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PHR1631

Supelco

Risperidone

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Risperidone, R 64,766
Empirical Formula (Hill Notation):
C23H27FN4O2
CAS Number:
Molecular Weight:
410.48
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 1137
traceable to Ph. Eur. R1000600
traceable to USP 1604654

API family

risperidone

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CC1=C(CCN2CCC(CC2)c3noc4cc(F)ccc34)C(=O)N5CCCCC5=N1

InChI

1S/C23H27FN4O2/c1-15-18(23(29)28-10-3-2-4-21(28)25-15)9-13-27-11-7-16(8-12-27)22-19-6-5-17(24)14-20(19)30-26-22/h5-6,14,16H,2-4,7-13H2,1H3

InChI key

RAPZEAPATHNIPO-UHFFFAOYSA-N

Gene Information

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1 of 4

This Item
R1000600BP1137BP1158
Risperidone Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1631

Risperidone

Risperidone European Pharmacopoeia (EP) Reference Standard

R1000600

Risperidone

Risperidone British Pharmacopoeia (BP) Reference Standard

BP1137

Risperidone

Risperidone impurity standard British Pharmacopoeia (BP) Reference Standard

BP1158

Risperidone impurity standard

packaging

pkg of 500 mg

packaging

-

packaging

-

packaging

-

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical

application(s)

pharmaceutical

format

neat

format

neat

format

neat

format

mixture

storage temp.

2-30°C

storage temp.

-

storage temp.

2-8°C

storage temp.

2-8°C

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards
Risperidone is a new central 5-hydroxytryptamine2 and dopamine D2 antagonist. It is used to treat agitation, aggression,and psychosis caused during demnetia. It is a neuroleptic drug. It is also an atypical antipsychotic drug which is used for treating schizophrenia.
Risperidone is a psychotropic agent, belonging to the chemical class of benzisoxazole derivatives and is commonly used for the treatment of schizophrenia.

Application

Risperidone may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using colorimetric technique and reversed-phase high-performance liquid chromatography technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC2895 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Pictograms

Skull and crossbones

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 3 Oral

Storage Class Code

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

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705578-5MG-PW

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MMYOMAG-74K-13

1000309185

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RP-HPLC estimation of risperidone in tablet dosage forms
Baldania.LS, et al.
Indian Journal of Pharmaceutical Sciences, 70(4), 494-494 (2008)
A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia.
Csernansky JG
The New England Journal of Medicine, 346(1), 16-22 (2002)
A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients.
Chouinard G
Journal of Clinical Psychopharmacology, 13(1), 25-40 (1993)
The D2 dopamine receptor occupancy of risperidone and its relationship to extrapyramidal symptoms: a PET study.
Kapur S
Life Sciences, 57(10), PL103-PL107 (1995)
A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia.
Brodaty H
The Journal of Clinical Psychiatry, 64(2), 134-143 (2003)

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