PHR3002

Atazanavir Sulfate

pharmaceutical secondary standard, certified reference material

• Synonym(s): Atazanavir sulfate, (3S,8S,9S,12S)-1,14-Dimethyl-3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioate sulfate
• Empirical Formula (Hill Notation): C₃₈H₅₂N₆O₇ · H₂SO₄
• CAS Number: 229975-97-7
• Molecular Weight: 802.93
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0002059; traceable to USP 1044334
• API family: atazanavir
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• application(s): pharmaceutical
• storage temp.: 2-8°C
• SMILES string: O[C@@H](CN(CC1=CC=C(C2=CC=CC=N2)C=C1)NC([C@@H](NC(OC)=O)C(C)(C)C)=O)[C@@H](NC([C@@H](NC(OC)=O)C(C)(C)C)=O)CC3=CC=CC=C3.O=S(O)OO
• InChI: 1S/C38H52N6O7.H2O4S/c1-37(2,3)31(41-35(48)50-7)33(46)40-29(22-25-14-10-9-11-15-25)30(45)24-44(43-34(47)32(38(4,5)6)42-36(49)51-8)23-26-17-19-27(20-18-26)28-16-12-13-21-39-28;1-5(2,3)4/h9-21,29-32,45H,22-24H2,1-8H3,(H,40,46)(H,41,48)(H,42,49)(H,43,47);(H2,1,2,3,4)/t29-,30-,31+,32+;/m0./s1
• InChI key: DQSGVVGOPRWTKI-QVFAWCHISA-N

Description

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

Application

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.

Biochem/physiol Actions

Atazanavir sulfate is the prodrug of Atazanavir, an antiviral HIV protease inhibitor.

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.

Safety Information

• Pictograms: GHS08,GHS05
• Signal Word: Danger
• Hazard Statements: H318,H372
• Precautionary Statements: P260 - P264 - P270 - P280 - P305 + P351 + P338 - P314
• Hazard Classifications: Eye Dam. 1 - STOT RE 1
• Target Organs: Heart,Liver
• 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