Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C24H28N2O5.ClH |
Molecular Weight | 460.95 |
Optical Activity | ( - ) |
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=CC=CC=C3N(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 | ClH |
Molecular Weight | 36.461 |
Charge | 0 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
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 |
DescriptionSources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdfhttps://www.google.com/patents/WO2006084761A1 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf | http://usp35.infostar.com.cn/uspnf/pub/data/v35300/usp35nf30s0_m7495.htmlCurator'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
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdfhttps://www.google.com/patents/WO2006084761A1 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf | http://usp35.infostar.com.cn/uspnf/pub/data/v35300/usp35nf30s0_m7495.html
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 an impurity referred to as Related Compound B, which is a diastereomer of benazepril, an ACE inhibitor, under the brand name Lotensin used primarily in treatment of hypertension, congestive heart failure, and heart attacks, and also in preventing the renal and retinal complications of diabetes. BENAZEPRIL, (±)- is used as USP Reference Standard.
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL1808 |
14.0 nM [IC50] | ||
Target ID: CHEMBL1808 |
0.1 µM [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 |
|||
Primary | BENAZEPRIL HYDROCHLORIDE Approved UseBenazepril hydrochloride tablets are indicated for the treatment of hypertension. They
may be used alone or in combination with thiazide diuretics. 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 |
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 |
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 |
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 |
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 Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Dizziness postural | 2% | 5 mg 1 times / day multiple, oral Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy |
Dizziness | 2% | 5 mg 1 times / day multiple, oral Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy |
Headache | 6% | 5 mg 1 times / day multiple, oral Recommended Dose: 5 mg, 1 times / day Route: oral Route: multiple Dose: 5 mg, 1 times / day Sources: |
unhealthy |
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 |
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 |
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 |
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 |
PubMed
Title | Date | PubMed |
---|---|---|
Sympathomoderating influence of benazepril in essential hypertension. | 1992 Apr |
|
Short-term metabolic effects of the ACE-inhibitor benazepril in type 2 diabetes mellitus associated with arterial hypertension. | 1992 Jul-Aug |
|
[Serological study on inhibitory function of shenkang injection on glomerular mesangial cell]. | 2001 Jul |
|
[CEA comprehensive evaluation for Western and traditional Chinese hypotensive drugs]. | 2001 Sep |
|
[Effects of benazepril on apoptosis in the kidney of diabetic rats]. | 2002 Jun |
|
[Clinical observation on effect of shenle capsule in treating mesangial proliferating glomerulonephritis]. | 2002 May |
|
[Non-immunologic factor: immunosuppressive drug-induced nephrotoxicity]. | 2002 Nov |
|
The effects of antihypertensive agents on the survival rate of polycystic kidney disease in Han:SPRD rats. | 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 |
|
Optimisation by experimental design of a capillary electrophoretic method for the separation of several inhibitors of angiotensin-converting enzyme using alkylsulphonates. | 2002 Nov 29 |
|
Reoptimization of MDL keys for use in drug discovery. | 2002 Nov-Dec |
|
Effects of antihypertensive drugs on peritoneal vessels in hypertensive dogs with mild renal insufficiency. | 2003 |
|
ACE Inhibition with moexipril: a review of potential effects beyond blood pressure control. | 2003 |
|
[The use of angiotensin-converting enzyme inhibitor benazepril in acute period of myocardial infarction]. | 2003 |
|
[Comparative effectiveness of lotensin and capoten in patients with chronic cardiac failure]. | 2003 |
|
Effects of valsartan with or without benazepril on blood pressure, angiotensin II, and endoxin in patients with essential hypertension. | 2003 Apr |
|
Additive effect of ACE inhibition and angiotensin II receptor blockade in type I diabetic patients with diabetic nephropathy. | 2003 Apr |
|
Sialic acid 9-O-acetylesterase catalyzes the hydrolyzing reaction from alacepril to deacetylalacepril. | 2003 Aug |
|
Effect of benazepril amlodipine combination on fibrinolysis in hypertensive diabetic patients. | 2003 Aug |
|
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 |
|
Quantitative determination of benazepril and benazeprilat in human plasma by gas chromatography-mass spectrometry using automated 96-well disk plate solid-phase extraction for sample preparation. | 2003 Jan 5 |
