U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C30H45NO7P.Na
Molecular Weight 585.6443
Optical Activity UNSPECIFIED
Defined Stereocenters 4 / 4
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of FOSINOPRIL SODIUM

SMILES

[Na+].CCC(=O)O[C@@H](O[P@](=O)(CCCCC1=CC=CC=C1)CC(=O)N2C[C@@H](C[C@H]2C([O-])=O)C3CCCCC3)C(C)C

InChI

InChIKey=TVTJZMHAIQQZTL-WATAJHSMSA-M
InChI=1S/C30H46NO7P.Na/c1-4-28(33)37-30(22(2)3)38-39(36,18-12-11-15-23-13-7-5-8-14-23)21-27(32)31-20-25(19-26(31)29(34)35)24-16-9-6-10-17-24;/h5,7-8,13-14,22,24-26,30H,4,6,9-12,15-21H2,1-3H3,(H,34,35);/q;+1/p-1/t25-,26+,30+,39-;/m1./s1

HIDE SMILES / InChI

Molecular Formula C30H45NO7P
Molecular Weight 562.6546
Charge -1
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 4 / 4
E/Z Centers 0
Optical Activity UNSPECIFIED

Molecular Formula Na
Molecular Weight 22.9898
Charge 1
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: Description was created based on several sources, including https://www.drugs.com/pro/fosinopril.html

Fosinopril is a phosphinic acid-containing ester prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is rapidly hydrolyzed to fosinoprilat, its principle active metabolite. Fosinoprilat inhibits ACE, the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Fosinopril may be used to treat mild to moderate hypertension, as an adjunct in the treatment of congestive heart failure, and to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy.

CNS Activity

Curator's Comment: Fosinopril does not cross the blood-brain barrier.

Originator

Curator's Comment: # Bristol-Myers Squibb

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
1.0 nM [IC50]
Target ID: P12822
Gene ID: 1.00009272E8
Gene Symbol: ACE
Target Organism: Oryctolagus cuniculus (Rabbit)
11.0 nM [IC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
FOSINOPRIL SODIUM

Approved Use

Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis

Launch Date

2003
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1556 ng/mL
7.5 mg single, intravenous
dose: 7.5 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
112 ng/mL
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
533 ng/mL
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
711 ng/mL
40 mg 2 times / day steady-state, oral
dose: 40 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
1018 ng/mL
80 mg single, oral
dose: 80 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
1217 ng/mL
80 mg 2 times / day steady-state, oral
dose: 80 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
131 ng/mL
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
5598 ng/mL
640 mg single, oral
dose: 640 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
3302 ng × h/mL
7.5 mg single, intravenous
dose: 7.5 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
920 ng × h/mL
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
3.3 μg × h/mL
40 mg single, oral
dose: 40 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
4.9 μg × h/mL
40 mg 2 times / day steady-state, oral
dose: 40 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
5.6 μg × h/mL
80 mg single, oral
dose: 80 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
7.5 μg × h/mL
80 mg 2 times / day steady-state, oral
dose: 80 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
1.1 μg × h/mL
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
58.3 μg × h/mL
640 mg single, oral
dose: 640 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
3.7 h
7.5 mg single, intravenous
dose: 7.5 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
4.3 h
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
5%
7.5 mg single, intravenous
dose: 7.5 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
8%
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
FOSINOPRILAT plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
80 mg 1 times / day multiple, oral
Highest studied dose
Dose: 80 mg, 1 times / day
Route: oral
Route: multiple
Dose: 80 mg, 1 times / day
Sources:
unhealthy, 28 - 68years
n = 12
Health Status: unhealthy
Condition: essential hypertension
Age Group: 28 - 68years
Sex: M+F
Population Size: 12
Sources:
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: Page: 16
unhealthy, >65 years
n = 688
Health Status: unhealthy
Condition: hypertension
Age Group: >65 years
Sex: unknown
Population Size: 688
Sources: Page: 16
Disc. AE: Headache, Transaminases increased...
AEs leading to
discontinuation/dose reduction:
Headache (0.4 - 0.9)
Transaminases increased (0.4 - 0.9)
Fatigue (0.4 - 0.9)
Cough (0.4 - 0.9)
Sources: Page: 16
40 mg 1 times / day steady, oral
MTD
Dose: 40 mg, 1 times / day
Route: oral
Route: steady
Dose: 40 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Condition: hypertension
Age Group: adult
Sex: unknown
Sources:
AEs

AEs

AESignificanceDosePopulation
Cough 0.4 - 0.9
Disc. AE
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: Page: 16
unhealthy, >65 years
n = 688
Health Status: unhealthy
Condition: hypertension
Age Group: >65 years
Sex: unknown
Population Size: 688
Sources: Page: 16
Fatigue 0.4 - 0.9
Disc. AE
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: Page: 16
unhealthy, >65 years
n = 688
Health Status: unhealthy
Condition: hypertension
Age Group: >65 years
Sex: unknown
Population Size: 688
Sources: Page: 16
Headache 0.4 - 0.9
Disc. AE
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: Page: 16
unhealthy, >65 years
n = 688
Health Status: unhealthy
Condition: hypertension
Age Group: >65 years
Sex: unknown
Population Size: 688
Sources: Page: 16
Transaminases increased 0.4 - 0.9
Disc. AE
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: Page: 16
unhealthy, >65 years
n = 688
Health Status: unhealthy
Condition: hypertension
Age Group: >65 years
Sex: unknown
Population Size: 688
Sources: Page: 16
PubMed

