Raloxifene analysis

The Raloxifene Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of raloxifene in oral dosage forms and raw active pharmaceutical ingredient (API) powders.

The analysis is suitable for pills, tablets, and capsules, with results reported in milligrams per tablet or capsule. Raw API powders can be evaluated by percentage content, with optional purity reporting in % (m/m).

About Raloxifene 

Raloxifene, also marketed under names such as Evista and Raloxo, is an orally active, non-steroidal selective estrogen receptor modulator (SERM). It acts as an estrogen agonist in some tissues and as an antagonist in others.

Raloxifene is used clinically for the prevention and treatment of osteoporosis in postmenopausal women and for reducing the risk of invasive breast cancer in selected postmenopausal patients.

Key Features

• Targeted identification and quantification of raloxifene
• Suitable for pills, tablets, capsules, and raw API powders
• Analysis by HPLC
• Results for oral products reported in mg per tablet or capsule
• Results for raw API powders reported as percentage content
• Optional purity reporting in % (m/m) for raw API powders
• Minimum sample amount of three tablets or capsules
• Minimum sample amount of 200 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compound: Raloxifene
• Other names: Evista, Raloxo
• CAS number: 84449-90-1
• Testing method: HPLC
• Minimum amount of target compound for evaluation in oral products: 5 mg per pill, tablet, or capsule
• Minimum content of target compound for evaluation in raw API powders: 10%
• Result format for oral products: mg per tablet or capsule
• Result format for raw API powders: % [98%+, 96%+ or % value such as 94.15%]
• Minimum sample amount for oral products: Three tablets or capsules
• Minimum sample amount for raw API powders: 200 mg
• Average turnaround time: 7 business days

Important Notice

• This analysis is specifically intended for raloxifene. It does not automatically screen the sample for other selective estrogen receptor modulators, related compounds, contaminants, or undeclared substances.
• For oral products, the minimum amount of raloxifene required for evaluation is 5 mg per pill, tablet, or capsule. For raw API powders, the minimum content is 10%. Samples below these values may not be reliably evaluated within the standard scope of the analysis.
• Purity reporting in % (m/m) is available only for raw API powders.

Optional Additional Analyses

The following optional laboratory services are available:

• Complete Raw Analytical Data
• Alternative Result Format: Purity in % (m/m) – only for raw API powders
• Batch Variance Testing
• Fentanyl Screening
• GC–MS Contamination Screening
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report