|
Argyria associated with colloidal silver supplementation. | 2003 Jul |
|
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 |
|
An angiotensin converting enzyme inhibitor, benazepril can be transformed to an active metabolite, benazeprilat, by the liver of dogs with ascitic pulmonary heartworm disease. | 2003 Jun |
|
Results of a pilot pharmacotherapy quality improvement program using fixed-dose, combination amlodipine/benazepril antihypertensive therapy in a long-term care setting. | 2003 Jun |
|
[Study on candidate genes of benazepril related cough in Chinese hypertensives]. | 2003 Jun |
|
Pharmacokinetic/pharmacodynamic modelling of the disposition and effect of benazepril and benazeprilat in cats. | 2003 Jun |
|
Combination is better than monotherapy with ACE inhibitor or angiotensin receptor antagonist at recommended doses. | 2003 Mar |
|
Correlation of Angiotensin-converting enzyme gene polymorphism with effect of antihypertensive therapy by Angiotensin-converting enzyme inhibitor. | 2003 Mar |
|
Effects of combined ACE inhibitor and angiotensin II antagonist treatment in human chronic nephropathies. | 2003 Mar |
|
Effect of benazepril addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. | 2003 Mar |
|
[Postmarketing surveillance of benazepril-related cough and related risk factors analysis on hypertensives]. | 2003 May |
|
Achieving goal blood pressure in patients with type 2 diabetes: conventional versus fixed-dose combination approaches. | 2003 May-Jun |
|
Relationship between polymorphism of the angiotensin-converting enzyme gene and the response to angiotensin-converting enzyme inhibition in hypertensive patients. | 2003 Nov |
|
Adherence to antihypertensive therapy with fixed-dose amlodipine besylate/benazepril HCl versus comparable component-based therapy. | 2003 Nov-Dec |
|
By the way, doctor. After a recent blood pressure check, my doctor bumped up my dose of Lotensin [an ACE inhibitor] from 10 milligrams to 20. I had been taking the 10-mg pill in the morning, but my doctor advised me to take the new, higher dose in the evening. He said most strokes and heart attacks happen in the morning, and that I could get better protection by taking the drug right before. But I read in the Health Letter a couple of months ago that you recommend morning intake, so I am confused. | 2003 Oct |
|
[Vasopressin analogue injection as ultimate measure for counteracting severe catecholamine-refractory poisoning by several vasodilators taken with suicidal intent]. | 2003 Oct 17 |
|
Investigation of pimobendan versus benazepril in canine myxomatous valvular disease. | 2003 Oct 4 |
|
Angiotensin II inhibition increases cellular glucose transport during reperfusion but not ischemia in pig hearts. | 2003 Sep |
|
Systemic contact dermatitis due to captopril without cross-sensitivity to fosinopril, quinapril and benazepril. | 2004 |
|
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 |
|
Combined treatment with an AT1 receptor blocker and angiotensin converting enzyme inhibitor has an additive effect on inhibiting neointima formation via improvement of nitric oxide production and suppression of oxidative stress. | 2004 Feb |
|
Low-dose dual blockade of the renin-angiotensin system in patients with primary glomerulonephritis. | 2004 Feb |
|
Effect of antihypertensive monotherapy and combination therapy on arterial distensibility and left ventricular mass. | 2004 Jan |
|
Stampidine prevents mortality in an experimental mouse model of viral hemorrhagic fever caused by lassa virus. | 2004 Jan 13 |
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
Curator's Comment: In the isolated rabbit aorta the vasocontraction induced by PGF2 alpha was competitively antagonized at 10(-5)-10(-4) mol/l, while vascular responses induced by PGE1, PGE2 or PGI2 was inhibited at 3 x 10(-4) mol/l of benazepril. https://www.ncbi.nlm.nih.gov/pubmed/2080946
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
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Record UNII |
N1SN99T69T
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Validated (UNII)
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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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Related Record | Type | Details | ||
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BASIS OF STRENGTH->SUBSTANCE |
ASSAY (HPLC)
EP
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PARENT -> SALT/SOLVATE |
|
Related Record | Type | Details | ||
---|---|---|---|---|
|
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
|
||
|
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
|
||
|
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
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
For the calculation of content, multiply the peak area by 0.7
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 |
|
||
|
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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