PubMed

TitleDatePubMed
Effect of valsartan and fosinopril on catecholamine-induced cardiac hypertrophy.
2000 Sep
[Effects of lorsartan, fosinopril on myocardial fibrosis, angiotensin II and cardiac remolding in hypertensive rats].
2001 Apr 28
Endogenous natriuretic peptides participate in renal and humoral actions of acute vasopeptidase inhibition in experimental mild heart failure.
2001 Aug
[Effectiveness and tolerance of fosinopril in the treatment of arterial hypertension of mild and medium severity].
2001 Dec
Simultaneous determination of hydrochlorothiazide and several inhibitors of angiotensin-converting enzyme by capillary electrophoresis.
2001 Jul 27
Fosinopril-induced prolonged cholestatic jaundice and pruritus: first case report.
2001 Mar
Effects of combination of angiotensin-converting enzyme inhibitor and angiotensin receptor antagonist on inflammatory cellular infiltration and myocardial interstitial fibrosis after acute myocardial infarction.
2001 Oct
[Changes of distensibility of the aorta in elderly patients during long-term therapy with various classes of hypotensive drugs (magnetic resonance tomography data)].
2002
Regression of ventricular and vascular hypertrophy: are there differences between structurally different angiotensin-converting enzyme inhibitors?
2002 Dec
[Effect of Erigeron breviscapus injection on ventricular and vascular remodeling in spontaneous hypertension rats].
2002 Feb
[Renoprotective effect of monopril in patients with diabetes mellitus in the preclinical stage of diabetic nephropathy].
2002 Jul-Sep
Safe drug prescribing.
2002 Jun 25
Fixed combinations of delapril plus indapamide vs fosinopril plus hydrochlorothiazide in mild to moderate essential hypertension.
2002 May-Jun
Hemodynamic and humoral effects of vasopeptidase inhibition in canine hypertension.
2002 Oct
Gateways to Clinical Trials.
2002 Sep
[Efficacy of combined use of fosinopril and propranolol in acute myocardial infarction].
2003
[Tongue angioedema associated with angiotensin-converting enzyme inhibitor (diagnosis, differential diagnosis, treatment)].
2003
Comparison of dipyridamole and fosinopril on renal progression in nephrectomized rats.
2003 Apr
Acute visual loss after initiation of antihypertensive therapy: case report.
2003 Aug 19
Effects of fosinopril and valsartan on expressions of ICAM-1 and NO in human umbilical vein endothelial cells.
2003 Jun
Effect of xuezhikang, a cholestin extract, on reflecting postprandial triglyceridemia after a high-fat meal in patients with coronary heart disease.
2003 Jun
ANP but not BNP reflects early left diastolic dysfunction in type 1 diabetics with myocardial dysinnervation.
2003 May
Effect of dual angiotensin converting enzyme/neutral endopeptidase inhibition, angiotensin converting enzyme inhibition, or AT1 antagonism on coronary microvasculature in spontaneously hypertensive rats.
2003 Nov
Angiotensin-converting enzyme inhibition but not angiotensin II receptor blockade regulates matrix metalloproteinase activity in patients with glomerulonephritis.
2003 Nov
Ramipril-associated hepatotoxicity.
2003 Nov
Protection of organic trauma in sinoaortic-denervated rats treated with fosinopril.
2003 Oct
Introduction to monitoring. What is what you prescribed actually doing?
2003 Oct
Dual renin-angiotensin system blockade restores blood pressure-renin dependency in individuals with low renin concentrations.
2003 Oct
Long-term renal survival in HIV-associated nephropathy with angiotensin-converting enzyme inhibition.
2003 Oct
[Combination therapy with losartan and fosinopril for early diabetic nephropathy].
2003 Sep
Comparative metabolic effects of hydrochlorothiazide and indapamide in hypertensive diabetic patients receiving ACE inhibitor therapy.
2003 Sep
Precipitation of PTSD with metoprolol for hypertension.
2003 Sep-Oct
Systemic contact dermatitis due to captopril without cross-sensitivity to fosinopril, quinapril and benazepril.
2004
American Heart Association scientific sessions.
2004 Apr
Clinical trials update from the European Society of Cardiology Heart Failure meeting: SHAPE, BRING-UP 2 VAS, COLA II, FOSIDIAL, BETACAR, CASINO and meta-analysis of cardiac resynchronisation therapy.
2004 Aug
Studies on the glycemic and lipidemic effect of monopril and losartan in normal and diabetic rats.
2004 Aug
Heart failure and first dose hypotension after angiotensin converting enzyme inhibitors.
2004 Dec
[Changes of collagen expression of pulmonary arteries and heart ventricles and intervention of fosinopril and losartan in rats with heart failure].
2004 Dec 2
Cardiorenal protective effects of vasopeptidase inhibition with omapatrilat in hypertensive transgenic (mREN-2)27 rats.
2004 Jan
Fosinopril and amlodipine in the treatment of isolated systolic hypertension.
2004 Jan-Feb
Comparative effects of fosinopril and irbesartan on hematopoiesis in essential hypertensives.
2004 Jul
Mortality rates in elderly patients who take different angiotensin-converting enzyme inhibitors after acute myocardial infarction: a class effect?
2004 Jul 20
Normalization of renal aquaporin-2 water channel expression by fosinopril, valsartan, and combination therapy in congestive heart failure: a new mechanism of action.
2004 Mar
Role of Angiotensin-converting enzyme and neutral endopeptidase in flow-dependent remodeling.
2004 Mar-Apr
Possible induction of diabetes by treatment of hypertension with indapamide (with four case reports).
2004 Sep
Therapeutic approaches in the prevention of cardiovascular disease in metabolic syndrome and in patients with type 2 diabetes.
2004 Sep
Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children?
2004 Sep
Lithium toxicity after switch from fosinopril to lisinopril.
2005 Mar
Patents

