Description

Aspirin, Butalbital And Caffeine Drug Combination is a precisely formulated active pharmaceutical ingredient (API) blend designed for therapeutic use. This combination is critical for the effective and reliable production of analgesic and sedative medications targeting specific pain syndromes. It is primarily required by pharmaceutical manufacturers and compounding pharmacies for the development of prescription drug products. The compound is identified by CAS number 51005-25-5.

Application

This API combination is engineered for specific therapeutic formulations. Its primary and related applications include:

• Prescription Analgesic Formulations: As the core active component in medications for tension headaches and migraines.
• Compound Pharmacy Preparations: For customized dosage forms tailored to individual patient needs under medical supervision.
• Pharmaceutical R&D: Serving as a reference standard or starting material in the development of new combination therapies.
• Generic Drug Manufacturing: For the production of bioequivalent versions of branded combination analgesic drugs.
• Clinical Trial Material: Used in the manufacturing of drugs for Phase I-IV clinical studies.

Basic Information

Product Name	Aspirin, Butalbital And Caffeine Drug Combination
CAS No.	51005-25-5
Molecular Formula	C9H8O4 • C11H16N2O3 • C8H10N4O2
Molecular Weight	180.16 (Aspirin) + 224.26 (Butalbital) + 194.19 (Caffeine) = 598.61 g/mol (Combined)
Synonyms	ASA/Butalbital/Caffeine; Acetylsalicylic Acid/Butalbital/Caffeine; Fiorinal API Combination; Butalbital Compound; Analgesic-Sedative Combination API; 5-Allyl-5-isobutylbarbituric acid/Aspirin/Caffeine; Itobarbital/Aspirin/Caffeine Combination
EINECS	Contact for details

Quality Control

Our Aspirin, Butalbital And Caffeine Drug Combination is manufactured and tested to meet exacting pharmaceutical standards. Quality is assured through a comprehensive battery of tests including identification, assay, and impurity profiling. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with relevant specifications. We support audits and can supply documentation for regulatory submissions (e.g., DMF).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Description	White or almost white powder or compacted mass
Identification (IR)	Conforms to reference spectra for all three components
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	90.0% - 110.0% of labeled amount for each component
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 5.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Microbial Limits	Complies with Ph. Eur. 2.6.12 / USP <61>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.