Pantoprazole Sod. Ip

The Indian Pharmacopoeia (IP) specifies Pantoprazole Sodium in detail to ensure its quality, efficacy, and safety for medicinal use. Here are the key specifications:

Identification: Methods to confirm the presence and purity of Pantoprazole Sodium, distinguishing it from other substances.

Assay: Quantitative determination of the potency of Pantoprazole Sodium, ensuring it meets specified levels of the active pharmaceutical ingredient.

Related Substances: Limits on impurities and degradation products to maintain purity and safety.

Residual Solvents: Maximum allowable levels of solvents used in manufacturing, ensuring the product is free from harmful residues.

Loss on Drying: Measurement of moisture content to maintain stability and prevent degradation of the active ingredient.

Heavy Metals: Strict limits on toxic heavy metals like lead, arsenic, mercury, and cadmium, ensuring product safety.