Sample Use Guides

Usual Adult Dose for Hypertension Initial dose: 10 mg orally once a day alone or in combination with a diuretic Maintenance dose: 20 to 40 mg orally once a day; some patients may have further response at 80 mg once a day Usual Adult Dose for Congestive Heart Failure Initial dose: 10 mg orally once a day Target dose range: 20 to 40 mg orally once a day Maximum dose: 40 mg orally once a day
Route of Administration: Oral
Fosinopril up-regulated klotho mRNA in NRK-52E cells pretreated with Fos(10(-5) mol/L) for 12 h incubated with AngII
Substance Class Chemical
Created
by admin
on Fri Dec 15 15:24:04 GMT 2023
Edited
by admin
on Fri Dec 15 15:24:04 GMT 2023
Record UNII
NW2RTH6T2N
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
FOSINOPRIL SODIUM
EP   MART.   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD  
USAN  
Official Name English
FOSINOPRIL SODIUM SALT [MI]
Common Name English
FOSINOPRIL SODIUM [VANDF]
Common Name English
MONOPRIL
Brand Name English
(4S)-4-CYCLOHEXYL-1-((R)-((S)-1-HYDROXY-2-METHYLPROPOXY)(4-PHENYLBUTYL)PHOSPHINYL)ACETYL-L-PROLINE PROPIONATE (ESTER), SODIUM SALT
Common Name English
FOSINOPRIL SODIUM SALT
MI  
Common Name English
Fosinopril sodium [WHO-DD]
Common Name English
FOSINOPRIL SODIUM COMPONENT OF MONOPRIL HCT
Common Name English
SQ 28555
Code English
FOSINOPRIL SODIUM [EP MONOGRAPH]
Common Name English
FOSINOPRIL SODIUM [USAN]
Common Name English
FOSINOPRIL SODIUM [USP MONOGRAPH]
Common Name English
FOSINOPRIL SODIUM [MART.]
Common Name English
SQ-28555
Code English
MONOPRIL HCT COMPONENT FOSINOPRIL SODIUM
Common Name English
FOSINOPRIL SODIUM [USP-RS]
Common Name English
L-PROLINE, 4-CYCLOHEXYL-1-(((2-METHYL-1-(1-OXOPROPOXY)PROPOXY)(4-PHENYLBUTYL)PHOSPHINYL)ACETYL)-, SODIUM SALT, (1(S*(R*)),2.ALPHA.,4.BETA.)-
Common Name English
FOSINOPRIL SODIUM [USP IMPURITY]
Common Name English
FOSINOPRIL SODIUM [ORANGE BOOK]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C247
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
Code System Code Type Description
ChEMBL
CHEMBL3039598
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
FDA UNII
NW2RTH6T2N
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
USAN
W-66
Created by admin on Fri Dec 15 15:24:05 GMT 2023 , Edited by admin on Fri Dec 15 15:24:05 GMT 2023
PRIMARY
MERCK INDEX
m5553
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY Merck Index
DAILYMED
NW2RTH6T2N
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
EVMPD
SUB02265MIG
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
PUBCHEM
49800050
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
CAS
88889-14-9
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
RXCUI
227278
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY RxNorm
CHEBI
5164
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
DRUG BANK
DBSALT000193
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
NCI_THESAURUS
C47542
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
EPA CompTox
DTXSID7046621
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
RS_ITEM_NUM
1283404
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
SMS_ID
100000092343
Created by admin on Fri Dec 15 15:24:04 GMT 2023 , Edited by admin on Fri Dec 15 15:24:04 GMT 2023
PRIMARY
Related Record Type Details
PARENT -> SALT/SOLVATE
Related Record Type Details
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
sum of impurities B, E and H: not more than 10 times the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent.)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
sum of impurities B, E and H: not more than 10 times the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
IMPURITY -> PARENT
IMPURITY -> PARENT
sum of impurities B, E and H: not more than 10 times the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
if present
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Related Record Type Details
ACTIVE MOIETY