136590-28-8

Basic information

• Product Name: (βR,δR,1S,2S)-1,2-Dihydro-β,δ,6-trihydroxy-2-methyl-1-naphthaleneheptanoic Acid (Pravastatin Impurity)
• Synonyms: (βR,δR,1S,2S)-1,2-Dihydro-β,δ,6-trihydroxy-2-methyl-1-naphthaleneheptanoic Acid (Pravastatin Impurity);(βR,δR,1S,2S)-1,2-Dihydro-β,δ,6-trihydroxy-2-Methyl-1-naphthaleneheptanoic Acid SodiuM Salt (Pravastatin IMpurity);Pravastatin IMpurity G;(3R,5R)-3,5-dihydroxy-7-((1S,2S)-6-hydroxy-2-methyl-1,2-dihydronaphthalen-1-yl)heptanoate;Pravastatin Oxidation Impurity;Pravastatin EP Impurity G
• CAS NO: 136590-28-8
• Molecular Formula: C18H23NaO5
• Molecular Weight: 342.36199
• Product Categories: Aromatics;Intermediates & Fine Chemicals;Metabolites & Impurities;Pharmaceuticals
• Mol File: 136590-28-8.mol
• Article Data: 3

Chemical Properties

• Appearance: /
• Storage Temp.: -20°C Freezer, Under Inert Atmosphere
• Solubility: DMSO (Slightly), Methanol (Slightly), Water (Slightly)
• CAS DataBase Reference: (βR,δR,1S,2S)-1,2-Dihydro-β,δ,6-trihydroxy-2-methyl-1-naphthaleneheptanoic Acid (Pravastatin Impurity)(CAS DataBase Reference)
• NIST Chemistry Reference: (βR,δR,1S,2S)-1,2-Dihydro-β,δ,6-trihydroxy-2-methyl-1-naphthaleneheptanoic Acid (Pravastatin Impurity)(136590-28-8)
• EPA Substance Registry System: (βR,δR,1S,2S)-1,2-Dihydro-β,δ,6-trihydroxy-2-methyl-1-naphthaleneheptanoic Acid (Pravastatin Impurity)(136590-28-8)

Safety Data

• Hazardous Substances Data: 136590-28-8(Hazardous Substances Data)

Usage

Chemical Properties

Off-White Solid

Uses

Pravastatin impurity.

Upstream product

• 85956-22-5 pravastatin lactone 
• 81131-70-6 pravastatin sodium salt 

Relevant articles and documents

Selection of solid dosage form composition through drug-excipient compatibility testing

A drug-excipient compatibility screening model was developed by which potential stability problems due to interactions of drug substances with excipients in solid dosage forms can be predicted. The model involved storing drug-excipient blends with 20% added water in closed glass vials at 50 °C and analyzing them after 1 and 3 weeks for chemical and physical stability. The total weight of drug-excipient blend in a vial was usually kept at about 200 mg. The amount of drug substance in a blend was determined on the basis of the expected drug-to-excipient ratio in the final formulation. Potential roles of several key factors, such as the chemical nature of the excipient, drug-to-excipient ratio, moisture, microenvironmental pH of the drug- excipient mixture, temperature, and light, on dosage form stability could be identified by using the model. Certain physical changes, such as polymorphic conversion or change from crystalline to amorphous form, that could occur in drug-excipient mixtures were also studied. Selection of dosage form composition by using this model at the outset of a drug development program would lead to reduction of 'surprise' problems during long-term stability testing of drug products.

Preparation method of oxidation impurities of hypolipidemic drugs

The invention discloses a preparation method of oxidation impurities of hypolipidemic drugs. The invention provides a preparation method of a phenol compound as shown in a formula III. The method comprises the following steps: (1) in a solvent and in the presence of acid, carrying out cyclization reaction as shown in the specification on a crude product of a sodium salt of a phenol compound as shown in a formula III' to obtain a phenol compound as shown in a formula IV; and (2) in a solvent, in the presence of alkali, carrying out a lactone ring-opening-salt forming reaction as shown in the specification on the phenol compound as shown in the formula IV to obtain the phenol compound as shown in the formula III. According to the preparation method, the pravastatin sodium oxide impurity with high purity can be obtained, the pravastatin sodium oxide impurity is used for product quality control, and the medication safety is improved.