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APIs

Gastrointestinal APIs

Proton pump inhibitors, H2 blockers, prokinetics, antispasmodics and laxatives for gastrointestinal formulations, from pilot to commercial scale.
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Gastrointestinal drugs treat acidity, motility disorders, spasm and constipation, and several of them rank among the most prescribed generics. This sub-category supplies proton pump inhibitors such as Esomeprazole, the H2 blocker Famotidine, prokinetics including Domperidone, antispasmodics like Dicyclomine HCl, Drotaverine HCl and Hyoscine Butylbromide, the urinary antispasmodic Flavoxate and the laxative Bisacodyl.

Proton pump inhibitors are acid-labile and sensitive to moisture and heat, which affects both API handling and formulation. Esomeprazole is supplied as a magnesium or other salt, often in a specified hydrate form, and is formulated with enteric protection. Buyers should state the salt, hydrate and pharmacopoeia, as well as any limits on specific degradation products.

APIs are shipped in sealed, light-protected containers with desiccant where needed, accompanied by the manufacturer's COA and an SDS. For impurity work on these molecules, related standards are listed on our impurity standards pages.

Gastrointestinal APIs: questions buyers ask

Why does esomeprazole need careful storage?
Esomeprazole and other benzimidazole proton pump inhibitors degrade quickly in acid, moisture, heat and light, forming coloured degradation products. Store the API tightly sealed, cool and dry, protected from light. Limit exposure during dispensing, and check appearance and related substances if storage conditions were not met.
Which salt of esomeprazole should I order?
Esomeprazole magnesium is the most common salt, typically as the trihydrate or dihydrate, while the sodium salt is used for injections. The form influences stability and dose calculation. Match the salt and hydrate to your reference product and dossier, and state it on your enquiry.
Is hyoscine butylbromide the same as hyoscine hydrobromide?
No. Hyoscine butylbromide is a quaternary derivative that acts mainly on the gut and crosses the blood-brain barrier poorly, so it is used for abdominal cramps. Hyoscine hydrobromide acts centrally and is used for motion sickness. They are different APIs with different monographs and should not be substituted.

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