PHR1422

Atorvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Atorvastatin hemicalcium salt sesquihydrate, 1H-Pyrrole-1-heptanoic acid, [R-(R*,R*)]-2-(4-flurophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl], calcium salt (2:1)
• Formule empirique (notation de Hill) : C₆₆H₆₈CaF₂N₄O₁₀ · 3H₂O
• Numéro CAS: 344423-98-9
• Poids moléculaire : 1209.39
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0001327; traceable to USP 1044516
• Famille d'API: atorvastatin
• CofA (certificat d'analyse): current certificate can be downloaded
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-30°C
• Chaîne SMILES: [Ca+2].Fc5ccc(cc5)c6[n](c(c(c6c8ccccc8)C(=O)Nc7ccccc7)C(C)C)CC[C@@H](O)C[C@@H](O)CC(=O)O.Fc1ccc(cc1)c2[n](c(c(c2c4ccccc4)\C(=N\c3ccccc3)\[O-])C(C)C)CC[C@@H](O)C[C@@H](O)CC(=O)[O-].O.O.O
• InChI: 1S/2C33H35FN2O5.Ca.3H2O/c2*1-21(2)31-30(33(41)35-25-11-7-4-8-12-25)29(22-9-5-3-6-10-22)32(23-13-15-24(34)16-14-23)36(31)18-17-26(37)19-27(38)20-28(39)40;;;;/h2*3-16,21,26-27,37-38H,17-20H2,1-2H3,(H,35,41)(H,39,40);;3*1H2/q;;+2;;;/p-2/t2*26-,27-;;;;/m11..../s1
• Clé InChI: SHZPNDRIDUBNMH-NIJVSVLQSA-L

Description

Description générale

Atorvastatin Calcium is a synthetic cholesterol lowering agent,[1] which acts as an inhibitor of 3-hydroxy-3-methyl glutaryl coenzyme A reductase. It is widely used in combination with amlodipine besylate as a medication in the treatment of vasospastic angina, hypertension, chronic stable angina and primary dysbetalipoproteinemia.[2]
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

Azathioprine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[2][1] using reversed-phase high-performance liquid chromatography (RP-HPLC)[2] and spectrophotometric techniques.[1]

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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAC0148 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analyte

Atorvastatin hemicalcium salt sesquihydrate

Informations sur la sécurité

• Pictogrammes: GHS08
• Mention d'avertissement: Danger
• Mentions de danger: H351,H360D
• Conseils de prudence: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Classification des risques: Carc. 2 - Repr. 1B
• Code de la classe de stockage: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable