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PHR1734

Supelco

Ritonavir

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Ritonavir, 10-Hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*, 8R*, 10R*, 11R*)], 1,3-Thiazol-5-ylmethyl N-[(2S,3S,5S)-3-hydroxy-5-[[(2S)-3-methyl-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-diphenylhexan-2-yl]carbamate

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About This Item

Empirical Formula (Hill Notation):
C37H48N6O5S2
CAS Number:
Molecular Weight:
720.94
UNSPSC Code:
41116107
NACRES:
NA.24

biological source

synthetic

Quality Level

grade

certified reference material
pharmaceutical secondary standard

Agency

BP
EP
USP
traceable to Ph. Eur. Y0000714
traceable to USP 1604803

vapor pressure

<0.0000001 kPa ( 25 °C)

API family

ritonavir

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

protect from light

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

color

white to tan

solubility

acetonitrile: slightly soluble
ethanol: freely soluble
methanol: freely soluble
methylene chloride: freely soluble
water: practically insoluble

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-30°C

InChI

1S/C37H48N6O5S2/c1-24(2)33(42-36(46)43(5)20-29-22-49-35(40-29)25(3)4)34(45)39-28(16-26-12-8-6-9-13-26)18-32(44)31(17-27-14-10-7-11-15-27)41-37(47)48-21-30-19-38-23-50-30/h6-15,19,22-25,28,31-33,44H,16-18,20-21H2,1-5H3,(H,39,45)(H,41,47)(H,42,46)/t28-,31-,32-,33-/m0/s1

InChI key

NCDNCNXCDXHOMX-XGKFQTDJSA-N

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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
Ritonavir belongs to the group of protease inhibitors, which block the part of HIV called protease. Its mode of action involves binding to the protease active site and inhibiting the activity of the enzyme.

Application

Ritonavir may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques.
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 LRAB9120 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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RP-HPLC method development and validation for simultaneous estimation of lopinavir and ritonavir in dosage form and in plasma
Kumar VK, et al.
International Journal of Pharmaceutical Sciences Review and Research, 3, 1-8 (2014)
HPTLC method for simultaneous determination of lopinavir and ritonavir in capsule dosage form
Sulebhavikar VA, et al.
Journal of Chemistry, 5(4), 706-712 (2008)

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