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The quality, purity, and efficacy of an API are vital to ensuring the safety and effectiveness of the final pharmaceutical product. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines and standards for the production and testing of APIs. Manufacturers must comply with Good Manufacturing Practices (GMP), which outline the necessary controls and documentation to guarantee that APIs are consistently produced to quality standards.
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2. Increased Heart Rate Theophylline can stimulate the heart and lead to an increased heart rate (tachycardia). While a slightly elevated heart rate can be tolerated, significant increases can pose risks, especially in dogs with pre-existing heart conditions. Owners should monitor their pets and report any unusual behaviors or changes in heart rate to their veterinarian.
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