 2002 Oct |
|
[The use of angiotensin-converting enzyme inhibitor benazepril in acute period of myocardial infarction]. | 2003 |
|
Gene expression profile revealed different effects of angiotensin II receptor blockade and angiotensin-converting enzyme inhibitor on heart failure. | 2003 Dec |
|
[Effect of the compound of traditional Chinese drugs on gene expression of renal endothelin and its receptor of experimental diabetic nephropathy]. | 2003 Feb |
|
Linear IgA dermatosis induced by a new angiotensin-converting enzyme inhibitor. | 2003 Feb |
|
The first hypertension trial comparing the effects of two fixed-dose combination therapy regimens on cardiovascular events: Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH). | 2003 Jul-Aug |
|
Rationale for combination therapy as initial treatment for hypertension. | 2003 Jul-Aug |
|
Using the electronic medical record to enhance the use of combination drugs. | 2003 Jul-Aug |
|
Correlation of Angiotensin-converting enzyme gene polymorphism with effect of antihypertensive therapy by Angiotensin-converting enzyme inhibitor. | 2003 Mar |
|
Achieving goal blood pressure in patients with type 2 diabetes: conventional versus fixed-dose combination approaches. | 2003 May-Jun |
|
Angiotensin II inhibition increases cellular glucose transport during reperfusion but not ischemia in pig hearts. | 2003 Sep |
|
Effects of co-administration of urokinase and benazepril on severe IgA nephropathy. | 2004 Apr |
|
Hypertensive patients from two rural Chinese counties respond differently to benazepril: the Anhui Hypertension Health Care Study. | 2004 Feb |
|
Effect of antihypertensive monotherapy and combination therapy on arterial distensibility and left ventricular mass. | 2004 Jan |
Patents
Sample Use Guides
The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20-40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited.
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/3140614
Benazepril inhibited both adrenaline-stimulated aortic PGI2 synthesis (25 pg mg -1 min-1) and carbachol-stimulated urinary bladder PGI2 synthesis (20 pg mg -1 min-1) in dose-dependent manners. IC50 (concentrations of antagonist at which agonist-stimulated PGI2 synthesis was inhibited by 50%) was 8 x 10-5.
Substance Class |
Chemical
Created
by
admin
on
Edited
Fri Dec 15 16:19:37 GMT 2023
by
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on
Fri Dec 15 16:19:37 GMT 2023
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Record UNII |
N1SN99T69T
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Record Status |
Validated (UNII)
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Record Version |
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EMA VETERINARY ASSESSMENT REPORTS |
FORTEKOR PLUS (AUTHORISED)
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NCI_THESAURUS |
C247
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EMA VETERINARY ASSESSMENT REPORTS |
CARDALIS (AUTHORIZED)
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m2303
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Related Record | Type | Details | ||
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BASIS OF STRENGTH->SUBSTANCE |
ASSAY (HPLC)
EP
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PARENT -> SALT/SOLVATE |
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Related Record | Type | Details | ||
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IMPURITY -> PARENT |
Impurity B: not more than 2.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.5 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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||
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IMPURITY -> PARENT |
Impurity F: not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
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IMPURITY -> PARENT |
Impurity E: not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
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IMPURITY -> PARENT |
For the calculation of content, multiply the peak area by 0.7
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
Impurity D: not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
Impurity G: not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
Impurity C: not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.3 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
For the calculation of content, multiply the peak area by 0.5.
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
Related Record | Type | Details | ||
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ACTIVE MOIETY |
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