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Naming of Drug Products Containing Salt Drug Substances

Naming of Drug Products Containing Salt Drug Substances 2025

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The Manual of Policies and Procedures (MAPP 5021.1 Rev.1) outlines the application of the United States Pharmacopeia (USP) Salt Policy for naming drug products containing salt drug substances. It establishes guidelines for the consistent use of active moiety names instead of salt names in drug product monographs, effective since May 1, 2013. The document details procedures for determining exceptions to this policy, ensuring accurate labeling to prevent medication errors, and providing clarity on dosage forms and strengths based on active moieties.

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Click ‘Get Form’ to open it in the editor.
Begin by reviewing the 'Purpose' section, which outlines the application of the USP Salt Policy. This will help you understand the context for naming drug products containing salt drug substances.
Proceed to fill out the 'Background' section. Here, ensure that you accurately identify whether your product contains an active ingredient that is a salt and note any exceptions that may apply.
In the 'Procedures' section, follow the outlined steps carefully. Confirm that your labeling meets statutory requirements and includes necessary equivalency statements regarding active moieties and salts.
Finally, review all entries for accuracy before saving or exporting your completed form. Utilize our platform's features to easily share or sign your document as needed.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is an example of a drug in salt form?

The salt form of the active ingredient is used to alter the physical or chemical properties of the medicine, such as solubility, pH, stability and shelf life, and bioavailability.

What is USP salt?

A pharmaceutical salt is a crystalline form that is commonly used to change pharmaceutical properties, such as solubility, dissolution, stability, or bioavailability. Salts can be used in early development for animal pharmacokinetic studies, in human clinical trials, and in marketed products.

Why are some drugs in salt form?

Morton USP Sodium Chloride is a purified salt which meets United States Pharmacopeia standards. Morton is the only US supplier with multiple USP Sodium Chloride producing plants. The crystals are cubical or granular in form.

What is an example of a salt form of a drug?

The top five salts used include sodium chloride (NaCl), potassium chloride (KCl), magnesium chloride (MgCl2), calcium chloride (CaCl2) and sodium hydroxide (NaOH).

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